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Within Run Precision
Blood avg. 41 mg/dL (2.3 mmol/L)
SD = 2.2 mg/dL (0.1 mmol/L)
Blood avg. 73 mg/dL (4.1 mmol/L)
SD = 2.3 mg/dL (0.1 mmol/L)
Blood avg. 124 mg/dL (6.9 mmol/L)
CV = 3.2%
Blood avg. 182 mg/dL (10.1 mmol/L) CV = 3.0%
Blood avg. 316 mg/dL (17.6 mmol/L) CV = 2.2%
Precision: The precision studies were performed in a laboratory
using CareSens PRO Blood Glucose Monitoring Systems.
Total Precision
Control avg. 35 mg/dL (1.8 mmol/L)
SD = 1.9 mg/dL (0.1 mmol/L)
Control avg. 112 mg/dL (6.9 mmol/L)
CV = 3.4%
Control avg. 319 mg/dL (19.4 mmol/L) CV = 3.7%
This study shows that there could be variation of up to 3.7%
Within ± 15 mg/dL (Within ± 0.83 mmol/L) and Within ± 15%
592/600 (98.7%)
System accuracy results for glucose concentrations between
32.4 mg/dL (1.8 mmol/L) and 606 mg/dL (33.7 mmol/L)
Packed Cell Volume (Hematocrit)
The hematocrit levels (15–65%) were tested to evaluate the effect of
hematocrit level on measurement of glucose concentration.
30 to 50 (1.7 to 2.8)
-3.3–1.7 mg/dL (-0.2–0.1 mmol/L)
96 to 144 (5.3 to 8.0)
-3.6 –1.7%
280 to 420 (15.5 to 23.3)
-8.9–6.2%
Range (mg/dL (mmol/L))
Average of difference (Hct 15–65%)
Performance Characteristics
The performance of CareSens PRO Blood Glucose Monitoring
System has been evaluated in laboratory and in clinical tests.
Accuracy: The accuracy of the CareSens PRO Blood Glucose
Monitoring System (Model: GM01HAA) 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
0.9871
y-intercept
9.504 mg/dL (0.528 mmol/L)
Correlation coefficient (r) 0.9926
Number of sample
600
Range tested
32.4–606 mg/dL (1.8–33.7 mmol/L)
Within ± 5%
Within ± 10%
Within ± 15%
180/450 (40.0%)
352/450 (78.2%)
442/450 (98.2%)
89/150 (59.3%)
System accuracy results for glucose concentration < 100 mg/dL
(5.55 mmol/L)
System accuracy results for glucose concentration ≥ 100 mg/dL
(5.55 mmol/L)
140/150 (93.3%)
150/150 (100%)
Within ± 10 mg/dL
(Within ± 0.56 mmol/L)
Within ± 5 mg/dL
(Within ± 0.28 mmol/L)
Within ± 15 mg/dL
(Within ± 0.83 mmol/L)
