Performance Characteristics
42
The performance of the system has been evaluated both in laboratory and
in clinical tests.
•
Range: The display range of the meter is 2.2mmol/L to 33.3mmol/L
(40mg/dL to 600mg/dL). "HI" and "Lo" messages indicate results
outside of this range.
•
Accuracy: The accuracy of the system was assessed by comparing
blood glucose results obtained using EKF Glucose Analyzer, a laboratory
instrument.
Table1. System accuracy results for glucose concentration < 5.55 mmol/L
(100 mg/dL)
Table2. System accuracy results for glucose concentration
≥
5.55mmol/L
(100 mg/dL)
measured glucose results should fall within ±0.83mmol/L (±15 mg/dL) of
the laboratory result.
When the blood glucose is below 5.55mmol/L (100 mg/dL), 100% of
100% of measured glucose results should fall within ±15 % of the laboratory
result.
When the blood glucose is equal to or above 5.55mmol/L (100 mg/dL),
Within ±0.83mmol/L
(Within ±15mg/dL)
Within ±0.56mmol/L
(Within ±10mg/dL)
Within ±0.28mmol/L
(Within ±5mg/dL)
Within ±5%
Within ±10%
Within ±15%
107/156(68.6%)
156/156(100.0%) 156/156(100.0%)
426/444(95.9%) 444/444(100.0%) 444/444(100.0%)
