TRUE METRIX Self Monitoring Blood Glucose Test Strips Instructions for Use

Intended Use

TRUE METRIX® Self Monitoring Blood Glucose Test Strips are intended for use with TRUE METRIX, TRUE METRIX AIR, and TRUE METRIX GO Self Monitoring Blood Glucose Meters to quantitatively measure glucose in fresh, human capillary whole blood from the fingertip. The TRUE METRIX and TRUE METRIX AIR meters are indicated for forearm testing, while the TRUE METRIX GO meter is not. These test strips are designed for single-person use and are intended for self-testing at home (over-the-counter) as an aid in monitoring diabetes control effectiveness. They are not intended for use on neonates or for the diagnosis or screening of diabetes mellitus. Alternative site testing is only recommended during steady-state blood glucose conditions.

Test Principle

The TRUE METRIX Self Monitoring Blood Glucose Test Strip is a plastic strip containing chemicals and electrodes. When inserted into a compatible meter, glucose in the blood sample reacts with the chemicals via an amperometric technology employing a glucose dehydrogenase-FAD reaction. The meter measures the resulting electrical current, corrects for hematocrit and temperature, and displays the glucose result as a plasma value.

Chemical Composition

• Glucose dehydrogenase-FAD (Aspergillus species)
• Mediators
• Buffers
• Stabilizers

Quality Control (QC) Testing

Two quality control tests ensure the system is working properly:

Automatic Self-Test

Performed each time a test strip is inserted into the meter. If all segments appear and the drop symbol is displayed, the meter is functioning correctly.

Control Test

Uses TRUE METRIX Control Solution to check testing technique and system performance. Results should fall within the ranges indicated on the test strip vial label. It is important to perform control tests with more than one level of control solution. For information on obtaining different levels of control solution, contact Trividia Health at 1-800-803-6025 or 1-954-677-4599 (Monday-Friday, 8 AM-8 PM EST).

Blood Glucose Testing

1. Check the opened date and printed date on the test strip vial label. Do not use if past either date or 4 months after opening, whichever comes first. Discard the vial and use a new one.
2. Allow the meter and test strips to acclimate to room temperature for at least 10 minutes. Write the date opened on the vial label when opening for the first time.
3. Wash and dry the area to be lanced.
4. Remove one test strip from the vial and recap the vial immediately.
5. Insert the Contact End of the test strip into the meter's Test Port. The meter will turn on. Do not remove the strip until testing is complete.
6. Obtain a blood drop.
7. With the strip still in the meter, touch the Sample Tip to the top of the blood drop. Allow blood to be drawn into the strip. Remove the Sample Tip from the drop immediately after the meter beeps and dashes appear. If the meter does not start testing within 5 seconds, refer to the Owner's Booklet.
8. The result will be displayed. Record the result.
9. Hold the meter with the test strip pointing down and press the Strip Release Button to discard the used test strip into an appropriate container.

Diagram: Test Strip Insertion

The test strip has a Contact End (labeled 1) that inserts into the meter and a Sample Tip (labeled 2) where the blood sample is applied. The diagram shows the Correct insertion with the Contact End (1) into the meter and the Sample Tip (2) ready for blood, and an Incorrect insertion.

Important Information

• Use TRUE METRIX Self Monitoring Blood Glucose Test Strips only with TRUE METRIX, TRUE METRIX AIR, and TRUE METRIX GO meters and TRUE METRIX Control Solution. Using other meters or controls may yield inaccurate results.
• Test strips are for in vitro diagnostic use only. Do not consume.
• The meter and lancing device are for self-testing and intended for use by one person ONLY. Do not share your meter or lancing device.
• Use fresh, capillary whole blood from the fingertip or forearm*. Do not use venous blood.
• Consult your Doctor or Diabetes Healthcare Professional to determine if forearm testing* is appropriate for you, as results may differ from fingertip results.
• Alternative site testing* should not be used to calibrate continuous blood glucose monitors (CGMs) or for insulin dose calculations.
• Use the fingertip for more accurate results in situations such as: within 2 hours of eating, exercise, or insulin; when blood sugar is rapidly changing; if you are ill or under stress; if forearm test results do not match how you feel; or if you do not notice symptoms of low or high blood sugar.
• NEVER use serum, plasma, or clotted blood for testing.
• *The TRUE METRIX and TRUE METRIX AIR meters are indicated for forearm testing. The TRUE METRIX GO meter is not indicated for forearm testing.

WARNING!

• Upon opening the test strip carton, examine the product for missing, damaged, or broken parts. Ensure the vial cap is securely closed. If damaged or the cap is not closed, DO NOT use the test strips as product may give inaccurate results. Contact Trividia Health Customer Care at 1-800-803-6025 for replacement and assistance.
• NEVER reuse test strips. NEVER wipe test strips with water, alcohol, or any cleaner. DO NOT attempt to remove blood or control solution from test strips or clean and re-use them, as this will cause inaccurate results.
• Use test strips quickly after removing from the vial. Recap the vial immediately. Test strips left outside the vial too long may cause an error message.
• NEVER add a second drop of sample to a test strip. This will cause an error message.
• Discard used test strips and lancets into an appropriate container. Contact with blood presents an infection risk.
• Do not change your treatment plan based on the system's results without consulting your Doctor or Diabetes Healthcare Professional.
• Do not use on neonates.

Caring for Test Strips

• Test strips must be kept in their original vial with the vial cap tightly sealed. NEVER transfer test strips from one vial to another.
• When removing the first test strip, write the date opened on the test strip vial label. Discard all unused test strips in the vial after the date printed next to EXP on the label or 4 months after the date opened, whichever comes first. Using test strips past these dates may cause inaccurate results.
• Store the test strip vial in a dry place at a temperature between 40°F-86°F (4°C-30°C) at 10%-80% relative humidity. DO NOT FREEZE.
• Do not store in the bathroom or kitchen. Do not expose to extreme heat or cold, direct sunlight, or high humidity for extended periods.
• Discard any test strips or vials that appear damaged.
• Do not bend, cut, or alter test strips in any way.

Cleaning and Disinfecting

• TRUE METRIX Self Monitoring Blood Glucose Test Strips, along with the TRUE METRIX, TRUE METRIX AIR, and TRUE METRIX GO meters, are for one-person use ONLY. DO NOT share your meter or lancing device with anyone, including family members.
• All parts of the System (meter, test strips, control solution, lancing device, and lancets) can potentially transmit infectious diseases from bloodborne pathogens, even after cleaning and disinfecting.
• Cleaning and disinfecting the lancing device and the meter destroys most, but not necessarily all, blood-borne pathogens.
• Wash your hands thoroughly with soap and warm water before and after handling the meter, lancing device, lancets, or test strips, as contact with blood presents an infection risk.
• If blood or cleaning solution gets into the test strip vial, discard the vial and use a new one. Contaminated test strips may result in incorrect results or error messages.
• Ensure hands are clean and completely dry before opening the test strip vial, especially if they have been in contact with liquids, particularly blood.
• If a second person assists with testing, the meter and lancing device should be cleaned and disinfected before their use.
• Refer to the TRUE METRIX, TRUE METRIX AIR, or TRUE METRIX GO Self Monitoring System Owner’s Booklets for detailed instructions on cleaning and disinfecting the meter and lancing device.

Limitations

• Do not use during xylose absorption testing, as xylose may produce falsely elevated glucose results. Consult your Doctor before using the system if you are undergoing such tests.
• Ascorbic acid (Vitamin C) at levels greater than normal or therapeutic may cause significant interference, leading to inaccurate results.
• Uric acid can interfere with the device when concentrations exceed 5 mg/dL. For individuals with diabetes, conditions like gout or kidney disease can raise uric acid levels, potentially causing inaccurate glucose results. Consult your Doctor or Diabetes Healthcare Professional if you have concerns.
• Testing at altitudes greater than 10,200 ft may cause inaccurate results.
• Hematocrit levels below 20% or above 70% may cause inaccurate results.
• Critically ill patients should not be tested with this device.
• Inaccurate results may occur in severely hypotensive individuals, dehydrated patients, patients in shock, or those experiencing a hyperglycemic hyperosmolar state (with or without ketosis).
• The TRUE METRIX, TRUE METRIX AIR, or TRUE METRIX GO Self Monitoring Blood Glucose Systems have not been tested with animals; do not use them to test blood glucose on pets.
• Operating Conditions: 41°F-104°F (5°C-40°C), 10%-90% relative humidity.

Expected Results for People Without Diabetes

• Before eating: < 100 mg/dL
• 2 hours after a meal: < 140 mg/dL

A Doctor or Diabetes Healthcare Professional determines personal target glucose ranges. If you experience symptoms suggesting your glucose is too low or too high, contact your Doctor or Diabetes Healthcare Professional immediately.

If comparing TRUE METRIX system results to laboratory results, perform a fingerstick test within 30 minutes of the laboratory test. Results from TRUE METRIX systems may be up to 70 mg/dL higher than venous laboratory results if you have eaten recently.

Troubleshooting

If a result is unusually high or low, or does not match how you feel, perform a Control Test.

If the Control Test is within range:

• Review the Blood Glucose Testing procedure again.
• Recheck your results with a new TRUE METRIX Self Monitoring Blood Glucose Test Strip.

If the results are not within range:

• Check the Use by Dates on the test strip vial or control solution bottle. Do not use if past either date. Test with new strips/control solution.
• Check for error messages and follow the actions described in the Owner’s Booklet.
• Check your testing technique and perform another Control Test.

If results still do not match how you feel, consult your Doctor or Diabetes Healthcare Professional before changing your treatment program.

Performance Characteristics - TRUE METRIX and TRUE METRIX AIR

Accuracy

TRUE METRIX Self Monitoring Blood Glucose System was tested by lay users at a research center and compared to Yellow Springs Instrument (YSI) results.

Fingertip Capillary Blood - < 75 mg/dL (user finger vs. YSI)

Fingertip Capillary Blood - > 75 mg/dL (user finger vs. YSI)

Forearm Capillary Blood - < 75 mg/dL (user forearm vs. YSI)

Forearm Capillary Blood - > 75 mg/dL (user forearm vs. YSI)

Precision

Precision results were performed in a laboratory.

Blood (Within Lot): N=100

Control Solution (Between Day): N=100

Performance Characteristics - TRUE METRIX GO

Accuracy

TRUE METRIX GO Self Monitoring Blood Glucose System was tested by lay users at a research center and compared to Yellow Springs Instrument (YSI) results.

Fingertip Capillary Blood - < 75 mg/dL (user finger vs. YSI)

Fingertip Capillary Blood - > 75 mg/dL (user finger vs. YSI)

Precision

Precision results were performed in a laboratory.

Blood (Within Lot): N=100

Control Solution (Between Day): N=100

Additional Information

For more detailed instructions, refer to the TRUE METRIX, TRUE METRIX AIR, or TRUE METRIX GO Self Monitoring Blood Glucose System Owner’s Booklets. For assistance, call Trividia Health, Inc. toll-free at 1-800-803-6025 (USA) or 1-954-677-4599 (Monday - Friday, 8 AM-8 PM EST). For medical assistance, contact your Doctor or Diabetes Healthcare Professional.

© 03/2021 Trividia Health, Inc. TRUE METRIX and the Trividia Health logo are trademarks of Trividia Health, Inc.

Manufactured by: Trividia Health, Inc., Fort Lauderdale, FL 33309 U.S.A.

Document Reference: RF3TVH03 Rev. 5

References

• U.S. Food and Drug Administration. Blood Glucose Meters, Getting the Most Out of Your Meter. [Electronic Version]. Retrieved December 22, 2009 from http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm109371.htm.
• FDA Public Health Notification: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens: Initial Communication. Available at https://wayback.archive-it.org/7993/20170111013014/http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm224025.htm.
• Infection Prevention during Blood Glucose Monitoring and Insulin Administration. Available at http://www.cdc.gov/injectionsafety/blood-glucose-monitoring.html.
• American Diabetes Association. Classification and Diagnosis of Diabetes. Diabetes Care, Volume 39, Supplement 1, January 2016.
• Larson-Cohn U: Difference between capillary and venous blood glucose during oral glucose tolerance tests. Scand J Clin Lab Invest 36:805-808, 1976.
• Data on file.