Performance Characteristics - i-SENS CareSens N Owner's Booklet

Performance Characteristics

The performance of CareSens N NFC Blood Glucose Monitoring
System has been evaluated in laboratory and in clinical tests.
Accuracy: The accuracy of the CareSens N NFC BGM System
(Model GM505PAG, GM505PBG, GM505PCG) 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 < 100 mg/dL (5.55 mmol/L)
Within ± 5 mg/dL Within ± 10 mg/dL
(Within ± 0.28 mmol/L) (Within ± 0.56 mmol/L)
112/180 (62.2%) 172/180 (95.6%)
Accuracy results for glucose concentration ≥ 100 mg/dL (5.55 mmol/L)
Within ± 5% Within ± 10%
304/420(72.4%) 413/420(98.3%)
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0.9859
1.8724 mg/dL (0.10 mmol/L)
0.996
600
27.9–479 mg/dL
(1.6–26.6 mmol/L)
Within ± 15 mg/dL
(Within ± 0.83 mmol/L)
180/180 (100%)
Within ± 15%
420/420(100%)
System accuracy results for glucose concentrations between 27.9
mg/dL (1.6 mmol/L) and 479 mg/dL(26.6 mmol/L)
Within ± 15 mg/dL (Within ± 0.83 mmol/L) and Within ± 15%
600/600 (100%)
Precision: The precision studies were performed in a laboratory
using CareSens N NFC BGM Systems.
Within Run Precision
*Bloodav avg. 35 mg/dL (1.9 mmol/L)
*Bloodav avg. 65 mg/dL (3.6 mmol/L)
*Bloodav avg. 129 mg/dL (7.2 mmol/L)
*Bloodav avg. 175 mg/dL (9.7 mmol/L)
*Bloodav avg. 330 mg/dL (18.3 mmol/L) CV = 2.1%
Between Run Precision
*Controlav avg. 38 mg/dL (2.1 mmol/L)
*Controlav avg. 120 mg/dL (6.7 mmol/L)
*Controlav avg. 318 mg/dL (17.7 mmol/L) CV = 2.4%
This study shows that there could be variation of up to 3.2%.
Packed Cell Volume (Hematocrit)
The hematocrit levels (15–65%) were tested to evaluate
the effect of hematocrit level on measurement of glucose
concentration.
Range
30 to 50 mg/dL (1.7 to 2.8 mmol/L)
96 to 144 mg/dL (5.3 to 8.0 mmol/L)
280 to 420 mg/dL (15.5 to 23.3 mmol/L)
SD = 1.7 mg/dL (0.1 mmo/L)
SD = 2.0 mg/dL (0.1 mmo/L)
CV = 3.0%
CV = 3.0%
SD = 1.4 mg/dL (0.1 mmol/L)
CV = 3.2%
Average of difference (Hct 15–65%)
-3.1 – 1.9 mg/dL (-0.2 – 0.1 mmol/L)
-1.5 – 7.1%
-5.4 – 1.1%
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