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 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
(
100 mg/dL)
YSI
Table2. System accuracy results for glucose concentration
≥
5.55mmol/L
thin ±0.83mmol/L (±15 mg/dL)
of the laboratory result.
When the blood glucose is below 5.55mmol/L(100mg/dL), 100% of
measured glucose results should fall wi
When
measured glucose results should fall within ±15 % of the laboratory result.
the blood glucose is equal to or above 5.55mmol/L 00mg/dL), 99.1% of
(1
(
100 mg/dL)
Within
(Within ±15mg/dL)
±0.83mmol/L
Within
(Within ±10mg/dL)
±0.56mmol/L
Within
(Within ±5mg/dL)
±0.28mmol/L
118/150
)
(78.7%
150/150
)
(100%
150/150
)
(100%
Within ±5%
Within ±10%
Within ±15%
Within ±20%
277/450(61.6%)
400/450(88.9%)
446/450(99.1%)
450/450(100%)
