System Specifications - philosys Gmate On User Manual

PM110-CE0-2105_Gmate On_user guide_20170621.indd 40

System Specifications

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™ On 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
< 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 glucose concentrations
≥ 100 mg/dL(5.5 mmol/L)
within ±5 %
within ±10 %
within ±15 %
Regression statistics
Slope
Intercept
R²
No. of samples
Range tested
40
87.3% (165/189)
100% (189/189)
100% (189/189)
90.9% (374/411)
100% (411/411)
100% (411/411)
0.9857
2.9141 mg/dL
0.9976
600
34.2-447 mg/dL (1.9 - 24.8 mmol/L)
2017-08-03 �� 9:41:32