Performance Characteristics; System Accuracy And Measurement Precision - i-SENS CareSens Dual User Manual

Performance Characteristics

System Accuracy and Measurement Precision

The performance of CareSens Dual Blood Glucose/Blood
β-Ketone Monitoring System has been evaluated in laboratory
and in clinical tests.
Glucose
Accuracy: The accuracy of the CareSens Dual Blood Glucose
Monitoring System (Model: GM01HAC) 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 tests
Range tested
System accuracy results for glucose concentration < 100 mg/dL
(5.55 mmol/L)
Within ±5 mg/dL
(Within ±0.28 mmol/L)
136/204 (66.7 %)
System accuracy results for glucose concentration ≥ 100 mg/dL
(5.55 mmol/L)
Within ±5 %
264/396 (66.7 %)
0.964
3.579 mg/dL (0.199 mmol/L)
0.997
600
46.2–526 mg/dL (2.6–29.2 mmol/L)
Within ±10 mg/dL
(Within ±0.56 mmol/L)
197/204 (96.6 %)
Within ±10 %
379/396 (95.7 %)
Within ±15 mg/dL
(Within ±0.83 mmol/L)
203/204 (99.5 %)
Within ±15 %
395/396 (99.7 %)
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