Performance Characteristics - i-SENS CARESENS DUAL Owner's Booklet

Performance Characteristics

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 < 5.55 mmol/L
Within ± 0.28 mmol/L Within ± 0.56 mmol/L
136/204 (66.7%) 197/204 (96.6%)
System accuracy results for glucose concentration ≥ 5.55 mmol/L
Within ± 5% Within ± 10%
264/396 (66.7%) 379/396 (95.7%)
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0.964
0.199 mmol/L
0.997
600
2.6–29.2 mmol/L
Within ± 0.83 mmol/L
203/204 (99.5%)
Within ± 15%
395/396 (99.7%)
System accuracy results for glucose concentrations between
2.6 mmol/L and 29.2 mmol/L
Within ± 0.83 mmol/L and Within ± 15%
598/600 (99.7%)
Precision: The precision studies were performed in a laboratory
using CareSens Dual Blood Glucose Monitoring Systems.
Within Run Precision
Blood avg. 2.5 mmol/L
Blood avg. 4.3 mmol/L
Blood avg. 6.9 mmol/L
Blood avg. 10.3 mmol/L
Blood avg. 16.3 mmol/L
Between Run Precision
Control avg. 2.3 mmol/L
Control avg. 6.7 mmol/L
Control avg. 17.3 mmol/L
This study shows that there could be variation of up to 4.2%
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
215.5 to 23.3
0.1 mmol/L
0.2 mmol/L
CV = 4.2%
CV = 3.3%
CV = 3.0%
0.1 mmol/L
CV = 4.1%
CV = 3.1%
Average of difference (Hct 15–65%)
-0.2–0.1 mmol/L
-3.6–1.7 %
-8.9–6.2 %
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