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PERFORMANCE CHARACTERISTICS
Clinical accuracy
The accuracy of the
2in1.® BASIC
System was assessed by
comparing blood glucose results obtained by patients with
those obtained using a YSI 2300 Glucose Analyzer.
System accuracy result for glucose concentrations
< 100 mg/dL (5.5 mmol/L)
System accuracy result for lucose concentrations
≥
100 mg/dL(5.5 mmol/L)
Regression statistics
2in1.® BASIC
System
within ±5%
94%
within ±10%
100%
within ±15%
100%
within ±20%
100%
2in1.® BASIC
System
Slope
1.0184
Intercept
-0.9642 mg/dL
R
2
0.9981
No. of samples
100
Range tested
31.5~448 mg/dL
2in1.® BASIC
System
within ±5 mg/dL (0.28 mmol/L)
95%
within ±10 mg/dL (0.56 mmol/L)
100%
within ±15 mg/dL (0.83 mmol/L)
100%
