Blood Glucose Test Strips
ACON
REF G133-111, REF G133-112, REF G133-114,
REF G133-118, REF G133-119, REF G133-211
Package Insert
PRINCIPLE AND INTENDED USE
The On Call® Plus Blood Glucose Test Strips are thin strips with a chemical reagent
system. They work with the On Call® Plus and On Call® EZ Blood Glucose Meters to
measure the glucose concentration in whole blood. Blood is applied to the end tip of
the test strip, then automatically absorbed into the reaction cell where the reaction
takes place. A transient electrical current is formed during the reaction and the blood
glucose concentration is calculated based on the electrical current detected by the
meter, then the result is shown on the meter display. The meters are calibrated to
display plasma-like concentration results.
For in vitro diagnostic use. Test strips are to be used only outside the body for testing
purposes. For self-testing and professional use.
COMPOSITION
Each test strip contains the following reactive chemicals: Glucose oxidase < 25 IU,
Mediator < 300 μg.
Each test strip vial contains a drying agent.
STORAGE AND HANDLING
• Store test strips in a cool, dry place at room temperature, 15-30°C (59-86°F). Store
them away from heat and direct sunlight.
• Do not freeze or refrigerate.
• To ensure accurate results, use the test strips at room temperature.
• Do not store the test strips outside their protective vial. Test strips must be stored in
the original vial with the cap tightly closed.
• Do not store or use the test strips in a humid place such as a bathroom.
• Do not store the meter, the test strips or control solution near bleach or cleaners
that contain bleach.
• Do not transfer the test strips to a new vial or any other container.
• Replace the vial cap immediately after removing a test strip.
• Use the test strip immediately after removing it from the vial.
• Do not use your test strips past the unopened expiration date printed on the vial.
Using test strips past the expiration date may produce incorrect test results.
Note: All expiration dates are printed in Year-Month format. 2012-01 means
January 2012.
• Use a new vial of test strips for only 3 months after opening. The opened vial
expiration date is 3 months after the vial was first opened. Write the opened vial
expiration date on the vial label after you open it.
PRECAUTIONS
• For in vitro diagnostic use. The test strips are to be used only outside the body for
testing purposes.
• Do not use test strips after the expiration date shown on the vial. Expired test strips
may give incorrect blood glucose readings.
• Do not use test strips that are torn, bent, or damaged in any way. Do not reuse test strips.
• The sample must only be applied to the tip of the test strip. Do not apply blood or
control solution to the top of the test strip as this may result in an inaccurate reading.
• Before running a blood glucose test, make sure that the code chip contained with
that vial of strips is inserted into the code chip slot on the right side of the meter.
• Discard the vial and any unused test strips 3 months after you first open it. Constant
exposure to air may destroy chemicals in the test strip. This damage can cause
incorrect readings.
• Keep the test strip vial away from children and animals.
• Consult your physician or healthcare professional before making any changes in
our treatment plan based on your blood glucose test results.
MATERIALS PROVIDED
• Test Strips • Code Chip • Package Insert
MATERIALS REQUIRED BUT NOT PROVIDED
• Meter • Sterile Lancets • Lancing Device • Control Solution
INSTRUCTIONS FOR USE
See your User's Manual for complete instructions for blood sample collection before use.
1. Open the cap of the test strip vial only to remove a test strip for testing. Replace the
cap immediately to protect the remaining test strips from moisture in the air.
2. Run the blood glucose test following the instructions contained in your User's Manual.
3. The blood glucose test result will be shown on the meter display window. This result should
fall within the target range recommended by your healthcare professional. If your blood
glucose test results are higher or lower, ask your healthcare professional what to do. Always
consult your healthcare professional before making any changes to your treatment plan.
IMPORTANT: On Call® Plus and On Call® EZ Blood Glucose Monitoring Systems
allows alternative site testing for forearm and palm testing in additional to fingertip
testing. There are important differences between forearm, palm and fingertip samples
that you should know. Important information about forearm and palm glucose testing:
• When blood levels are changing rapidly such as after a meal, insulin dose or
exercise, blood from the fingertips may show these changes more rapidly than
blood from other areas.
• Fingertips should be used if testing is within 2 hours of a meal, insulin dose or
exercise and any time you feel glucose levels are changing rapidly.
• You should test with the fingertips anytime there is a concern for hypoglycemia or
you suffer from hypoglycemia unawareness.
English
Blood glucose monitoring requires the help of a healthcare professional. Together you
can set your own range of expected blood glucose values, arrange your testing times,
and discuss the meaning of your blood glucose results.
Expected blood glucose levels for people without diabetes:1
Time Range, mg/dL Range, mmol/L
Fasting and Before Meals 70 – 100 3.9 – 6.1
2 Hours After Meal Less than 140 Less than 7.8
CHECKING THE SYSTEM
RANGE OF EXPECTED VALUES
Your blood glucose meter must be handled carefully. See your User's Manual for detailed
instructions for meter care. The quality control test shou ld be used to check that the meter
and test strips are working together properly. Follow the test procedure in your User's
Manual to run a quality control test. Two ranges CTRL 1 and CTRL 2 are shown on the test
strip vial label (or on the foil pouch). Control Solution 1 is sufficient for most all self-testing
needs. If you think your meter or strips may not be working correctly, you may also want to
do a level 2 test. Contact your dealer for information on purchasing control solution.
For confirmation of results, Control Solution 1 tests should fall within the CTRL 1 range, and
Control Solution 2 tes ts should fall within the CTRL 2 range. W hen testing with Cont rol
Solution 1, make sure you are matching the results to the CTRL 1 range on the vial label.
CAUTION: If your quality control test result falls outside the control range shown on
the test strip vial, DO NOT use the system to test your blood, as the system may not be
working properly. If you cannot correct the problem, contact your dealer for help.
LIMITATIONS
• The On Call® Plus and On Call® EZ meters, test strips and other components of the
On Call® Plus and On Call® EZ Blood Glucose Monitoring Systems have been
designed, tested and proven to work together effectively to provide accurate blood
glucose measurements. Do not use components from other brands.
• Use only with whole blood. Do not use with serum or plasma samples.
• Do not use for testing newborns.
• Very high (above 55%) and very low (below 30%) hematocrit levels can cause false
results. Talk to your healthcare professional to find out your hematocrit level.
• Abnormally high levels of vitamin C and other reducing substances will produce
false high blood glucose measurements.
• The system is tested to accurately read the measurement of glucose in whole blood
within the range of 1.1-33.3 mmol/L (20 to 600 mg/dL).
• Fatty substances (triglycerides up to 166.7 mmol/L (3,000 mg/dL) or cholesterol up
to 27.7 mmol/L (500 mg/dL) have no major effect on blood glucose test results.
• The On Call® Plus Blood Glucose Monitoring System has been tested and shown to
work properly up to 10,000ft (3,048 meters).
• Severely ill persons should not run the glucose test with the On Call® Plus Blood
Glucose Monitoring System.
• Dispose of blood samples and materials carefully. Treat all blood samples as if they
are infectious materials. Follow proper precautions and obey all local regulations
when disposing of materials.
PERFORMANCE CHARACTERISTICS
The On Call® Plus and On Call® EZ meters are calibrated by using YSI (Model 2300
STAT PLUS) Glucose Analyzer reference instrument, which is traceable to NIST
reference standard.
Reproducibility, Precision
Ten replicate assays were each run on ten On Call® Plus Blood Glucose Meters.
Heparinized venous blood samples at five concentration levels were used in the testing.
The results provided the following reproducibility, precision estimates.
MEAN
Standard Deviation
(mg/dL) or Coefficient of
Variation (CV)
Intermediate Precision
Ten replicate assays drawn from 3 strip lots were run on ten On Call® Plus Blood
Glucose Meters each day for a total of 10 days. Control solutions at three
concentration levels were used in the testing. The results provided the following
intermediate precision estimates.
# MEAN
Strip Lot 1
Strip Lot 2
Strip Lot 3
System Accuracy
The capillary blood glucose measurements from 107 participants were taken by a
trained technician using the On Call® Plus Blood Glucose Meter (y). Capillary blood
2.6 mmol/L
(46 mg/dL)
mmol/L (2.5
2.4 mmol/L (43 mg/dL) 0.11 mmol/L (1.9 mg/dL)
7.5 mmol/L (136 mg/dL) 3.7% (CV)
20.2 mmol/L (363 mg/dL) 3.3% (CV)
2.1 mmol/L (37 mg/dL) 0.12 mmol/L (2.2 mg/dL)
7.2 mmol/L (129 mg/dL) 3.7% (CV)
19.4 mmol/L (349 mg/dL) 3.8% (CV)
2.2 mmol/L (39 mg/dL) 0.11 mmol/L (1.9 mg/dL)
7.3 mmol/L (131 mg/dL) 4.3% (CV)
20.6 mmol/L (370 mg/dL) 2.8% (CV)
0.14
mg/dL)
4.4 mmol/L
(79 mg/dL)
8.3 mmol/L
(149 mg/dL)
3.30% 3.00% 3.10% 2.40%
13.6 mmol/L
(244 mg/dL)
Standard Deviation (mg/dL) or
Coefficient of Variation (CV)
21.1 mmol/L
(380 mg/dL)
samples were obtained from fingertip, palm and forearm sampling sites for the On
®
Call
Plus Blood Glucose Meter testing. Fingertip samples from the same subjects
were also analyzed with YSI Model 2300 STAT PLUS Glucose Analyzer (x). The
results were compared.
Linear Regression Results: On Call® Plus (y) vs. YSI Reference (x)
Sample Site Slope Intercept (mmol/L) / (mg/dL) R N
Fingertip
Palm
Forearm
Fingertip samples were used for YSI reference measurement.
The sample range was 2.4 to 26.3 mmol/L (43 to 473 mg/dL) for On Call® Plus Blood
Glucose Meter testing with blood sampled from fingertip sites. The sample range was
2.6 to 22.2 mmol/L (47 to 399 mg/dL) for On Call® Plus Blood Glucose Meter testing
with blood sampled from palm and forearm sites.
Fingertip Site: System Accuracy Results for Glucose C oncentration ≥ 4.17mmol/L (75mg/dL)
Within ± 5% Within ± 10% Within ± 15% Within ± 20%
97/208 (46.6%) 159/208 (76.4%) 194/208 (93.3%) 208/208 ( 100%)
Fingertip Site: System Accuracy Results for Glucose Conc entration < 4.17mmol/L (75mg/dL)
Within ± 0.28 mmol/L
11/36 (30.6%) 29/36 (80.6%) 36/36 (100%)
Palm Site: System Accuracy Results for Glucose Concentr ation ≥4.17mmol/L (75mg/dL)
Within ± 5% Within ± 10% Within ± 15% Within ± 20%
88/198 (44.4%) 144/198 (72.7%) 187/198 (94.4%) 197/198 (99.5%)
Palm Site: System Accuracy Results for Glucose Concentr ation < 4.17mmol/L (75mg/dL)
Within ± 0.28 mm ol/L
10/16 (62.5%) 16/16 ( 100.0%) 16/16 (100.0%)
Forearm Site: System Accuracy Results for Glucose C oncentration ≥ 4.17mmol/L (75mg/dL)
Within ± 5% Within ± 10% Within ± 15% W ithin ± 20%
73/198 (36.9%)
Forearm Site: System Accuracy Results for Glucose Conc entration < 4.17mmol/L (75mg/dL)
Within ± 0.28 mm ol/L
14/16 (87.5%) 16/16 ( 100.0%) 16/16 (100.0%)
Consumer Study
A consumer study was performed by testing three test strip lots. Participants and a
trained technician used the On Call® Plus Blood Glucose Monitoring System. This
study showed that the patient can run the test as well as the trained technician.
On Call® Plus tests: Linear regression of Participant (y) versus YSI Reference value and
Strip Lot Tested By Slope Intercept (mmol/L) / (mg/dL) R N
Lot 1 Layperson
Lot 1 Technician
Lot 2 Layperson
Lot 2 Technician
Lot 3 Layperson
Lot 3 Technician
For complete instructions, please refer to the User's Manual included with your meter.
For additional questions or issues with this product, please contact your dealer for
help.
1. ADA Clinical Practice Recommendations, 2011.
Number: 1150349904
Effective Date: 2011-10-13
0.9972 -0.2563 / -4.6130 0.9924 244
0.9702 0.1575 / 2.8354 0.9821 214
0.9419 0.3108 / 5.5952 0.9778 214
(5 mg/dL)
(5 mg/dL)
(5 mg/dL)
Linear regression of Technician (y) versus YSI Reference value
Attention, see
instructions for use
For in vitro
diagnostic use only
Store between
15-30°C
Contains sufficient
for <n> tests
Laboratories, Inc.
10125 Mesa Rim Road,
San Diego, CA 92121, USA
Within ± 0.56 mmol/L
(10 mg/dL)
Within ± 0.56 mmol/L
(10 mg/dL)
131/198 (66.2%) 172/198 (86.9%) 197/198 (99.5%)
Within ± 0.56 mmol/L
(10 mg/dL)
0.9881 -0.131 7 / -2.3647 0.9862 214
0.9927 -0.203 3 / -3.6585 0.9857 214
0.9355 0.2520 / 4.5351 0.9867 214
0.9457 0.1492 / 2.6854 0.9851 214
0.9700 0.3296 / 5.9324 0.9827 214
0.9931 0.2300 / 4.1391 0.9843 214
REFERENCES
INDEX OF SYMBOLS
Use by Code Number
Lot Number Control Range
Manufacturer REF Catalog #
Authorized Representative
MDSS GmbH
Schiffgraben 41
30175 Hannover, Germany
Within ± 0.83mmol/L
(15 mg/dL)
Within ± 0.83mmol/L
(15 mg/dL)
Within ± 0.83mmol/L
(15 mg/dL)
0197
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