I-SENS CareSens II Owner's Booklet - page 23
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CareSens II BGM System (Model GM505C)
Precision:
Precision studies were performed in a laboratory using the
CareSens II BGM System.
Within Run Precision
Blood average
42 mg/dL (2.3 mmol/L)
Blood average
98 mg/dL (5.4 mmol/L)
Blood average
142 mg/dL (7.9 mmol/L)
Blood average
209 mg/dL (11.6 mmol/L)
Blood average
339 mg/dL (18.8 mmol/L)
Total Precision
Blood average
44 mg/dL (2.4 mmol/L)
Blood average
137 mg/dL (7.6 mmol/L)
Blood average
355 mg/dL (19.7 mmol/L)
SD=1.7 mg/dL
(0.1 mmol/L)
3.7%
4.0%
This study shows that there could be variation of up to 4.0%
Within ± 5 mg/dL
(Within± 0.28 mmol/L)
13/19 (68%)
Within ± 10 mg/dL
(Within± 0.56 mmol/L)
18/19 (95%)
Within ± 15 mg/dL
(Within± 0.83 mmol/L)
19/19 (100%)
Within ± 5%
66/96 (69%)
Within ±10%
92/96 (96%)
Within ± 15%
96/96 (100%)
Within ± 20%
96/96 (100%)
Performance Characteristics
The performance of CareSens II Blood Glucose Monitoring System
Strips has been evaluated in laboratory and in clinical tests.
Accuracy:
CareSens II BGM Systems are calibrated to yield results
equivalent to plasma glucose concentrations. The accuracy of the
CareSens II System was evaluated 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 115 diabetic patients at
clinic centers.
Slope
0.961
Y-intercept
3.5 mg/dL
Correlation coefficient (r)
0.995
Number of samples
115
Range tested
40-521 mg/dL
Accuracy results for glucose concentration < 75 mg/dL (4.2 mmol/L)
CareSens II (Model GM505C)
Accuracy results for glucose concentration ≧75 mg/dL (4.2 mmol/L)
CareSens II (Model GM505C)
SD=1.7 mg/dL
(0.1 mmol/L)
SD=2.9 mg/dL
(0.2 mmol/L)
CV=2.9%
CV=3.3%
CV=3.6%