Performance Characteristics
46
This study shows that the system compares well with a laboratory method
and meets the minimum acceptable performance criteria defined in
IEC 60601-1-2.
The performance of the system has been evaluated both in laboratory and
in clinical tests.
Range: The display range of the meter is 0.5mmol/L to 33.3 mmol/L
(9mg/dL to 600 mg/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
Glucose Analyzer, a laboratory
instrument.
Table1. System accuracy results for glucose concentration <5.55 mmol/L
Y
SI
Table2. System accuracy results for glucose concentration
≥
5.55mmol/L
generally should fall within 0.83mmol/L (15 mg/dL) of the laboratory
result.
If the blood glucose is below 5.5mmol/L(100mg/dL), the results
the results generally should fall within ±15 % of the laboratory result.
If the blood glucose is equal to or over 5.55mmol/L
（
100mg/dL),
Within ±0,28 mmol/L
Within ±0,56 mmol/L Within± 0,83 mmol/L
Bias
Percentage
(within±5mg/dl)
(within±10mg/dl)
(within±15mg/dl)
Percentage
Within ±5 %
Within ±10 %
Within ±15 %
Bias
67.4% (287/426) 99.8% (4254/426) 100.0% (426/426)
132/174 (75.9%) 173/174 (99.4%) 174/174 (100.0%)
