37
Performance Characteristics
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)
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%
63%(107/170)
within
±
20%
Regression statistics
Slope
Intercept
R
2
0.9955
-1.9843 mg/dL
0.9954
No. of samples
100
Range tested
31.4~430 mg/dL(1.7~23.9 mmol/L)
95%(162/170)
99%(169/170)
100%(170/170)
Clinical accuracy
The Gmate™ System is calibrated to yield results equivalent to
plasma glucose concentrations and is traceable to a NIST standard.
The accuracy of the Gmate™mini System was assessed by
comparing blood glucose results obtained by patients with those
obtained using a YSI 2300 Glucose Analyzer.
