Performance Characteristics; System Accuracy And Measurement Precision - i-SENS CareSens N POP Owner's Booklet

Performance Characteristics

System Accuracy and Measurement Precision

The performance of CareSens N POP Blood Glucose Monitoring
System has been evaluated in laboratory and in clinical tests.
Accuracy: The accuracy of the CareSens N POP Blood Glucose
Monitoring System (Model GM505WAC, GM505WBC) was
assessed by comparing blood glucose results obtained by
patients with those obtained using a YSI Model 2300 Glucose
Analyzer, a laboratory instrument. The following results were
obtained by diabetic patients at clinic centers.
Slope
Y-intercept
Correlation coefficient (r)
Number of Samples
Range tested
System accuracy results for glucose concentration < 5.55 mmol/L
Within ±0.28 mmol/L
74/156 (47.4 %)
System accuracy results for glucose concentration ≥ 5.55 mmol/L
Within ±5 %
288/444 (64.9 %)
System accuracy results for glucose concentrations between
2.0 mmol/L and 26.4 mmol/L
Within ±0.83 mmol/L and Within ± 5 %
48 www.i-sens.com
1.0009
0.10 mmol/L
0.995
600
2.0 mmol/L–26.4 mmol/L
Within ±0.56 mmol/L
133/156 (85.3 %)
Within ±10 %
413/444 (93.0 %)
598/600 (99.7 %)
Within ±0.83 mmol/L
155/156 (99.4 %)
Within ±15 %
443/444 (99.8 %)