Gmate VOICE - Performance Characteristics; Clinical Accuracy Data; System Accuracy Results (< 75 mg;dL); System Accuracy Results (≥ 75 mg;dL)

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GMATE® VOICE PERFORMANCE CHARACTERISTICS
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Clinical accuracy
The accuracy of the Gmate® VOICE System was assessed by comparing the blood glucose test
results obtained from patients with those obtained using an YSI 2300 Glucose Analyzer.
System accuracy result for glucose concentrations < 75 mg/dL ( 4.2 mmol/L )
System accuracy result for glucose concentrations ≥ 75 mg/dL (4.2 mmol/L)
Regression statistics
within ± 5 mg/dL ( 0.28 mmol/L )
within ± 10 mg/dL ( 0.56 mmol/L )
within ± 15 mg/dL ( 0.83 mmol/L )
within ± 5%
within ± 10%
within ± 15%
within ± 20%
R
Slope
Intercept
2
No. of samples
Range tested
27% ( 4/15 )
93.3% ( 14/15 )
100% ( 15/15 )
59% ( 50/85 )
95% ( 81/85 )
100% ( 85/85 )
100% ( 85/85 )
0.9978
-2.1025 mg/dL
0.9905
100
32.7~442 mg/dL