Thermo Scientific BRAHMS KRYPTOR compact PLUS User Manual

B·R·A·H·M·S KRYPTOR
compact PLUS

User Manual | Version R08

106172 I SW 7.06.00 I Date 21.02.2018

B·R·A·H·M·S GmbH

B·R·A·H·M·S KRYPTOR compact PLUS User Manual (Version R08en) Page 2 of 30

Name REF

B.R.A.H.M.S KRYPTOR compact PLUS 106172
B.R.A.H.M.S KRYPTOR compact PLUS Reading Module 106174
B.R.A.H.M.S KRYPTOR compact PLUS Pipetting Module 106173
B.R.A.H.M.S KRYPTOR BUFFER 89970
B.R.A.H.M.S KRYPTOR compact SOLUTION 1 89981
B.R.A.H.M.S KRYPTOR compact SOLUTION 2 89982
B.R.A.H.M.S KRYPTOR compact SOLUTION 3 89983
B.R.A.H.M.S KRYPTOR compact SOLUTION 4 89984
B.R.A.H.M.S KRYPTOR compact DILCUP 89985
B.R.A.H.M.S KRYPTOR compact REACT 89986

B.R.A.H.M.S KRYPTOR compact PLUS:
Instrument and consumables

Content changes versus previous version

• Add new laser labels

• Add UDI, USA: Rx only and cTUVus labels

• Add information about preventive maintenance frequency by service engineer

• Modification of related software version

• Add CE and IVD label on back side

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Labelling ................................................................................................................................................................. 4

Safety Instructions ................................................................................................................................................ 6

Introduction ............................................................................................................................................................ 8

Instrument Components ....................................................................................................................................... 9

Description of the System Status Window ....................................................................................................... 11

Main Menus .......................................................................................................................................................... 12

The Tool Palette ................................................................................................................................................... 13

Work Surface Colour Codes ................................................................................................................................ 14

Sample Carousel .................................................................................................................................................... 14

Reagent Area ......................................................................................................................................................... 15

Reaction Area ........................................................................................................................................................ 16

Dilution Plate .......................................................................................................................................................... 16

B.R.A.H.M.S KRYPTOR compact SOLUTIONS 1 to 4 ........................................................................................... 17

Fluidic System ....................................................................................................................................................... 17

Routine Work ....................................................................................................................................................... 18

Start-up .................................................................................................................................................................. 18

Maintenance ......................................................................................................................................................... 18

Reagent registration .............................................................................................................................................. 19

Reconstitution of reagents .................................................................................................................................... 19

Perform a calibration .............................................................................................................................................. 19

Run controls ........................................................................................................................................................... 20

Run patient samples with barcode ........................................................................................................................ 20

End of day .............................................................................................................................................................. 20

Analytes with Pre-incubation ............................................................................................................................. 21

Important User Information ............................................................................................................................... 23

Barcodes Specifications ...................................................................................................................................... 25

Troubleshooting Guide ....................................................................................................................................... 26

Result Window Messages ..................................................................................................................................... 26

Degraded Mode ..................................................................................................................................................... 28

Contents

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Labelling

Symbol Explanation

Laser, danger to eyes

Location: on fluidic hood,
on barcode readers

Electrical risk

Location: high voltage power supply,
inside electronic boxes

Biohazard

Location: waste bottle plug, wash station,
waste pump, clot detection board

Thermal risk

Location: reaction area entrance

Electrostaticsensitive part

Location: inside electronic boxes

User hazard

Location: on sample and cooling trays

Caution - Class 3B invisible laser
radiation when open.

Avoid exposure to the beam

Location: on reader head shielding

Caution - Class 3B invisible laser
radiation when open and
interlocks defeated.

Avoid exposure to the beam

Location: on side panel, access to the laser

Laser light

Do not stare into the beam.
Class 2 laser product

Location: on fluidic hood

Symbol Explanation

Serial number

of Reading Module

Serial number

of Pipetting Module

Identification

of the machine

Alternative current (AC)

Humidity range

Temperature range

Medical device conforms to

IVD Directive 98/79/EC

Consult instructions for use

Medical device is CE certified
to conform with the
IVD Directive

Date of manufacturing

Name and address of the

Manufacturer

Protective nominal value

(Rating of electrical fuse)

Electric and electronic equipments
have to be selectively collected
under the manufacturer
respons ibility B·R·A·H·M·S GmbH

V~

T 5A

+18 °C

+30 °C

N

20 %

85 %

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Symbol Explanation

Product reference number

of the assembly

Barcode that provides UDI
information according to FDA
regulations

Federal law restricts this device
to sale by or on the order of a
licensed healthcare practitioner
(applicable to USA classification
only)

cTUVus logo

106172

USA: Rx only

Labelling of
B.R.A.H.M.S KRYPTOR compact SOLUTIONS

SGH 05 Corrosion

SGH 07 Exclamation Mark

B·R·A·H·M·S GmbH

B·R·A·H·M·S KRYPTOR compact PLUS User Manual (Version R08en) Page 6 of 30

The safety instructions of the User Manual allow the
user to avoid injury to persons, material damages and
environmental contamination.
It is mandatory for users of Thermo Scientific™
B.R.A.H.M.S™ KRYPTOR™ compact PLUS to pay
particular attention to SAFETY INSTRUC TIONS written
in the B.R.A.H.M.S KRYPTOR compact PLUS Manual.
Installation of the B.R.A.H.M.S KRYPTOR compact
PLUS can only be performed by a properly trained ser­vice engineer. At the time of installation all perfor­mance specifications will be verified. Any attempt to
install, repair or modify the instrument by unauthorized
personnel is not allowed.
The system has to be maintained every 6 months by
an authorized and qualified engineer following the
procedures described in the service manual that is
provided only to the qualified engineers.
This in vitro device must only be used by qualified and
trained personnel according to GMP guide lines. Local
health and safety regulations must also be taken into
account.
Reading and interpretation of results must be done by
a qualified user.
B.R.A.H.M.S KRYPTOR compact PLUS must only be used
with materials, equipment and accessories specified in the
B.R.A.H.M.S KRYPTOR compact PLUS Manual.
B.R.A.H.M.S KRYPTOR compact PLUS analyser is a
Class 2 laser product.

Caution: Use of controls or adjustments or performing
any procedures other than those specified herein may
result in hazardous radiation exposure.

Precaution for installation

Indoor use only
Altitude Up to 2000 m
Temperature range 18

…30 °C

Humidity 20-85% (non condensing)
Corrosion Protection against 1N HCl,

1N NaOH, decontamination
solution, bleached reagent

Electrical mains 100-240 V~, mains supply

voltage fluctuations up to
± 10% of the nominal voltage
50-60 Hz
Power 465 VA
Transient overvoltage: category II

Placement Clearance distance:

Behind: 5 cm
Side-left: 10 cm
Side-right: 20 cm
Disconnecting device should be
accessible.

Transport conditions -20

…70 °C

Long term storage 0

…50 °C

Input and output connections
Caution:

On the serial communication ports, connect only a
RS-232 link (Very low safety voltage).
On the USB port, connect only the specific USB cable
provided (Very low safety voltage).
On Waste bottle cap (liquid level and mechanical
sensor), connect only the specific cable provided (Very
low safety voltage).

Electromagnetic compatibility

Changes or modifications not expressly approved by
B·R·A·H·M·S GmbH could void the user’s authority to
operate the equipment.
B·R·A·H·M·S KRYPTOR compact PLUS is compliant
with class B product requirements as defined in IEC
61326-2-6 standard.
B·R·A·H·M·S KRYPTOR compact PLUS complies with
the emission and immunity requirements describ ed
in EN 61326-2-6. The electromagnetic environment
should be evaluated prior to operation of the device.
Do not use this device in close proximity to sources
of strong electromagnetic radiation (e.g. unshielded
intentional RF sources), as these may interfere with
the proper operation.

Electrical security

Do not connect B.R.A.H.M.S KRYPTOR compact PLUS
to a power supply before ensuring that the voltage
setting is correct.
The analyzer can be used with a power supply (mains)
voltage of 100-240 V~ (50-60 Hz). Verify the voltage of
the local power supply (mains) to be used. Always plug
the analyzer into a grounded outlet. Operating tech ­ni cians and maintenance personnel are urged to follow
sound electrical safety practices at all times.
Although all metal parts of the analyzer are at ground
potential (zero voltage), they should never be touched
with one hand while touching a plumbing fixture, radia­tor, AC-operated device or other grounded object with
the other.
Before opening the analyzer, remove the power cable
from the power outlet. Do not replace components or
attempt any repairs with the analyzer switched on.
Do not operate the analyzer in an atmosphere contain ­ing explosive gases since components of the analyzer
could generate sparks.
Avoid spilling fluid on or into the analyzer at any time.
All spills should be wiped up promptly.
If the equipment is used in a manner not specified by

Safety Instructions

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B·R·A·H·M·S KRYPTOR compact PLUS User Manual (Version R08en) Page 7 of 30

B·R·A·H·M·S GmbH, the protection provided by the
equipment may be impaired.

Biohazardous

When working with human serum, controls and cali­brators all accessible parts of the analyzer must be
consi dered as biohazardous. The pipette tip, sample
cassettes, reagent cassettes, carousel drip pan, and
analyzer deck should be routinely disinfected.
Concerning all areas exposed to patient potential
infectious material or to user contact follow the clean ­ing requirements and use 5% Hypochloride solution
for decontamination. (See B.R.A.H.M.S KRYPTOR com­pact PLUS Manual, chapter maintenance.)
It is strongly recommended to wear gloves and a
special coat.

Waste

The reagents and the waste must disposed of as
potential infectious laboratory waste according to local
regulations.

Dilution plate, reaction plate

Before disposing of the dilution plate as well as the
reaction plate stick the adhesive cover film with
bio hazard sign on the plate. The adhesive covers are
supplied with the plates.

B.R.A.H.M.S KRYPTOR compact SOLUTIONS 1 to 4

For detailed information read the safety instructions for
use inserts.
Safety data sheets are available at International Product
Support on request.

Laser

Concerning the sample carousel barcode reader (Class
2 laser) and the manual barcode reader do not look at
the laser. Avoid direct eye exposure.

Class 2 lasers are limited to a maximum output power
of 1 milliwatt and the beam must have a wavelength
be tween 400 and 700 nm. A person receiving an eye
exposure from a Class 2 laser beam, either accidentally
or as a result of someone else’s deliberate action (mis ­use) will be protected from injury by their own natural
aversion response. This is a natural involuntary res­ponse that causes the individual to blink and avert their
head thereby terminating the eye exposure. Repeated,
deliberate exposure to the laser beam may not be safe.
The laser inside the instrument (Class 3B laser) emits
an invisible radiation whose characteristics are the fol­lowing:

Laser Type LTB SRS

Beam Deviation (mrad) 3*3 5*8

Pulse Length (ns) 2.5 <3.5

Max Peak Power (kW) 100 45

Repetition Rate (Hz) 20 20

Class 3B lasers may have sufficient power to cause an
eye injury, both from the direct beam and from reflec­tions. The higher the output power of the device the
greater the risk of injury. Class 3B lasers are therefore
considered hazardous to the eye.
The laser is only accessible by opening the instrument
cover. The instrument cover (side access panel) is
equipp ed with a safety interlock, which stops laser
beam im me dia tely.

For further information see latest version of
B.R.A.H.M.S KRYPTOR compact PLUS Manual and
latest version of B.R.A.H.M.S KRYPTOR instruc­tions for use for reagents and consumables.

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Intended use

B.R.A.H.M.S KRYPTOR compact PLUS is a fully auto­mated system for in vitro diagnostic. B.R.A.H.M.S
KRYPTOR compact is an autoanalyser which can
perform biochemical investigations.
It is used for measurement of patient samples in
random access mode routinely.
B.R.A.H.M.S KRYPTOR compact PLUS is a closed
system and can only operate utilising special reagents
offered by B·R·A·H·M·S GmbH. The system is based
on TRACE technology (Time-Resolved Amplified Cryp­tate Emission). The system and the reagents are under
con tinuous develop ment by B·R·A·H·M·S GmbH.

TRACE – the unique measuring principle
of B.R.A.H.M.S KRYPTOR compact PLUS

The measurement principle of B.R.A.H.M.S KRYPTOR/
KRYPTOR compact is based on TRACE technology,
which measures the signal that is emitted from an
immuno complex with time delay.
The basis of the TRACE technology is non-radiative
energy transfer from a donor to an acceptor.
The proximity of donor and acceptor when they are
part of an immunocomplex and the spectral overlap
between donor emission and acceptor absorption
spectra on the one hand, intensify the fluorescent
signal of the cryptate and on the other hand they
extend the life span of the acceptor signal, permitting
the measure ment of temporally delayed fluorescence.

Precise measurement of analyte concentration

When the sample is excited with a nitrogen laser at
337 nm, the donor emits a long-life fluorescent signal
in the milli-second range at 620 nm, while the acceptor
generates a short-life signal in the nanosecond-range at
665 nm or 707 nm depending on the type of acceptor.
When the two components are bound in an immuno­complex, both the signal amplifi cation and the prolong ­ed life span of the acceptor signal occur at 665 nm or
707 nm, so that it can be measured over µ-seconds.
This long-life signal is proportional to the concentration
of the analyte to be measured.

Introduction

Reliable prevention of interference

Non-specific signals are eliminated by the internally
calc ulated ratio of the intensities at these wavelengths
(665/620 or 707/620).
The signal generated by the cryptate at 620 nm serves
as an internal reference and is measured simul t ­ane ously with the long-life acceptor signal at 665 nm or
707 nm. Interfering influences, e.g. from turbid sera,
are automatically corrected.

Amplification
by energy
transferDonor

Bound
acceptor

Unbound acceptor

Life span of the
bound acceptor
signal / time-resolved

Life span of the
unbound acceptor signal

Unbound acceptor

Immunocomplex

Excitation
of the sample
at 337 nm

Excitation
of the sample
at 337 nm

10 nsec

µsec

Long-life
acceptor signal
at 665 or 707 nm

Time in µsec

Time in nsec

Intensity

Short-life
acceptor signal
at 665 or 707 nm

Intensity

0.5

620 665 λnm

1

Signal relation 665/620 = 1

Fluorescence intensity

Donor
Acceptor

0.5

620 665 λnm

1

Signal relation 665/620 = 1

Fluorescence intensity

Donor
Acceptor

T = 100%

T = 50%

Internal correction of interfering influences

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2

3

4

1

Instrument
Components

presence. Levels of buffer and distilled water are
managed by float switches within the main body of
the instrument. When the bottle becomes red on the
VDU screen, it is possible to refill the bottles without
interruption to the current run. There is no fluid sensor
on these two bottles.

Carousel

The carousel is di vi ­d ed into 5 posi tions.
Positions 1, 2 and 3
are hybrid locations
which allow to put
reagent or sample
trays. Positions 4

and 5 are dedicated
only for sample trays. When the hood is open, it is
possible to turn the carousel by hand to simplify
access to each position.

3

This instrument has two parts: pipetting module
and reading module.

Pipetting Module

This part comprised a pipetting unit , fluidic system

and carrousel .

Pipetting unit

The pipetting unit consists of a heated tip sample
probe and a wash station. The heated tip uses a
capacitive liquid level detection system to aspirate
all components required to perform the biological
analysis. This includes the sample, diluent and
reagents. After aspirating the sample and reagent
components into the tip, the tip is heated to reac­tion temperature and acts as a pre-reaction incuba­tor. This ensures that the fluids are at reaction tem­perature before dispensing in to the reaction area.
At the end of dispense, the tip is washed to avoid
carry-over contamination between samples.

Caution, any fluidic hood opening stops tip motion.

Fluidic system

The fluidic system includes 3 bottles of 5 liters.
One for the PBS wash liquid (BUFFER; order code for
the buffer: B.R.A.H.M.S KRYPTOR BUFFER) used to
wash the tubing system after pipetting. A second
bottle with distilled or deminerialized water used as
liquid system (DISTILLED WATER) by priming before
pipetting and to keep the tubing line in water during
instrument stand by or switch off. A third bottle is
used to collect liquid waste (WASTE). Only the waste
bottle contains a float sensor on the cap to manage
the liquid level and a mechanical sensor for bottle

2

1

2 3

1

Distilled or demineralized
water tank with floating
switch

PBS Tank with floating
switch

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SOLUTIONS 1, 2, 3 and 4 (order code B.R.A.H.M.S
KRYPTOR compact SOLUTION 1-4)
The SOLUTIONS 1 and 2 are used for reconstitution
of freeze dried reagents. The SOLUTIONS 3 and 4 are
needed for different washing steps between pipet­ting reagents and samples. Their use depends on the
analytes. Do not top-up the bottles. Each solution
bottle is managed on the instrument by the software
through a barcode placed on the top of the bottle.
SOLUTIONS 1 and 2 are mandatory to launch recon­stitution of reagent kits. SOLUTIONS 3 and 4 are
mandatory to launch pipetting sequence for samples.

DILUTION PLATES (order code B.R.A.H.M.S
KRYPTOR compact DILCUP)
The dilution plate, which consists of 24 wells, is used
by the system to reduce a high concentration or make
a recovery test by using a diluent or a specific reagent.
A barcode placed on the convex side of the plate,
allows the software to monitor the availability of wells
and lifetime on board the instrument.

Reading Module

Power on or off of the complete instrument is done
with the button O/ I placed on right side of reading
module. This module consists of the reaction area
and optical reading system to measure the signal
emitted by the immuno complex. The reaction
plate contains 96 wells (order code B.R.A.H.M.S
KRYPTOR compact REACT) and its life on board the
instrument is moni tored by the software through a
barcode placed on each reaction plate and transpa­rent damper closing. The reaction plate is heated at
37 °C ± 0.5 °C.

Handheld barcode reader

All relevant information concerning calibrators, con­trols, reagent lots and reaction plate barcodes are
registered on B.R.A.H.M.S KRYPTOR compact PLUS
by the barcode reader as well as reaction plate bar­code.

5

4

Reagents tray

This accessory contains up
to 4 reagent kits. The cool ­ing system (2...8 °C) is ope­rational only when the tray
is installed on the carousel
and the ins trument is turned
on. An infrared system is

used to detect reagent seg­ments during movement of the carousel. Barcoded
identification of reagent kits is automatically scanned
when the carousel rotates. Caution: Put the kit in
right order, barcode must be visible within the per­spex window (refer to photo). Inventory for all
reagent kits and reagent segment temperature is
fully managed by the software with use of colour
codes.

Tray for samples, dilution plates and
SOLUTIONS 1-4

This tray has space for 16
sample tubes which can be
any combi nation of primary
or second ary tubes at a
height between 60 mm and
120 mm and a diameter
between 11 mm and 17 mm.
Calibrators, con trols and mi ­cro- cups in a specific metallic adaptor can also be
installed. This tray also has space to install SOLU ­TIONS 1-4 or dilution plates. Sample trays are
detected on board by barcode identific ation placed
on the top and the middle of the segment.

5

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Description of the System Status Window

ACCESS TO MAIN MENUS

B.R.A.H.M.S KRYPTOR compact PLUS
TOOL BAR

WINDOWS COMMAND BAR

WINDOWS START BUTTON

WINDOWS TASK BAR

STATUS BAR

B.R.A.H.M.S KRYPTOR compact PLUS
WORK SURFACE

7

2

3

4

5

6

1

Waste

Distilled or demineralized water: Liquid system

Buffer PBS: Phosphate Buffer Saline: Wash
liquid

B.R.A.H.M.S KRYPTOR compact
Wash Solutions

Dilution plates

Sample tray

Reagents tray

Reaction plate

8

7

6

5

4

3

2

1

1

2

3

4

5

6

7

1

2

3

4

6

5

7

8

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Main Menus

SYSTEM

* Logon

* Shutdown

* Maintenance

* Maintenance Log

* Session Log

* Service Diagnostics

* Printer Setup

* Close

DATA

* Worklist

* Results

* QC

Functions

* Work

Analysis

INSTRUMENT

* Rescan Carousel

* Start Processing

* Pause Processing

* Query All

* Prime

* Reconstitute Kits

* Reaction Plate

* Sample Carousel

* Reagents

REGISTRATION

* Calibrator/Standard

* Control

* Reagent Lot

ADMINISTRATION

* Panels

* Analytes

* Combined Analytes

* Reflex Testing

* User Accounts

* Instrument Params

* LIS Interface

* Preferences

HELP

* User Manual

* About

These menus are available by clicking on:

The main menus bar appears

To close it, click again on:

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The Tool Palette

ICON COMMAND

Scan Carousel

Start Processing

Pause Processing

Manage

Worklist

Validate

Results

QC Functions

Reagent Lot

Manager

Calibrator Lot

Manager

Prime Instrument

Reconstitute

Reagents

Advanced Menu

User Manual

Load/unload the

Reaction plate

System Logon

procedures

System Shutdown

procedures

FUNCTION

F1

F2

F3

F5

F6

F7

F8

F9

F10

F11

MENU OPTION

Instrument

Rescan Carousel

Instrument

Start Processing

Instrument

Pause Processing

Data

Worklist

Data

Results

Data

QC Functions

Registration

Reagent Lot

Registration

Calibrator/Standard

Instrument

Prime

Instrument

Reconstitute Kits

Help

Instrument

Reaction Plate

System

Logon

System

Shutdown

DESCRIPTION

Identification of samples without starting a run

This icon disappears after click on it to give access

to Pause processing.

This icon appears after Processing has started.

Addition of more samples to the carousel.

If you push the blue button on the front of the

instrument, at the end of pause, carousel hood is

open automatically.

If you use this icon, at the end of pause it is needed

to click on the blue button to open the hood.

To close it, click again on the icon.

Allow to load reaction plate by plate ID manual entry.

Allow to unload reaction plate.

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COLOUR EXPLANATION

Black: no sample present

Dark green: the sample is ready to be tested

Dark green with a white point: sample during pipetting process

Dark green with a red circle: STAT sample

Blue: sample to be removed (all the tests of this sample have processed successfully including

the out of range detection)

Yellow: sample with barcode without test in worklist or presence on carousel of same ID on different sample tube

Red: problem with sample processing

(e.g. reagent related, consumables related; clot, insufficient sample volume)

Red with a white point: sample during pipetting process with at least one test with problem

Work Surface Colour Codes

Sample Carousel

At the end of carousel scan, all samples with a barcode and tests in the worklist will be shown in green, blue, yellow or
red. If the system is connected to LIS, there are different colours for the sample status (see Administration Menu/
LIS interface in B.R.A.H.M.S KRYPTOR compact PLUS Manual).

An information window is available by clicking with the left button of the mouse on a selected sample.

In case of sample tubes without barcodes, it is possible to identify a location in the sample tray by manual entry
through the Carousel Status window, or the worklist.

Double click on sample tube to open Carousel Status window.

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Reagent Area

Each reagent cassette has its own identification. An information area appears by clicking (left button of the mouse)
on reagent tray screen image, this shows cassette ID and temperature in degrees of the kit.

A colour code on the circle portion exists as a quick visual check of the right temperature in the reagent area or a
reagent cassette’s fan fault.

All reagent kits detected by barcode are shown on screen in the appropriate reagent cassette. A more detailed infor­mation Window is available by clicking (left button of the mouse) on a reagent kit.
The colour of the background indicates the availability of the kits and the colour of the rectangle indicates the number
of remaining tests.

Double clicking anywhere in the reagent area opens the Reagent Status window. This window enables you to
display information about each reagent kit installed in the reagent area of the instrument and to request calibration
for each reagent kit.

TEMPERATURE BAR ON THE REAGENT AREA

Green: 2.0…8.0 °C

Blue: < 2.0 °C

Red: > 8.0 °C or communication failed

Yellow: one or more reagent cassette’s fan is out of order

COLOUR

White background: Kit OK (calibration and reconstitution OK)
Red rectangle: Number of tests remaining: ≤ 5

White background: Kit OK (calibration and reconstitution OK)
Yellow rectangle: Number of tests remaining: > 5 – ≤ 10

White background: Kit OK (calibration and reconstitution OK)
Green rectangle: Number of tests remaining: > 10

Yellow background: Kit or calibration expires tomorrow
Green rectangle: Number of tests remaining: > 10

Red background: Kit to reconstitute, to calibrate or expired kit or no test remaining

COLOUR

EXPLANATION

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Reaction Area

Each reaction plate is barcode labelled to allow the loading of the plate. The reaction plate has to be loaded to
activate its preheating and to allow the dispensing of samples.
Click on the plate to view the exact number of tests dispensed and completed. When the reaction plate is full,
there is no automatic unloading, it is necessary to request by clicking on reaction plate. A reaction plate not used
but unloaded could be loaded again during 2 hours after its first loading.
There is no automatic shutdown (machine remains in ready stage). As long as the reaction plate is on board, it is
ready to be used, until 7 days are passed or plate is full. After 7 days, the plate is automatically unloaded at the
next end of day (first ready or initialized stage after midnight).
Time validity status of reaction plate is available when clicking with the left mouse button on the reaction plate on
the screen. If there is an “xy position error”, the plate is automatically unloaded, and cannot be used any more.

Pipetting sequence does not start if the reaction area temperature is below to 35.7 °C or over 38.5 °C.

Dilution Plate

Each dilution plate is barcode labelled to manage the wells used and the shelf life on board (365 days). Check
dilution plate cleanness during daily maintenance.

COLOUR

EXPLANATION

White well = available well / coloured well = used well

Green: More than 10 wells available

Yellow: From 5 to 10 wells available

Red: Less than 5 wells available or expired

COLOUR EXPLANATION

Green: Proportion of tests running and not completed

Blue: Proportion of tests completed

Green: 36.2…38.0 °C

Blue: < 36.2 °C

Red: > 38.2 °C

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B.R.A.H.M.S KRYPTOR compact SOLUTIONS 1 to 4

For SOLUTIONS 1 and 2, the dead volume has been defined to finish a reconstitution started even if red level is
detec t ed; it is normal to have around 12 mL in SOLUTION 1 and approximately 8 mL in SOLUTION 2 when red
status appears on the interface screen. For SOLUTIONS 3 and 4 the dead volume is around 4 mL, defined to finish
wash step.

COLOUR

EXPLANATION

Green: OK

Yellow: Take care to change the bottle soon / solution expires tomorrow

Red: Bottle to be replaced = dead volume reached or solution expired

Fluidic System

An intermediate tank system enables you to refill B.R.A.H.M.S KRYPTOR BUFFER or distilled/demineralized water
bottle when red status is detected without stopping the current run by use of dead volume in intermediate tank
system. If the dead volume is used then waste red level is detected and the instrument stops at the end of current
run or prime. A prime is mandatory after refilling a bottle.

COLOUR EXPLANATION

Green: OK

Red: Waste bottle full (void), buffer or water bottle empty (filling), intermediate waste collector full (Call Hot Line)

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B·R·A·H·M·S KRYPTOR compact PLUS User Manual (Version R08en) Page 18 of 30

Routine Work

Start-up

Fill the appropriate bottles with distilled or deminerali­zed water and buffer PBS, empty the waste bottle.
Ensure B.R.A.H.M.S KRYPTOR compact SOLU TIONS 1
to 4 are on board. If B.R.A.H.M.S KRYPTOR compact
SOLUTIONS 1 to 4 are closed, open the caps. Put caps

into specific loca tions and inscribe the caps with
number of solution.

Check the fluidic and carousel hoods are closed.

After a power off

- Check if carousel hood is closed.

- Switch on the instrument with O/I (ON/OFF) button
found on right side of the instrument.

- Switch on the XPC, monitor, printer.

- Click on Windows Start button and choose

icon to launch the B.R.A.H.M.S
KRYPTOR compact software.

2 programs will be start ed:

1) XPC program is the user interface.

2) Check if XIPC program is active by icon presence on
clock bar.

After a Shutdown start here

- Check if carousel hood is closed.

- Click on

- Select Name and Password (e.g. user: Admin and
pass word: Admin) in the System LogOn window.

- An automatic scan is launched after motor initializa­tion. System is ready to use at the end of scan.

- An automatic scan is done every two minutes when
carousel hood is closed to manage reagent tray
tempera ture.

- Do maintenances as requested.

- Place a new reaction plate, close the transparent
damper and load it by scanning the barcode.

- Request carousel hood opening by pressing on the
blue button in front of carousel.

- If there is no reagent cassette, load one or more on
specific positions.

- Check status of dilution plate and B.R.A.H.M.S
KRYPTOR compact SOLUTIONS 1 to 4 on interface,
according to necessity, change or load new consum ­ables.

- Load kits on reagent tray when temperature status is
green.

- Ensure the reagent lid is well closed.

After an automatic change of day

The automatic change of day procedure is launched every
day, on the first ready or intialized stage after midnight.
This will perform automatically all the initializations (init
pipetor + init reader).
Nevertheless, the user will have a logon to perform
manual maintenances and database maintenance.
User is warned that he has to logon with the message
“KRYPTOR compact – Change of day made – Mainten­ance needed” in the title of the window.
User can go on using the analyser, without logon, in
case of use by night team, who wants that mainten­ance is performed by “morning team”.

Maintenance

Items on the maintenance screens only need to be per ­formed if they are marked *Expired*.
(!) These procedures will be performed automatically
when the system has been started.

Daily maintenance

- Initialize pipettor (!). To be done only if problems

occur during run on pipettor module.

- Initialize reader (!). To be done only if problems

occur during run on reader module.

- Prime Liquid Handling System (!). Check visually

the absence of leaks and bubbles during the priming
procedure.

- Check and clean reader head window by using a

cotton-swab first with water then with alcohol.

- Check and clean condensation in Reagent cassettes

with absorbent paper.

- LIS end of day. This action enables to purge LIS files

and avoid the occurrence of data transmission pro­blems.

- Check dilution plate cleanness. Look at dilution

plate already on board if there is no dirty particles in
dilution well.

Weekly maintenance

- Check for liquid leaks. Open fluidic hood to check

the tubing system (tubing connectors, syringes).
When fluidic hood is closed, pipettor initialization is
automatically done.

- Tip path cleaning with decontamination solution

to clean up serum splashes with a paper towel
slightly wet with water, then repeat with alcohol or
specific product to decontaminate.

- Backup DataBases. Backup of all databases older

than 3 days.

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- Backup Log Files. Backup of log of run and main ­tenance log files.

- Remove messages from box office. This action
enables the purge of the box office and avoid the
occurrence of data transmission problems.

- Cleaning of water bottle. Empty and replace dis tilled/
demineralized water if it is more than seven days old.

- Clean carousel pan. Clean the tray under the sample
carousel with a paper towel slightly wet with water,
then repeat with alcohol or specific product to decon­taminate.

Monthly maintenance

- Bottles decontamination. Empty the bottles and
pour in 1 liter of 5% sodium hypochlorite solution. Fit
a bottle cap and swirl the liquid inside the bottle so
that it comes into contact with all the internal sur ­faces. Allow to stand for 15 minutes, then empty and
rinse the bottle with water.

- Secure tip cleaning. Tip parking over night or if instru-
ment is not in use for a longer time. B.R.A.H.M.S
KRYPTOR compact SOLUTION 3 and 4 must be ava il ­able.

- Automatic check dot. Tip coming on dot point. If
adjustment is correct, tip coming back to wash cup.
In case of adjustment problem, user should open the
fluidic hood and check if tip can be slightly bent to
enter the hole.

Reagent registration

For the following working steps installation of valid
version of K-DISK ANA is needed.

Necessary when using new lots only:

Reagent

- Click on Reagent Lot Manager:

- Click on Register.

- Scan the barcode sheet.

- Click on OK and confirm the registration with Yes.

Calibrator

- Click on Calibrator/Standard Manager:

- Click on Register.

- Scan the barcode sheet.

- Click on OK and confirm the registration with Yes.

Control

- Click on:

- Click on:

- Click on Register new Controls.

- Scan the barcode sheet.

- Click on OK.

Reconstitution of reagents

- Click on to start reconstitution process.

- All freeze dried reagent kits placed in the instrument
will be reconstituted.

- In the status bar the progression of the reconstitution
in % is visible.

Perform a calibration

Calibrator

- Double click on the kit you want to calibrate.

- Select a calibrator lot from the drop-down arrow list.

- Click on Add to worklist, OK, Close.

- Request a carousel hood opening by pressing on blue
button in front of instrument.

- Place the calibrator tube on the sample car ­ousel making sure the barcode fills the slot.

- Close the carousel hood.

- Start the instrument:

Results

- Open results list:

- Select the calibrator result and click on Validate curve.

- The software indicates if the new calibration curve is
acceptable or not:

if Yes click on:
if No click on:

Run controls

Control

Adding a Control through Worklist

- Select Add control in the Data, Worklist:

- Select a control from the list, press Add to worklist,

Close, Close.

Adding a Control to be tested on specific reagent
kit

- Double click on the kit which should be used to measure
the controls.

- Select Control lot from the drop-down arrow list.

- Select Low volume and/or Stat status for this control.

- Click on Add to worklist, OK, Close.

- Request a carousel hood opening by pressing on blue
button in front of instrument.

- Place the control tube on the sample carou­sel making sure the barcode fills the slot.

- Close the carousel hood.

- Start the instrument:

Results

- Open results list:

- If result is in “needs resolution” status related to con­centration out of 2SD range (shown in red) or with
flag, check the information and validate, reject or
relaunch the test. Accept ing the control automatically
sends the result to the QC program.

- Select the B.R.A.H.M.S KRYPTOR compact Quality
control program to follow control life.

Run patient samples
with barcode

Patient Samples with barcode

- Select Add sample from Data, Worklist:

- Enter the Sample ID. Cassette ID and Tube position
are mandatory in case of sample without barcode.

- Select tests and dilutions from the displayed list, Add.

- Click on Stat to pipette a sample in priority.

- Click on Low volume sample vial if sample is in
microcup.

- Select Save sample and continue with required
samples, Close.

- Request a carousel hood opening by pressing on blue
button in front of carousel part.

- Place sample tubes on the carousel making
sure the barcode fills the slot.

- Close the carousel hood.

- Start the instrument:

Results

- Open results list:

- Select a test.

- It is possible to Cancel tests in detecting, or counting
step or in pending, only in “Ready/…” status.

- Results needing resolution can be: Accepted, Re-run
or Rejected.

- Select the results then Print Status or Print Report
to print results.

End of day

Shutdown (stand by modus)

- Check inventory of reagents on board for tomorrow’s
workload.

- Check the level of waste, distilled or demineralized
water and B.R.A.H.M.S KRYPTOR BUFFER.

- Check if the B.R.A.H.M.S KRYPTOR compact SOLU­TION 3 and 4 is on board.

- Select and confirm with Yes.

- Unload the reaction plate and confirm the popup
window with OK.

- Close the transparent damper and confirm the popup
window with OK.

To power OFF the instrument

- Remove dilution plate(s), samples, and reagents.

- Close carousel hood.

- Select and confirm with Yes.

- Unload the reaction plate and confirm the popup win­dow with OK.

- Close the transparent damper and confirm the popup
window with OK.

- Instrument is washing, wait for the completion of
steps (SOLUTION 3 and water washing) in case of
instrument power off.

- Close B.R.A.H.M.S KRYPTOR compact software:

- Close Windows by clicking on Start and Turn off.

- Switch OFF the PC, screen, printer and instrument.

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B·R·A·H·M·S KRYPTOR compact PLUS User Manual (Version R08en) Page 21 of 28

The assay of an analyte with a pre-incubation is com­posed of two phases:
Pre-incubation or Phase I: the system aspirates one
of the 2 conjugates and the antigen (sample). The
system dispenses the mixture into the reaction well
and the pre-incubation starts.
Phase II: the system aspirates the second conjugate
and dispenses it into the reaction well. At this moment
the Out of Range detection starts.
This leads to a specific operation of the interface
to avoid losing tests in Phase I distributed into the
reaction area.
The final test result will be achieved through Phase I
and Phase II using the same reagent kit.
To alert the user that a kit is in use for Phase I and is
required for Phase II, a padlock will appear on the user
interface at the edge of the reagent kit as shown
below. The kit should not be removed while the
padlock is displayed.

At the same time, a flashing red square will appear in
the top left corner of the screen.

The message behind the red square indicates the
estimated time in minutes and seconds remaining of
Phase I. There is also a number in parentheses to show
the number of tests in Phase I.

By reading this message the user can estimate the
time available to open and close the hood.

The padlock is removed when the reagent kit has no
tests remaining in Phase I, however the RED square
can remain active if other tests in Phase I are under­way.
If the buffer bottle, water bottle, one of the solution
bottles or the waste bottle is detected in red status
during Phase I or Phase II, pipetting will stop and a
popup window on interface informs to replace the
solution. In Phase II the carousel hood will be opened
by the system software and a beeping sound will alert
the user.
A user request to open the carousel hood during Phase
I is subject to confirmation by the user via a message
appearing on the screen.

Clicking on the “Yes” button allows the hood to be
opened with a beeping sound to alert the user and a
new text message next to the red flashing square indi­cating the time available for the user to close the hood.
Clicking on “No” led to the abandonment of the appli­cation to open the carousel hood.

When closing the carousel hood, the text indicates
the estimated time in minutes and seconds before the
distribution of Phase II.
When closing the hood, a carousel scan is performed.
If a reagent kit containing a pre-incubation test was not
found on board of the instrument, the user is notified
via a message displayed on the interface:

If the kit is not returned before the start of Phase II, any
tests in progress with this kit will be declared failed. At
the results list, the user can view the status of a test.

Analytes with Pre-incubation

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During Phase I, tests appear in blue with the message
pre-incubating:

The start time of a test is given after the start of Phase II.
If the test is failed during Phase I, the test is indicated
in red with an alarm: “System error: Pre-incubation has
failed.”

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Detailed information about consumables and
patient samples

By clicking and holding the left mouse button an infor­mation window appears.

1. Buffer

2. SOLUTIONS 1-4

3. Dilution plates

4. Reagent cassette

5. Patient samples

6. Reaction plate

7. Reagent

Sample ID barcode

It is forbidden to use a sample barcode starting with “R“
or “_“. In these cases, problems occur on interface.

Manual entry of consumables and reagents

In case of barcode reading problem, it is possible to
load barcode information by manual entry with the key­board. Click with the right mouse button on the corre­sponding area. A specific window for manual entry of
the barcode data will open.

When a consumable is loaded by manual entry, it is
marked by a symbol (not reaction plate) and on
session log.

If during a scan, a barcode is detected in place of
manual entry ID, scan reading has priority, ID con­sumable detected by scan erases manual entry ID.

This action is indicated in session log.

Interface drawing of tray positioning may differ from
actual tray position. For manual entry make sure that
place ments of reagent kits are done correctly as illust­rated below.

Reagent kit placement

Check the kit’s correct position in
reagent tray with kit notch towards to
the transparent window. A kit misposi­tioning could impact data results.

Caution

Manual identification of consumables or sample
tubes is under user responsibility. Entering incorrect
data may lead to wrong result. This option is to be
used only in case of barcode read

i

ng fault while

waiting for repair of problem cause.

Important User Information

Notch

1

2

3

4

1

2

3

4

1

2

3

4

4

3

2

1

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Pipetting/ Reading sequence

During pipetting/ reading sequence it is forbidden to
close interface to avoid to lose samples results or to
have bad behavior of results list management.

Clot management

A clot management is available on the system during
aspiration step on sample and dilution. The user is
warn ed of clot presence by two kinds of information.

Case 1:

Clot has been released into the tube, tip has been
washed before continuing the pipetting sequence.
Sample tube with clot is in red status with tests not
pipetted in cancel status, and test with clot problem
with flag “System error: clot detected”.
User intervention should be done on tube (clot removal
or sample tube change) before to launching new tests.

Case 2:

Clot could not be released, tip is blocked. This popup
appears to inform that pipetting sequence is stopped
with carrousel hood open.

Tip cleaning after fatal clot detection

• Open fluidic hood, place tip on Zhome position.

• Clean point of tip.

• Unscrew tubing on tip, liquid must flow out into

wash bowl.

• Disconnect tip electronic board, Caution to not bend

the tip point.

• Pass through a fish line (dia 0.45 mm) into the tip

from the small end towards the tip board.

• Clean by blowing with a neutral gas through the

tube from the small end.

• Connect tip electronic board on specific location.

• Close fluidic hood.

• Close carousel hood.

• Check dot point throught monthly maintenance

“Automatic check dot”.

• Launch a prime.

Help

Some help is available, in three languages (English,
French and German), through button or Help/User
Manual menu.

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Tube positioning: The tube must be straight and the

bars must visible throughout the window width.

A: Good position

B-C: Bad position, the barcode reader may not be able

to scan the code

Paper quality: A paper having a too high ink absorp­tion will give a blurred result and will decrease the
amount of good readings (this problem will have a
higher impact on barcodes having a low resolution).

Paper brightness: The barcode readers are very sens ­itive to the light reflection. Even though the barcode
reader is mechanically adjusted in order to limit the
light reflection a too glossy paper may affect the
reading performances of the codes.

Printing quality: The printer quality has an influence
on the reading performances. The best printers for
bar

c

odes are thermal printers (recommended for low
resolution barcodes) but most of the time a laser
printer is sufficient.

C

A: Printing quality is good.

Good contrast. Good resolution (accu­rate printing).

B: Printing quality is low.

The printer resolution is not good
enough. The contrast is not sufficient.

BA

B

Available symbologies on KRYPTOR instruments:

• Code 128

• Code 39

• Codabar

• Code 2/5 interleaved

• Code UPC/EAN

Other specifications:

• Minimum resolution: 0.21 mm
(size of narrowest bar (black or white bar))

• Minimum ratio = 2.5
(ratio of narrow bars to wide bars)

• Maximum ratio = 3.0

Silence section (blank section before and after the
code): at least 10 times the resolution (a silent section
before and after the code is mandatory for a good rea­ding otherwise the code cannot be recognized).

Barcode positioning: We recommend to stick the
label 5 mm above the bottom of the tube (if the code
is long and the label is stuck too high the barcode rea­der may have some difficulties to read the bars located
at the top, specially if the resolution is low (thin bars)).
At least a few bars from the barcode must be in the
window formed by the tube holder: the window will
determine the barcode position within the cassette.
The code must not be stuck entirely above the tube
holder because there is a risk of misidentification in
this case (a tube in position 2 may be seen in position
3 for example).

A B

C

A: Barcode position is acceptable but it’s not the best

position.

B: Best barcode position.

C: This barcode position is forbidden. At least a few bars

must be in the tube holder window.

Barcodes Specifications

A

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Troubleshooting Guide

Result Window Messages

FLAG NO. RESULT WINDOW MESSAGE WHAT TO DO

0 “System Warning: Low Laser Power”

• Call the Hot Line

1 “System Error: Reaction Plate position”

• Request a reader initialization in Daily Maintenance or restart the system
completely.

• Unload the reaction plate, check that the reaction plate was correctly
loaded and load a new reaction plate.

• If the problem persists, call the Hot Line.

2 “System Warning: Reagent Cooler out

of Range”

• Adjust the room temperature within the specification (between 18 - 30°C).

• Check if a reagent cassette fan is out of order.

• If the problem persists, call the Hot Line.

3 “System Warning: Incubator Out

of Range”

• Stop the B·R·A·H·M·S KRYPTOR compact PLUS and wait a few minutes
before switching on the instrument.

• Adjust the room temperature within the specification (between 18 - 30°C).

• If the problem persists, call the Hot Line.

4 “System Error: Missed Reading”

• Call the Hot Line.

6 “Error: Insufficient Sample Volume”

Check if the trouble occurs on one or several samples tubes, cup or
calibrator vials.

If it concerns one tube:

• check the liquid level in the sample cup, the sample tube or the calibrator vial.

• check the tube positioning in the carrousel.

If it concerns several tubes:

• Call the Hot Line.

7 “System Error: Insufficient Reagent

Volume”

• Check the liquid level in reagent bottles.

• Call the Hot Line.

9 “System Warning: Late T0/TM”

• If the problem occurs more than once in a series, shut down, and then
restart the instrument after 1 or 2 minutes. If the problem persists,
call the Hot Line.

• If the problem occurs sporadically while a significant work list is loaded
on B·R·A·H·M·S KRYPTOR compact PLUS, the problem is not relevant.
It is then advisable to relaunch the sample displaying this message.

11 “System Warning: Late TE”

• If the problem occurs more than once in a series, shut down, and then
restart the instrument after 1 or 2 minutes. If the problem persists, launch
an intervention. If the problem persists, call the Hot Line.

• If the problem occurs sporadically while a significant work list is loaded
on B·R·A·H·M·S KRYPTOR compact PLUS, the problem is not relevant.
It is then advisable to relaunch the sample displaying this message.

12 “System Error: Pipetting”

• Check obstacle in the path (Cap on sample tube…).
Remark: In that case, the carousel hood is open and the run is interrupted.

• Check the liquid level in vial.
Remark: In that case, test is in pending status. If following popup appears
<Error: tip level sense baseline. Contact technical support>, the carousel
hood is open and the run is interrupted.

13 “System Error: Clot Detected”

• Clean the tip (fish line, Secure tip cleaning from the monthly maintenance).

• Check the sample and relaunch the test.

• If the trouble persists, call the Hot Line.

14 “System Error: Pipetting in Sample area”

• Check obstacle in the path (Cap…).

• Check the sample tube positioning.

15 “System Error: Pipetting in Dilution area”

• Check the dilution plate positioning.

16 “System Error: Pipetting in Reagent area”

• Check obstacle in the path (reagent area lid, aluminium foil…).

• Check the reagent kit positioning.

17 “System Error: Pipetting in Wash area”

• Check if the SOLUTION bottles are present, open and if sufficient liquid
remains.

• Check if there is any obstruction on the path.

• If the problem persists, call the Hot Line.

18 “System Error: Pipetting in Reaction area”

• Check if there is any obstruction in the path.

• If the problem persists, call the Hot Line.

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FLAG NO. RESULT WINDOW MESSAGE WHAT TO DO

19 “System Warning: Heated Tip

Out of Range”

• Prime the system to remove bubbles.

• If the problem persists, call the Hot Line.

20 “System Error: Interrupted”

• Reboot the system.

• If the problem persists, call the Hot Line.

21 “System Warning: Not Performed”

• Start testing or delete it from the work list.

24 “Check Results”

• The software is working properly. If the “Flag report” option in the combined
analytes is checked, any flag on the individual tests A1 and A2 generates a “Check
results” message on the combined result which makes it only acceptable manually.

25 “Math Error”

• Call the Hot Line.

26 “Reflex Test Launched”

• It is not a problem, this is an information only.

29 “Clot detected or insufficient

sample volume”

Message occurs when a clot is detected too close to sample’s zmax.
The current test will be flagged in red.

• Clean the tip (fish line, Secure tip cleaning from the monthly maintenance).

• Check the sample and relaunch the test.

• If the trouble persists, call the Hot Line.

30 “Data Error: Unknown Error”

• Call the Hot Line.

31 “Data Error: Ratio”

• Call the Hot Line.

32 “Data Error: Response”

• Call the Hot Line.

33 “Data Warning: Abnormal”

• Prime the system to remove bubbles.

• Check the samples for bubbles.

• Check sample and reaction plate for dust.

• Check if there are any bubbles in the reaction plate.

• If the problem persists, call the Hot Line.

34 “Data Warning: Out of Range”

• Automatic dilution is started depending on the Preferences configuration in the
Administration menu.

35 “Data Warning: Detection Limit”

• Result lower than the lowest detectable concentration.

36 “Data Error: Above max. Range”

• Relaunch the test manually with a small dilution factor (1/2 or 1/5).

38 “Data Warning: Calibrator Warning”

• Start a calibration not later than the following day.

39 “Data Warning: Below Normal”

• Information that sample is below the cut off.

40 “Data Warning: Above Normal”

• Information that sample is above the cut off.

42 “Concentration not Consistent

with Dilution Used”

• Relaunch the test with another dilution. Use a lower dilution factor.

43 “Sample Pipetting Problem -

Check Sample”

• Check the sample for bubbles or foam and relaunch the test.

44 “Data Warning: Abnormal Kinetics”

• Prime the system and relaunch the test.

• Check the samples for bubbles.

• Check sample and reaction plate for dust.

• Check if there are any bubbles in the reaction plate.

• If the problem persists, call the Hot Line.

45 “_Data Warning: Second Response

Used”

• Information only when logon as Service.

46 “_Data Warning: Short Lived

Fluorescence”

• Information only when logon as Service.

48 “Data Warning: Control out of

2 SD range”

• Repeat measurement with a new aliquot of the control.

• Recalibrate the reagent.

• Use a fresh reagent box and reconstitute a fresh control vial.

51 “Inconsistent incubation time”

• Check in the result list the time of “end of test” and “start of test”. If the real
incubation time = theoretical incubation time + <4 minutes => the result can be
accepted. If not check if system is disconnected.

• Close the KRYPTOR compact PLUS program or restart the computer.

52 “System Error: Missed flashes”

• Call the Hot Line.

69 “Pre-incubating”

• Preincubation test, awaiting Phase II incubation.

70 “System Error: Pre-incubation has

failed”

• Pipetting problem during the Phase II.

• Reconstitution is required during the pre-incubation.

• No reagent unit on board at the end of the pre-incubation.

• The carrousel hood stills open at the end of the pre-incubation.

• Kit discrepancy because the diluent is empty (Insufficient reagent volume).

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Degraded Mode

When one of the following sensors has a malfunction
the local hotline can disable it to finalize the ongoing
measurement protocol. The sensors listed are installed
to warrant safe routine use. As the sensor malfunctions
do not affect the patient result they can be disabled. In
these exceptional cases the user has to follow the
precautions described below. This allows use of the
instrument until service engineer intervention.
After the local hotline has disabled a sensor, the
window “Securities disabled” appears on the inter­face.

When you click on the window, detail of sensors
dis abled is shown.

Specific conditions to use the instrument

Caution

The user must be careful when using the instrument
because the securities are off and some specific
conditions are mandatory. The user must follow the
advice given.

Fluidic Hood: The tip and the carousel may move
while the fluidic hood is open. The user must be vigilant
at each requested action on the interface (starting a
pipett

ing sequence, a carrousel scan, maintenances,

etc ...).

Lower Barcode Reader: Sample tubes and reagent
kits must be identified by manual entry. Refer to
„Important User informations“ for precautions.

Upper Barcode Reader: Sample cassettes are not
detected. Their positions are imposed on the carrou sel
in positions 4 and 5. The dilution plates and
SOLU TIONS 1-4 must be identified manually. Refer to
the “Important User Information“ for precautions.
Con sumables status (liquid level, dilution wells avail ­able,...) will be managed as usual.

Plexi Door: The Plexi door is the clear flap which is
lowered when loading a new reaction plate. The soft­ware no longer identifies if it is open or closed. Check
that the plexi door is closed before loading the reaction
plate to prevent damage to the reaction plate carriage.

Reader Front Door: This door is used to load the
reaction plate and the software no longer identifies if it
is open or closed. Check that the door is closed after
loading the reaction plate to avoid allowing light into
the reaction area and maintaining temperature control
of the incubator.

Silica Window: This is the Reader Head Window and
the heating is disabled. There are no special precau ­tions to be applied in addition to daily maintenance.

Clot Detection: The clot detection for samples is
dis abled, check samples before placing them on the
carousel.

Waste Status: The liquid level in the Waste bottle is
no longer managed as well as in the waste collector
placed below the washbowl. The status of the waste
is in green colour on the screen. Check waste level
before starting a pipetting sequence. Check that no
liquid comes out underneath the instrument.

IRDA Communication: IRDA is used to inform the
system about temperature of the reagent cassettes.
The temperature is still controlled accurately but it is
not reported to the system which leads to display of
the alarm “System Warning: reagent cooler out of
range” on all test results. The temperature status of
the reagent cassette appears in red on the screen.
When IRDA communication is OFF, the position of
the reagent cassette is imposed at location 1 of the
carousel. The identification of the reagent cassette is
R1. Reagent kits are always detected through the
lower bar code reader.

© 2018 Thermo Fisher Scientific Inc. All rights re serve d. All trademarks are the prope rty of Thermo Fisher Scientific and
its subsi diarie s unless otherw ise spec ified. Win dows is a registered trademark of Microsof t Corporation in the United
States and other countries. KRYPTOR and TR ACE are registered trademarks of CIS bio inte rnation al, licensed for use
by B·R·A·H·M·S, a part of Thermo Fisher Scientific. CEZANNE SAS ho ld exclusive rights in the B·R·A·H·M·S KRYPTOR
compact PLUS software.

Thermo Fisher Scientific products a re distributed worldwide; not all intende d uses and applications mentioned in this
printing are registered in every country.

106228.8

Find out more at thermoscientific.com/kryptor

[phone]
[phone] fax
info.brahms@thermofisher.com
www.thermoscientific.com/brahms

Thermo Fisher Scientific
B·R·A·H·M·S GmbH
Neuendorfstr. 25
16761 Hennigsdorf
Germany

Clinical Diagnostics

B·R·A·H·M·S GmbH
Neuendorfstr. 25
16761 Hennigsdorf
Germany

[phone]
[phone] fax
info.brahms@thermofisher.com
www.thermoscientific.com/brahms

www.thermoscientific.com/copeptin
www.thermoscientific.com/proadrenomedullin
www.thermoscientific.com/procalcitonin
www.thermoscientific.com/kryptor

International Product Support
CEZANNE SAS
Allée Graham Bell
Parc Scientifique Georges Besse
30035 N îmes Ce dex 01
France

[phone]
[phone] fax
productsupport.brahms.frnim@thermofisher.com

Date: 21.02.2018
This version supersede s all earlier User Manuals.
Soft ware 7.06.00

Kimby Barton, Interim Director, Medical Devices Bureau/Directrice intérimaire, Bureau des matériels médicaux

_________________________________________________________

* AMENDED *

* MODIFIÉE *

No d'homologation:

96541

Licence Number:

Première date de délivrance:

2016/02/12

First Issue Date:

2017/01/16

Application Number:
Numéro de la demande:

263153

116875

Manufacturer ID:
Identificateur du fabricant:

Date de modification:Amended Date:

La présente homologation est délivrée en vertu
de l'article 36 du Règlement sur les instruments
médicaux pour l'instrument médical suivant:

This Licence is issued in accordance with the
Medical Devices Regulations, Section 36,
for the following medical device:

Device Class/Classe de l'instrument: 2

16761

GERMANY

HENNIGSDORF

NEUENDORFSTRASSE 25

Manufacturer Name & Address/Nom du fabricant & adresse

BRAHMS GMBH

ADDITION OF DEVICES

Reason for Amendment/Raison de la modification

BRAHMS KRYPTOR

Licence Name/Nom de l'homologation:

Licence Type/Type d'homologation:

System / Système

Therapeutic Products Directorate
Medical Devices Bureau
Direction des produits thérapeutiques
Bureau des matériels médicaux

96541

LN/NH:

Santé Health
Canada Canada

Homologation d'un instrument médicalMedical Device Licence

Components/Parts/Accessories/Devices for this Licence

Les composantes, parties, accessoires et instruments médicaux pour cette homologation

BRAHMS KRYPTOR COMPACT PLUS

Device Identifier / Identificateur de l'instrument
(Model/Catalog Detail/No de modèle/Catalogue):

Device ID/No de l'instrument: 813302

106172

BRAHMS PCT SENSITIVE KRYPTOR

Device Identifier / Identificateur de l'instrument
(Model/Catalog Detail/No de modèle/Catalogue):

Device ID/No de l'instrument: 813303

825.050

BRAHMS PCT SENSITIVE KRYPTOR CAL

Device Identifier / Identificateur de l'instrument
(Model/Catalog Detail/No de modèle/Catalogue):

Device ID/No de l'instrument: 813304

82591

BRAHMS PCT SENSITIVE KRYPTOR QC

Device Identifier / Identificateur de l'instrument
(Model/Catalog Detail/No de modèle/Catalogue):

Device ID/No de l'instrument: 813305

82592

BRAHMS CGA II KRYPTOR

Device Identifier / Identificateur de l'instrument
(Model/Catalog Detail/No de modèle/Catalogue):

Device ID/No de l'instrument: 815670

839.050

BRAHMS CGA II KRYPTOR CAL

Device Identifier / Identificateur de l'instrument
(Model/Catalog Detail/No de modèle/Catalogue):

Device ID/No de l'instrument: 815671

LN/NH: 96541

Santé Health
Canada Canada

Therapeutic Products Directorate
Medical Devices Bureau
Direction des produits thérapeutiques
Bureau des matériels médicaux

Application Number:
Numéro de la demande:

263153

Page 2

Manufacturer ID:
Identificateur du fabricant:

116875

83991

BRAHMS CGA II KRYPTOR QC

Device Identifier / Identificateur de l'instrument
(Model/Catalog Detail/No de modèle/Catalogue):

Device ID/No de l'instrument: 815672

83992

BRAHMS ANTI-TGN KRYPTOR

Device Identifier / Identificateur de l'instrument
(Model/Catalog Detail/No de modèle/Catalogue):

Device ID/No de l'instrument: 823274

830.075

BRAHMS ANTI-TGN KRYPTOR CAL

Device Identifier / Identificateur de l'instrument
(Model/Catalog Detail/No de modèle/Catalogue):

Device ID/No de l'instrument: 823275

83091

BRAHMS ANTI-TGN/-TPON KRYPTOR QC

Device Identifier / Identificateur de l'instrument
(Model/Catalog Detail/No de modèle/Catalogue):

Device ID/No de l'instrument: 823276

85392

BRAHMS ANTI-TPON KRYPTOR

Device Identifier / Identificateur de l'instrument
(Model/Catalog Detail/No de modèle/Catalogue):

Device ID/No de l'instrument: 823277

852.075

BRAHMS ANTI-TPON KRYPTOR CAL

Device Identifier / Identificateur de l'instrument
(Model/Catalog Detail/No de modèle/Catalogue):

Device ID/No de l'instrument: 823278

85291

LN/NH: 96541

Santé Health
Canada Canada

Therapeutic Products Directorate
Medical Devices Bureau
Direction des produits thérapeutiques
Bureau des matériels médicaux

Application Number:
Numéro de la demande:

263153

Page 3

Manufacturer ID:
Identificateur du fabricant:

116875

BRAHMS HTG SENSITIVE KRYPTOR

Device Identifier / Identificateur de l'instrument
(Model/Catalog Detail/No de modèle/Catalogue):

Device ID/No de l'instrument: 823279

832.075

BRAHMS HTG SENSITIVE KRYPTOR CAL

Device Identifier / Identificateur de l'instrument
(Model/Catalog Detail/No de modèle/Catalogue):

Device ID/No de l'instrument: 823280

83291

BRAHMS HTG SENSITIVE KRYPTOR QC

Device Identifier / Identificateur de l'instrument
(Model/Catalog Detail/No de modèle/Catalogue):

Device ID/No de l'instrument: 823281

83292

BRAHMS TRAK HUMAN KRYPTOR

Device Identifier / Identificateur de l'instrument
(Model/Catalog Detail/No de modèle/Catalogue):

Device ID/No de l'instrument: 823282

801.050

BRAHMS TRAK HUMAN KRYPTOR CAL

Device Identifier / Identificateur de l'instrument
(Model/Catalog Detail/No de modèle/Catalogue):

Device ID/No de l'instrument: 823283

80191

BRAHMS TRAK HUMAN KRYPTOR QC

Device Identifier / Identificateur de l'instrument
(Model/Catalog Detail/No de modèle/Catalogue):

Device ID/No de l'instrument: 823284

80192

LN/NH: 96541

Santé Health
Canada Canada

Therapeutic Products Directorate
Medical Devices Bureau
Direction des produits thérapeutiques
Bureau des matériels médicaux

Application Number:
Numéro de la demande:

263153

Page 4

Manufacturer ID:
Identificateur du fabricant:

116875

B'R'A'H'M'S

Aktiengesellschaft

510(k)

Premarket

Notification

B'R'A'H'M'S

PCT

sensitive

KRYPTOR

Test

System

Section

5.0,

510(k)

Summary

Page

1

of

6

510(k)

SUMMARYZo

General

Information

MAR

3

1

2008

Submitted

by:

B.R-A.H.M.S

Aktiengesellschafi

Neuendorfstrasse

25

D-

16761

Henningsdorf

near

Berlin

Germany

Contact

Person:

Jonas

Leichtner

BR-A.H.M.S

USA,

Inc.

2568A

Riva

Road,

Suite

207

Annapolis,

MD

21401

Phone:

(410)

897

9960

Fax:

(410)

972

2452

Email:

i.leichtnera)brahms-usa.com

Date

Prepared:

February

14,

2008

Device

Name

Trade

Name:

B.R.A.H.M.S

PCT

sensitive

KRYPTOR®

Test

System

Common

Name:

Inflammatory

Response

Marker

Classification

Name:

Antigen,

Inflammatory

Response

Marker,

Sepsis,

21

CFR

866.3210

Predicate

Device

Manufacturer

Product

Name

510(k)

No.

BR.A.H.M.S

Aktiengesellschaft

B-R.A.H.M.S

PCT

LIA

K040887

Device

Description

The

BR.A.H-M-S

PCT

sensitive

KRYPTOR®

assay

is

a

homogeneous

sandwich

immunoassay

for

detection

of

PCT

in

human

serum

or

plasma.

The

B-R.A.H.M.S

KRYPTOR®

analyzer

is a fully

automated

system.

The

B.R.A.H-M'S

KRYPTOR®

analyzer

is

a

closed

system

and

can

only

operate

utilizing

special

reagents

provided

by

B.R.A-H-M.S

Aktiengesellschaft.

The

measuring

principle

is

based

on

Time-

Resolved

Amplified

Cryptate

Emission

(TRACE®)

technology,

which

measures

the

signal

that

is

emitted

from

an

immunocomplex

with

time

delay.

B'R'A'H'M'S

Aktiengesellschaft

510(k)

Premarket

Notification

B'R'A'H'M'S

PCT

sensitive

KRYPTOR

®

Test

System

Section

5.0,

510(k)

Summary

Page

2

of

6

The

basis

of

the

TRACE®

technology

is

a

non-radiative

energy

transfer

from

a

donor

[a

cage-like

structure

with

a

europium

ion

in

the

center

(cryptate)]

to

an

acceptor

(XL

665).

The

proximity

of

donor

(cryptate)

and

acceptor

(XL

665)

in

a

formed

immunocomplex

and

the

spectral

overlap

between

donor

emission

and

acceptor

absorption

spectra

on

the

one

hand

intensifies

the

fluorescent

signal

and

on

the

other

hand

extends

the

life

span

of

the

acceptor

signal,

allowing

for

the

measurement

of

temporally

delayed

fluorescence.

After

the

sample

to

be

measured

has

been

excited

with

a

nitrogen

laser

at

337

nm, the

donor

(cryptate)

emits

a

long-life

fluorescent

signal

in

the

milli-second

range

at

620

nm,

while

the

acceptor

(XL

665)

generates

a

short-life

signal

in the

range

of

nano-

seconds

at

665

nm.

When

both

components

are

bound

in

an

immunocomplex,

both

the

signal

amplification

and

the

prolonged

life

span

of

the

acceptor

signal

occur

at

665

nm,

and

the life

is

in

the

microsecond

range.

This

delayed

acceptor

signal

is

proportional

to

the

concentration

of

the analyte

to

be

measured.

The

specific

fluorescence

which

is

proportional

to

the

antigen

concentration

is

obtained

through

a

double

selection:

spectral

(separation

depending

on

wave-length)

and

temporal

(time

resolved

measurement).

This

enables

an

exclusive

measurement

of

the signal

emitted

by

the

immunological

complex

and

the

ratio

between

the

two

wave-lengths

(665/620)

allows

a

real-time

correction

of

the

variations

in

optic

transmission

from

the

medium.

The

contents

of

the

BR.A.H.M.S

PCT

sensitive

KRYPTOR

assay

are:

Quantity

for

50

Reagent

deemntos

Content

determinations

Cryptate

1

bottle

Cryptate

conjugate,

cryptate

labeled,

Conjugate

lyophilized

anti-PCT

antibody

(polyclonal,

sheep),

3.2

ml

after

reconstitution

with

KRYPTOR®

Solution

1

and

KRYPTOR®

Solution

2

XL665

1

bottle

XL665

conjugate,

XL665

labeled,

Conjugate

lyophilized

anti-PCT

antibody

(monoclonal,

mouse),

3.95

ml

after

reconstitution

with

KRYPTOR®

Solution

1

and

KRYPTOR®

Solution

2

Diluent

1

bottle

Defibrinated

human

plasma,

for

diluting

samples

above

50

ng/ml,

ready

to

use

Controls,

Calibrator,

and

Consumables

are

provided

separate

from

the

reagent

unit.

B'R'A'H'M'S

Aktiengesellschaft

510(k)

Premarket

Notification

B.R.A.H'M'S

PCT

sensitive

KRYPTOR®

Test

System

Section

5.0,

510(k)

Summary

Page

3

of

6

Intended

Use

The

B.R-A'H'M'S

PCT

sensitive

KRYPTOR®

is

an

immunofluorescent

assay

used

to

determine

the

concentration

of

PCT

(procalcitonin)

in

human

serum

and

plasma.

The

B.R.A.H.M.S

PCT

sensitive

KRYPTOR®

is

intended

for

use

in

conjunction

with

other

laboratory

findings

and

clinical

assessments

to

aid

in

the

risk

assessment

of

critically

ill

patients

on

their

first

day

of

ICU

admission

for

progression

to

severe

sepsis

and

septic

shock.

Technological

Comparison

The

B.R.A.H-M.S

PCT

sensitive

KRYPTOR®

and the

B.R.A.H.M.S

PCT

LIA

have

similar

indications

for

use,

are

quantitative

assays,

and

are

used

to

determine

the

concentration

of

PCT

in

human

serum

and

plasma

The

devices

utilize

different

technologies

and

instruments

to

obtain

the

results.

TRACE®

technology

(immunofluorescence)

is

used

with

the

B.R.A.H-M-S

KRYPTOR®

analyzer

and

chemiluminescence

is

used with

a

luminometer

for

BRA-H'M'S

PCT

LIA.

Each

device

uses

2

antibodies,

one

of

which

is

the

same

for

both

devices.

The

monoclonal

antibody

used

in

both

devices

binds

to

Katacalcin.

For

the

second

antibody,

the

B-R'A'H'M'S

PCT sensitive

KRYPTOR®

uses

a

polyclonal

antibody,

which

is

directed

against

Calcitonin.

The

B.R.A-H-M.S

PCT

LIA

uses

a

monoclonal

antibody

directed

against Calcitonin

instead

of a polyclonal

antibody.

Although

the antibodies

directed

against

Calcitonin

come

from

different

origin

they

bind

to

the

same

epitopes.

Therefore

they

will

bind

to the

same

PCT

molecule.

Performance

Summary

Precision

and

Reproducibility

Based

on

CLSI testing,

the

analytical

sensitivity

was

determined

to

be

0.02

ng/ml

and

the

functional

assay

sensitivity

(FAS)

was

determined

to

be

0.06

ng/ml.

In

addition,

the

total

precision

ranges

from

3.2 -13.4

%

CV

and

the

within

run

precision

ranges

from

1.0

-

13.6 % CV.

High

Dose Hook

Effect

The

B.R.AoH.M.S

PCT

sensitive

KRYPTOR®

assay

is

homogenous,

and

does

not

require

separation

or

washing

steps.

It

is

thus

possible

to

obtain

data

without

interrupting

the

immunological

reaction.

High

concentration

samples

(>

50

ng/ml)

are

detected

in

the

first

few

seconds

of

incubation

and

may

be

diluted

by

the appropriate

dilution

factor,

then

re-assayed

automatically.

This

process

allows

for

sample

measurements

greater

than

50

ng/ml

up

to

5000

ng/ml.

B'R'A'H'M'S

Aktiengesellschaft

510(k)

Premarket

Notification

B.R.AH'M'S

PCT

sensitive

KRYPTOR®

Test

System

Section

5.0,

510(k)

Summary

Page

4

of

6

Interference

and

Cross

Reactivity

Based

on

CLSI

testing,

the

substances

evaluated

with

the

B.R.A.H.M.S

PCT

sensitive

KRYPTOR®

assay

were

found

not

to

affect

the

test

performance

at

concentrations

reasonably

and

consistently

found

in

clinical

situations.

The

substances

included

the

following
*

bilirubin,

*

hemoglobin,

*

triglycerides,

*

albumin,

•

substances

that

share

amino

acid

sequences

with

procalcitonin,

*

drugs

which

are

typically

used

for

septic

patients

in

intensive

care

units,

and

*

drugs

which

may

be

commonly

used

in

subjects

at

greater

risk

of

developing

community

acquired

pneumonia

than

the

general

population,

such

as

in

asthma

and/or

COPD

patients.

Method

Comparison

Summary

The

B.R.A.H.M.S

PCT

sensitive

KRYPTOR®

and the

B.R.A.H.M.S

PCT

LIA

both

detect

procalcitonin

(PCT)

in

human

serum

or

plasma.

A

correlation

study

was

performed

in

accordance

with

CLSI

guideline

EP9-A,

"Method

Comparison

and

Bias

Estimation

Using

Patient

Samples"

between

the

B-R'A'H'M'S

PCT

sensitive

KRYPTOR®

assay

and

the

B.R.A.H-M-S

PCT

LIA

assay.

There

were

184

samples

from

three

(3)

sites,

which

had

B.R-A.H.M.S

PCT

LIA

measurements

of

0.3

ng/ml

(the

functional

assay

sensitivity

of

13BR.A.H.MS

PCT

LIA)

or

higher

and/or

B.R.A.H-M.S

PCT

sensitive

KRYPTOR®

measurements

of

0.06

ng/ml

(the

functional

assay

sensitivity

of

B-R'A'H'M'S

PCT

sensitive

KRYPTOR®)

or

higher.

Passing-Bablock

analysis

shows

a

nearly

perfect

correlation

of

the

B-R-A.H.M.S

PCT

sensitive

KRYPTOR®

assay

and

B.R.A-H.M.S

PCT

LIA

assay,

as

demonstrated

in

the

correlation

graph

below.

B'R'A'H'M'S

Aktiengesellschafi

510(k)

Premarket

Notification

B'R.A-H'M'S

PCT

sensitive

KRYPTOR®

Test

System

Section

5.0,

510(k)

Summary

Page

5

of

6

300

250

0~~~~~~~~~~~~~~~~~~~

¢-'

>-200-

250

-

-

0

-~~~~~~~~~~~~

>

1

00

./

-

//-

·

~ ~ ~ ~ ~ ~ ~

~ ~ ~

I

~~~~~~o

50-

y=

0.95x

+

0.03

r~0.98

0~~~~~~~~~

Oe~~~https://manualmachine.com/

100

100

150

200

250

300

B.RAoH. M.$

PCT

LIA

Interpretation

of

Results

The

B.R.A.H-M.S

PCT

sensitive

KRYPTOR

®

is

intended

to

aid

in

the

risk

assessment

of

critically

ill

patients

on

their

first

day

of

ICU

admission

for

progression

to

severe

sepsis

and

septic

shock.

SIRS,

Sepsis,

Severe

Sepsis,

and

Septic

Shock

were

categorized

according

to

the

criteria

of

the

consensus

conference

of

the

American

College

of

Chest

Physicians/Society

of

Critical

Care

Medicine.

PCT

should

always

be

interpreted

in

the

clinical

context

of

the

patient.

Therefore,

clinicians

should

use

the

PCT

results

in

conjunction

with

other

laboratory

findings

and

clinical

signs

of

the

patient.

Data

support

the

following

interpretative

risk

assessment

criteria:

PCT

> 2 ng/ml

PCT

levels

above

2.0

ng/ml

on

the

first

day

of

ICU

admission

represent

a

high

risk

for

progression

to

severe

sepsis

and/or

septic

shock.

PCT

<

0.5

ng/ml

PCT

levels

below

0.5

ng/ml

on

the:

first

day

of

ICU

admission

represent

a

low

risk

for

progression

to

severe

sepsis

and/or

septic

shock.

B.R.A'H'M'S

Aktiengesellschaft

5

10(k)

Premarket

Notification

B.R.A.H'M'S

PCT

sensitive

KRYPTOR®

Test

System

Section

5.0,

510(k)

Summary

Page

6

of

6

Note:

PCT

levels

below

0.5

ng/ml

do

not

exclude

an

infection,

because

localized

infections

(without

systemic

signs)

may

also

be

associated

with

such

low levels.

If

the

PCT

measurement

is

done

very

early

after

the

systemic

infection

process

has

started

(usually

<

6

hours),

these

values

may

still

be

low.

As

various

non-infectious

conditions

are

known

to

induce

PCT

as

well,

PCT

levels

between

0.5

ng/ml

and

2.0

ng/ml

should

be

reviewed

carefully

to

take

into

account

the

specific

clinical

background

and

condition(s)

of

the

individual

patient.

Expected

Values

In

normal

subjects,

PCT

concentrations

are

<

0.1

ng/ml.

In

a

population

of

151

subjects,

146

had

a

PCT

value

<

0.1

ng/ml.

Specimen

Collection

and

Handling

Serum

or

plasma

may

be

used.

B-R-A.HM.S

recommends

the

use

of

only

one

matrix,

i.e.,

use

the

same

material

(either

serum

or

plasma

[EDTA

or

heparin])

throughout

the

patient's

clinical

course.

It

is

recommended

that

citrate

plasma

not

be

used,

since

concentrations

were

underestimated

with

citrate

plasma.

CLSI

guidelines

should

be

followed

for

collecting,

transporting,

and

processing

patient

samples.

The

sample

volume

needed

for

an

assay

is

50

PI.

Testing

demonstrated

that

there

is

no

difference

between

the

use

of

glass

and

plastic

collecting

tube

types

and

that filling

volume

has

no

impact

on

the

result.

In

any

case,

the

results

of

the

BR.A.H.M.S

PCT

sensitive

KRYPTOR®

assay

should

be

evaluated

in

context

of

all

laboratory

findings

and

the

total

clinical

status

of

the

patient.

In

cases

where

the

laboratory

results

do

not

agree

with

the

clinical

picture

or

history,

additional

tests

should

be

performed.

Samples

may

be

stored

up

to

5

days

at

:2

-

80C.

Samples

may

be

frozen

(-20

0

C)

and

thawed

four

times.

Conclusions

The

BR.A.H.M.S

PCT

sensitive

KRYPTOR®

Test

System

is

substantially

equivalent

to

legally

marketed

Inflammatory

Response

Markers.

DEPARTMENT

OF

HEALTH

&

HUMAN

SERVICES

Public

Health

Service

Food

and

Drug

Administration

2098

Gaither

Road

Rockville

MD

20850

Mr.

Jonas

Leichtner

Director

of

Marketing

BR.A.H.M.S

Aktiengelsellschaft

2568A

Riva

Road,

Suite

207

Annapolis,

MD

21401

Re:

K070310
Trade/Device

Name:

BR.A.H.M-S

PCT

sensitive

KRYPTOR®

Test

System

Regulation

Number:

21

CFR

866.3210

Regulation

Name:

Antigen,

Inflammatory

Response

Marker,

Sepsis

Regulatory

Class:

Class

II

Product

Code:

NTM

Dated:

February

20,

2008

Received:

February

20,

2008

Dear

Mr.

Leichtner:

We

have

reviewed

your

Section

5

10(k)

premarket

notification

of

intent

to

market

the

device

referenced

above

and

have

determined

the

device

is

substantially

equivalent

(for

the

indications

for use

stated

in

the

enclosure)

to

legally

marketed

predicate

devices

marketed

in

interstate

commerce

prior

to

May

28,

1976,

the

enactment

date

of

the

Medical

Device

Amendments,

or

to

devices

that

have

been

reclassified

in

accordance

with

the

provisions

of

the

Federal

Food,

Drug,

and

Cosmetic

Act

(Act)

that

do

not

require

approval

of

a

premarket

approval

application

(PMA).

You

may,

therefore,

market

the

device,

subject

to

the

general

controls

provisions

of

the

Act.

The

general

controls

provisions

of

the

Act

include

requirements

for

annual

registration,

listing

of

devices,

good

manufacturing

practice,

labeling,

and

prohibitions

against

misbranding

and

adulteration.
If

your

device

is

classified

(see

above)

into

either

class

II

(Special

Controls)

or class

III

(PMA),

it

may

be

subject

to

such

additional

controls.

Existing

major

regulations

affecting

your

device

can

be

found

in

Title

21,

Code

of

Federal

Regulations

(CFR),

Parts

800

to

895.

In

addition,

FDA

may

publish

further

announcements

concerning

your

device

in

the

Federal

Register.

Please

be

advised

that

FDA's

issuance

of

a

substantial

equivalence

determination

does

not

mean

that

FDA

has

made

a

determination

that

your

device

complies

with

other

requirements

of

the

Act

or

any

Federal

statutes

and

regulations

administered

by

other

Federal

agencies.

You

must

comply

with

all

the

Act's

requirements,

including,

but

not

limited

to:

registration

and

listing

(21

CFR

Part

807);

labeling

(21

CFR

Parts

801

and

809);

and

good

manufacturing

practice

requirements

as

set

forth

in

the

quality

systems

(QS)

regulation

(21

CFR

Part

820).

This

letter

will

allow

you

to

begin

marketing

your

device

as

described

in

your

Section

510(k)

premarket

notification.

The

FDA

finding

of

substantial

equivalence

of

your

Page

2

-

This

letter

will

allow

you

to

begin

marketing

your

device

as

described

in

your

Section

5

10(k)

premarket

notification.

The

FDA

finding

of

substantial

equivalence

of

your

device

to

a

legally

marketed

predicate

device

results

in

a

classification

for

your

device

and

thus,

permits

your

device

to

proceed

to

the

market.

If

you

desire

specific

advice

for

your

device

on

our

labeling

regulation

(21

CFR

Part

801),

please

contact

the

Office

of

In

Vitro

Diagnostic

Device

Evaluation

and

Safety

at

240-276-0450.

Also,

please

note

the

regulation

entitled,

"Misbranding

by

reference

to

premarket

notification"

(21CFR

Part

807.97).

For

questions

regarding

postmarket

surveillance,

please

contact

CDRH's

Office

of

Surveillance

and

Biometric's

(OSB's)

Division

of

Postmarket

Surveillance

at

240-276-3474.

For

questions

regarding

the

reporting

of

device

adverse:

events

(Medical

Device

Reporting

(MDR)),

please

contact

the

Division

of

Surveillance

Systems

at

240-276-3464.

You

may

obtain

other

general

information

on

your

responsibilities

under

the

Act

from

the

Division

of

Small

Manufacturers,

International

and

Consumer

Assistance

at

its

toll-free

number

(800)

638-2041

or

(240)

276-3150

or

at

its

Internet

address

http://www.fda.gov/cdrh/industrV/support/index.html.

Sincerely

yours,

Sally

A.

Hojvat,

M.Sc.,

Ph.D.

Director

Division

of

Microbiology

Devices

Office

of

In

Vitro

Diagnostic

Device

Evaluation

and

Safety

Center

for

Devices

and

Radiological

Health

Enclosure

INDICATIONS

FOR

USE

510(k)

Number

(if

known):

K070310

Device

Name:

B.R.A.H.M.S

PCT

sensitive

KRYPTOR

®

Test

System

Sponsor

Name:

B-R.A.H.M.S

Aktiengesellschaft

Indications

for

Use:

The

B.R.A.H.M.S

PCT

sensitive

KRYPTOR®

is

designed

for

automated

detection

of

PCT

(procalcitonin)

in

human

serum

or

plasma

(EDTA,

heparin)

samples

by

the

immunofluorescent

B.R.A.H.M.S

PCT

sensitive

KRYPTOR®

assay.

The

B.R.A.H.M.S

PCT

sensitive

KRYPTOR®

is

intended

for

use

in

conjunction

with

other

laboratory

findings

and

clinical

assessments

to

aid

in

the

risk

assessment

of

critically

ill

patients

on

their

first

day

of

ICU

admission

for

progression

to

severe

sepsis

and

septic

shock.

Prescription

Use

[

And/Or

Over-The-Counter

Use

[_

(21

CFR

801

Subpart

D)

(21

CFR

807

Subpart

C)

Do

Not

Write

Below

This

Line-

Continue

on

Another

Page

if

Needed

Concurrence

of

CDRH,

Office

of

In

Vitro

Diagnostic

Devices

(OIVD)

Diasin

Sign-O

Office

of

In

Vitro

Diagnostic

Device

Evaluation

and

Safety

SIA~k

v

Australian Register of Therapeutic Goods Certificate

Issued to

Microgenics Diagnostics Pty Ltd

for approval to supply

Instrument/analyser IVDs

ARTG Identifier 190292 Class 1

ARTG Start date 7/10/2011

Product Category: Medical Device Included - IVD Class 1

GMDN CT943

GMDN Term Instrument/analyser IVDs

Intended Purpose Instruments / Analysers used as an in vitro diagnostic medical device

(IVD) for the purposes of processing, examining and/or providing
information about a clinical specimen.

Manufacturer Details Address Certificate number(s)

Brahms GmbH Neuendorfstrasse 25

Hennigsdorf, , 16761
Germany

ARTG Standard Conditions

The above Medical Device Included - IVD Class 1 has been entered on the Register subject to the
following conditions:

· The automatic conditions applicable to the inclusion of all kinds of medical devices in the Register are
as specified in section 41FN of the Therapeutic Goods Act 1989.

· The standard conditions that are imposed under section 41FO of the Therapeutic Goods Act 1989
when kinds of medical devices are included in the Register are as set out in the following paragraphs.

· For a medical device included in the Register under Chapter 4 and imported into Australia, the Sponsor
must ensure that information about the Sponsor is provided in such a way as to allow the sponsor to be
identified.

· Each sponsor shall retain records of the distribution of all of the sponsor's medical devices included in
the Register under Chapter 4. In the case of records relating to a Class AIMD medical device, Class III
medical device, or Class IIb medical device that is an implantable medical device, the distribution
records shall be retained for a minimum period of 10 years. In the case of records relating to any other
device, the distribution records shall be retained for a minimum period of 5 years.

· The sponsor of a medical device included in the Register under Chapter 4 shall keep an up to date log
of information of the kind specified in Regulation 5.8.

· A sponsor shall ensure that a medical device within their control is stored and transported in
accordance with the instructions and information provided by the manufacturer.

· It is a condition of inclusion in the ARTG that the sponsor of a medical device that is a Class 4 IVD
provides three consecutive annual reports to the Head of the Office of Devices Authorisation,
Therapeutic Goods Administration following inclusion of the device in the ARTG. (as specified in 5.8 of
the regulations) Annual reports are due on 1 October each year. Reports should be for the period 1 July
to 30 June. The first report following the date of inclusion in the ARTG must be for a period of at least
six months but no longer than 18 months. Subsequent reports are to be provided on 1 October for a
further 2 years. The annual report must include all complaints received by the manufacturer relating to
problems with the use of the device that have been received by them over the year.

· Goods which would require an application audit under Regulation 5.3 if subject to a separate
application for entry in the Register cannot be included under this ARTG entry until a request to vary the
entry has been submitted and approved by the TGA.

Products covered by this Entry

1. Instrument/analyser IVDs

This entry: does not contain System(s)/Procedure Pack(s)

Product Specific Conditions

No specific conditions have been recorded against this entry.

Therapeutic Goods Administration
PO Box 100, Woden ACT 2606 Australia
Phone: [phone]
Email: [e-mail]

ARTG Identifier: 190292
ARTG Start Date: 7/10/2011