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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)
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)
Repeatability (using venous whole blood):
Level
41.8 mg/dL
101 mg/dL
145 mg/dL
198 mg/dL
326 mg/dL
% of result
69
96
100
SD
CV
2.6 mg/dL
7.6%
2.5 mg/dL
2.5%
3.2 mg/dL
2.3%
5.4 mg/dL
2.9%
8.0 mg/dL
2.4%
For glucose concentration ≥ 75 mg/dL (4.2 mmol/L)
Accuracy Range
Within ±5%
Within ±10%
Within ±15%
Within ±20%
Repeatability (using control):
Level
32.1 mg/dL
123 mg/dL
280 mg/dL
% of result
66
98
100
100
SD
CV
2.1 mg/dL
5.9%
3.3 mg/dL
2.6%
5.7 mg/dL
1.7%
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