Blood Glucose Monitor
Performance Characteristics Precision
Tests were carried by trained technicians in the laboratory setting. The venous whole blood from one subject was adjusted to 6 different levels. Strips out of a single lot were tested.
600 samples at glucose concentration 46~576 mg/dL were tested at the hospital by healthcare professionals. Fresh capillary finger whole blood samples were tested with FIA BiomedTM System; plasma samples from the subjects were tested with YSI Model 2300 Glucose Analyzer as reference.
100 samples at glucose concentration 76~339 mg/dL were tested at hospital by lay user. 94.7% within ±0,83 mmol/L (±15 mg/dL) of the medical laboratory values at glucose concentrations below 5,55 mmol/L (100 mg/dL), and 100% within ±15% of the medical laboratory values at glucose concentrations at or above 5,55 mmol/L (100 mg/dL).