Performance Characteristics - i-SENS CareSens N Manual

Performance Characteristics
The performance of CareSens N Blood Glucose Monitoring
System has been evaluated in laboratory and in clinical tests.
Accuracy: The accuracy of the CareSens N BGM System (Model
GM505NA, GM505NB, GM505NC) 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 sample
Range tested
Accuracy results for glucose concentration < 4.2 mmol/L
(Within ± 0.28 mmol/L ) (Within ± 0.56 mmol/L ) (Within ± 0.83 mmol/L )
13/17 (76%) 16/17 (94%)
Accuracy results for glucose concentration ≧ 4.2mmol/L
Within ± 5% Within ± 10%
45/93 (48%) 88/93 (96%)
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0.961
0.194 mmol/L
0.995
110
1.7~26.9 mmol/L
17/17 (100%)
Within ± 15% Within ± 20%
93/93 (100%) 93/93 (100%)
Precision: The precision studies were performed in a laboratory
using CareSens N BGM Systems.
Within Run Precision
Blood average 2.1 mmol/L
Blood average 4.8 mmol/L
Blood average 6.9 mmol/L
Blood average 10.5 mmol/L
Blood average 18.6 mmol/L
Total Precision
Control average 2.4 mmol/L
Control average 6.3 mmol/L
Control average 21.2 mmol/L
This study shows that there could be variation of up to 4.2%
SD = 0.1 mmol/L
SD = 0.2 mmol/L
CV = 4.1%
CV = 2.6%
CV = 2.8%
SD = 0.1 mmol/L
CV = 3.3%
CV = 4.2%
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