Performance Characteristics
- The performance of the GlucoDr SuperSensor Test Strips has been evaluated in clinical tests.
Accuracy:
- The accuracy of the GlucoDr SuperSensor Blood Glucose Monitoring System was assessed
by comparing blood glucose test results obtained from 100 diabetic patients with those
obtained using YSI Model 2300 STAT Plus Glucose Analyzer.
For glucose concentration < 75 mg/dL (4.2 mmol/L)
Repeatability (using venous whole blood):
Level
42.1 mg/dL
105 mg/dL
142 mg/dL
200 mg/dL
345 mg/dL
2.6 mg/dL
3.2 mg/dL
4.1 mg/dL
4.9 mg/dL
7.6 mg/dL
SD
6.3%
3.0%
2.9%
2.5%
2.2%
CV
38.1 mg/dL
137 mg/dL
359 mg/dL
Level
1.3 mg/dL
2.8 mg/dL
7.0 mg/dL
SD
3.5%
2.1%
2.0%
CV
Repeatability (using control):
Accuracy Range
Within ±5 mg/dL (0.28 mmol/L)
Within ±10 mg/dL (0.56 mmol/L)
Within ±15 mg/dL (0.83 mmol/L)
% of result
56
89
100
Accuracy Range
Within ±5%
Within ±10%
Within ±15%
Within ±20%
% of result
78
97
100
100
For glucose concentration
≥
75 mg/dL (4.2 mmol/L)
