The PTS Panels eGLU test strips are intended to be used to quantitatively measure glucose in whole blood. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders. The PTS Panels eGLU test strips are for in vitro diagnostic use. The PTS Panels eGLU test strips are currently marketed for professional use.

Glucose is a sugar that is the major energy source in the body. Maintaining appropriate glucose levels is very important. This system may be used to measure glucose levels. A MEMo Chip is provided with each package of test strips and must be properly inserted into the analyzer before any test can be run. The MEMo Chip contains test name, calibration curve, lot number, and test strip expiration date. After the test strip is inserted into the analyzer and blood applied to the test strip, test results are displayed in about 10 seconds if testing eGLU only, or about 2 minutes if, for example, run in conjunction with a PTS Panels Lipid Panel test strip.

The eGLU test strips use electrochemical (amperometric) technology to produce a glucose result. When the blood is applied to the test strip, the blood starts a chemical reaction that produces an electrical current. The current is converted into a glucose result and is displayed on the analyzer screen.

EXPECTED VALUES Blood glucose levels will vary from time to time depending on food consumed, activity levels, health status, medication dosages, stress or exercise. Your physician or healthcare professional will discuss “target values” (that is, highs and lows) specifically appropriate for you. A glucose level below 50 mg/dL (2.78 mmol/L) or above 240 mg/dL (13.32 mmol/L) may indicate a serious medical condition. If your test result should fall below 50 mg/dL (2.78 mmol/L) or exceed 240 mg/ dL (13.32 mmol/L), you should contact your physician or healthcare professional as soon as possible. Expected values for a fasting person, who does not have diabetes, are: 70-105 mg/dL (3.9-5.8 mmol/L).

1. Store test strip package in a cool, dry place at room temperature of 68-86°F (20-30°C). Test strips may be stored in a refrigerator at 35-46°F (2-8°C), but must be brought to room temperature before using. Do not freeze.
2. Keep away from heat and direct sunlight.
3. Do not remove or discard the desiccant packet in the vial.
4. Always replace vial cap immediately after removing a test strip.
5. Use test strip as soon as you have removed it from the vial.
6. Keep the MEMo Chip either in the analyzer or stored with the original lot of test strips.
7. Store the test strips in the original vial. Do not combine with other test strips and do not store the MEMo Chip in the test strip vial.
8. After opening, the test strips are stable until expiration date if vial is properly stored and always capped