Performance Characteristics - i-SENS GM505PAD User 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
GM505PAD, GM505PBD, GM505PCD) 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) 0.994
Number of samples
Range tested
Accuracy results for glucose concentration < 5.55 mmol/L
Within ± 0.28 mmol/L Within ± 0.56 mmol/L
100/186 (53.8%)
169/186 (90.9%)
Accuracy results for glucose concentration ≥ 5.55 mmol/L
Within ± 5% Within ± 10%
266/414 (64.3%) 395/414 (95.4%)
System accuracy results for glucose concentrations between
1.6 mmol/L and 27.1 mmol/L
Within ± 0.83 mmol/L and Within ± 15%
589/600 (98.2%)
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0.946
0.37 mmol/L
600
1.6-27.1 mmol/L
Within ± 0.83 mmol/L
180/186 (96.8%)
Within ± 15%
409/414 (98.8%)
Precision: The precision studies were performed in a laboratory
using CareSens N BGM Systems.
Within Run Precision
Blood avg. 2.1 mmol/L
Blood avg. 3.2 mmol/L
Blood avg. 6.7 mmol/L
Blood avg. 9.7 mmol/L
Blood avg. 16.8 mmol/L
Total Precision
Control avg. 2.2 mmol/L
Control avg. 6.7 mmol/L
Control avg. 17.7 mmol/L
This study shows that there could be variation of up to 3.6%.
Packed Cell Volume (Hematocrit)
The hematocrit levels (15–65%) were tested to evaluate the effect
of hematocrit level on measurement of glucose concentration.
Range (mmol/L)
1.7 to 2.8
5.3 to 8.0
15.5 to 23.3
SD = 0.1 mmol/L
SD = 0.1 mmol/L
CV = 3.6%
CV = 2.8%
CV = 3.2%
SD = 0.1 mmol/L
CV = 3.5%
CV = 2.6%
Average difference (Hct 15–65%)
-0.2–0.1 mmol/L
-1.5–7.1%
-5.4–1.1%
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