User's Manual

www.i-sens.com
46
www.i-sens.com
45
Performance Characteristics
The performance of CareSens N Blood Glucose Monitoring System
Strips has been evaluated in laboratory and in clinical tests.
Accuracy: The accuracy of the CareSens N BGM System (Model
GM505LE) 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 110 diabetic patients at clinic
centers.
Slope 0.961
Y-intercept 3.5 mg/dL
Correlation coefficient (r) 0.995
Number of sample 110
Range tested 30~485 mg/dL
Accuracy results for glucose concentration<75 mg/dL (4.2mmol/L)
Within ± 5 mg/dL
(Within ± 0.28 mmol/L )
Within ±10 mg/dL
(Within ± 0.56 mmol/L )
Within ±15 mg/dL
(Within ± 0.83 mmol/L )
13/17 (76%) 16/17 (94%) 17/17 (100%)
Accuracy results for glucose concentration≧75 mg/dL (4.2mmol/L)
Within ± 5% Within ± 10% Within ± 15% Within ± 20%
45/93 (48%) 88/93 (96%) 93/93 (100%) 93/93 (100%)
Precision: Precision studies were performed in a laboratory
using the CareSens LINK BGM System.
Within Run Precision
Blood average
SD = 1.9 mg/dL (0.11 mmol/L)
Blood average
CV = 3.7%
Blood average
CV = 4.1%
Blood average
CV = 2.6%
Blood average
CV = 2.8%
This study shows that there could be variation of up to 4.2%
Total Precision
Control average
SD = 2.0 mg/dL (0.11 mmol/L)
Control average
CV = 3.3%
Control average
38.1 mg/dL (2.1 mmol/L)
86.1 mg/dL (4.8 mmol/L)
124.5 mg/dL (6.9 mmol/L)
189.1 mg/dL (10.5 mmol/L)
334.5 mg/dL (18.6 mmol/L)
43.1 mg/dL (2.4 mmol/L)
113.4 mg/dL (6.3 mmol/L)
381.2 mg/dL (21.2 mmol/L)
CV = 4.2%