Performance Characteristics
- The performance of the GlucoDr Plus Test Strips has been evaluated in clinical tests.
Accuracy:
- The accuracy of the GlucoDr Plus 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
41.8 mg/dL
101 mg/dL
145 mg/dL
198 mg/dL
326 mg/dL
2.6 mg/dL
2.5 mg/dL
3.2 mg/dL
5.4 mg/dL
8.0 mg/dL
SD
7.6%
2.5%
2.3%
2.9%
2.4%
CV
32.1 mg/dL
123 mg/dL
280 mg/dL
Level
2.1 mg/dL
3.3 mg/dL
5.7 mg/dL
SD
5.9%
2.6%
1.7%
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
69
96
100
Accuracy Range
Within ±5%
Within ±10%
Within ±15%
Within ±20%
% of result
66
98
100
100
For glucose concentration
≥
75 mg/dL (4.2 mmol/L)
