33
Clinical accuracy
The 2in1. SMART is calibrated to yield results equivalent to plas-
ma glucose concentrations and is traceable to a NIST standard.
The accuracy of the 2in1. SMART System was assessed by com-
paring 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)
System accuracy result for glucose
concentrations
≥
100 mg/dL (5.5 mmol/L)
within ±5 mg/dL
(0.28 mmol/L)
97%
within ±10 mg/dL
(0.56 mmol/L)
100%
within ±15 mg/dL
(0.83 mmol/L)
100%
within ±5%
92%
within ±10%
100%
within ±15%
100%
Performance Characteristics
