Safety Information

Performance Characteristics
44
This study shows that the system compares well with a laboratory method
and meets the minimum acceptable performance criteria defined in
ISO 15197.
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 <5.5 mmol/L
YSI
Table2. System accuracy results for glucose concentration ≥5.5mmol/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 5.5mmol/L（100mg/dL),
Within ±0,28 mmol/L
118/150(78.7%)
Within ±0,56 mmol/L
150/150(100%) 150/150(100%)
Within± 0,83 mmol/L
Bias
Percentage
(within±5mg/dl)
(within±10mg/dl)
(within±15mg/dl)
Percentage
Within ±5 %
277/450(61.6%)
Within ±10 %
400/450(88.9%)
Within ±15 %
446/450(99.1%)
Bias