Performance Characteristics
- The performance of the GlucoDr auto Test Strips has been evaluated in clinical tests.
Accuracy:
The accuracy of the GlucoDr auto Blood Glucose Monitoring System was assessed by
comparing blood glucose test results obtained from 140 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
42.7 mg/dL
109.5 mg/dL
149 mg/dL
202 mg/dL
345 mg/dL
2.3 mg/dL
2.5 mg/dL
3.3 mg/dL
3.7 mg/dL
4.4 mg/dL
SD
5.3%
2.3%
2.2%
1.8%
1.3%
CV
36.5 mg/dL
125 mg/dL
325 mg/dL
Level
1.9 mg/dL
3.1 mg/dL
8.2 mg/dL
SD
5.3%
2.4%
2.5%
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
71
100
100
Accuracy Range
Within ±5%
Within ±10%
Within ±15%
Within ±20%
% of result
59
89
100
100
For glucose concentration
≥
75 mg/dL(4.2 mmol/L)