Introduction
The Accu-Chek Instant blood glucose meter is intended for in vitro diagnostic use by people with diabetes and healthcare professionals in clinical settings.
Intended Use
The meter is designed to quantitatively measure glucose in fresh capillary whole blood from the finger, palm, forearm, and upper arm as an aid in monitoring the effectiveness of glucose control.
Performance Characteristics
The system has been tested at altitudes up to 3,094 meters and complies with the requirements of ISO 15197:2013 for blood glucose monitoring systems for self-testing in managing diabetes mellitus.
The system has been calibrated with venous blood containing various glucose concentrations as calibrator, and the reference values are obtained using the hexokinase method.
System Accuracy
The system accuracy results for glucose concentrations less than 100 mg/dL are within ±5 mg/dL, and for concentrations equal to or greater than 100 mg/dL, the results are within ±10%.
Repeatability
The repeatability of the system is within ±15 mg/dL or ±15% for glucose concentrations between 39 mg/dL and 482 mg/dL.
Test Principle
The enzyme on the test strip, a FAD-dependent glucose dehydrogenase (GDH), converts the glucose in the blood sample to gluconolactone, creating a harmless DC electrical current that the meter interprets for the blood glucose result.
Manual:
Download: Accu-Chek Instant Blood Glucose Meter User Manual
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