Gmate WHeeL System - Performance Characteristics

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P erformance Char acteristics
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™ WHeeL System was
assessed by comparing blood glucose results obtained by
patients with those obtained using a YSI 2300 Glucose Analyzer.
Clinical accuracy
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)
27% (8/30)
93% (28/30)
100% (30/30)
within ±5%
within ±10%
within ±15%
within ±20%
58% (99/170)
95% (162/170)
99% (169/170)
100% (170/170)
Slope
Intercept
R²
No. of samples
Range tested
1.0004
-2.1214 mg/dL
0.9903
100
32.7~442 mg/dL(1.8~24.5 mmol/L)
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Within run precision(100 venous blood tests per glucose level)
Total precision(100 control solution tests per glucose level)
Perf ormance Characteristics
Standard
deviation
1.3 mg/dL(0.07 mmol/L)
2.6 mg/dL(0.14 mmol/L)
2.6 mg/dL(0.14 mmol/L)
3.6 mg/dL(0.20 mmol/L)
8.8 mg/dL(0.49 mmol/L)
Mean glucose
43 mg/dL(2.3 mmol/L)
101 mg/dL(5.6 mmol/L)
133 mg/dL(7.3 mmol/L)
232 mg/dL(12.8 mmol/L)
373 mg/dL(20.7 mmol/L)
Coefficient of
variation(%)
3.1
2.5
2.0
1.6
2.4
Standard
deviation
0.8 mg/dL(0.04 mmol/L)
2.5 mg/dL(0.14 mmol/L)
8.5 mg/dL(0.47 mmol/L)
Mean glucose
41 mg/dL(2.2 mmol/L)
103 mg/dL(5.7 mmol/L)
295 mg/dL(16.3 mmol/L)
Coefficient of
variation(%)
2.0
2.4
2.9