34
Performance Characteristics
Clinical accuracy
The accuracy of the Gmate™ 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 < 75 mg/dL(4.2 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)
Gmate
TM
mini System
87%(26/30)
100%(30/30)
100%(30/30)
System accuracy result for glucose concentrations ≥ 75 mg/dL(4.2 mmol/L)
within ±5%
within ±10%
within ±15%
Gmate
TM
mini System
72%(120/170)
94%(160/170)
99%(169/170)
within ±20%
100%(170/170)
Regression statistics
Slope
Intercept
R
2
Gmate
TM
mini System
0.9995
-1.9724 mg/dL
0.9961
No. of samples 100
Range tested 31.4~430 mg/dL
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