Performance Characteristics - 2in1 BASIC Gebrauchsanweisung

PERFORMANCE CHARACTERISTICS

Clinical accuracy
The accuracy of the
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)
within ±5 mg/dL (0.28 mmol/L)
within ±10 mg/dL (0.56 mmol/L)
within ±15 mg/dL (0.83 mmol/L)
System accuracy result for lucose concentrations
≥ 100 mg/dL(5.5 mmol/L)
within ±5%
within ±10%
within ±15%
within ±20%
Regression statistics
Slope
Intercept
R 2
No. of samples
Range tested
2in1.® BASIC System was assessed by
2in1.® BASIC System
95%
100%
100%
2in1.® BASIC System
94%
100%
100%
100%
2in1.® BASIC System
1.0184
-0.9642 mg/dL
0.9981
100
31.5~448 mg/dL
37