i-SENS CareSens N Premier, Руководство пользователя

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Performance Characteristics
System Accuracy and Measurement Precision
The performance of CareSens N Premier Blood Glucose
Monitoring System has been evaluated in laboratory and in
clinical tests.
Accuracy: The accuracy of the CareSens N Premier Blood
Glucose Monitoring System (Model GM01AAB) 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 1.0041
Y-intercept -1.93 mg/dL (-0.1 mmol/L)
Correlation coefficient (r) 0.9933
Number of Subjects 600
Range tested 28.6–512 mg/dL
(1.6–28.4 mmol/L)
System accuracy results for glucose concentration < 100 mg/dL
(5.55 mmol/L)
Within ±5 mg/dL
(±0.28 mmol/L)
Within ±10 mg/dL
(±0.56 mmol/L)
Within ±15 mg/dL
(±0.83 mmol/L)
150/186 (80.6 %) 172/186 (92.5 %) 186/186 (100.0 %)
System accuracy results for glucose concentration ≥ 100 mg/dL
(5.55 mmol/L)
Within ±5 % Within ±10 % Within ±15 %
333/414 (80.4 %) 404/414 (97.6 %) 414/414 (100.0 %)