Arkray Glucocard Shine - Performance Characteristics

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Performance Characteristics
The performance of GLUCOCARD Shine Blood Glucose
Monitoring System has been evaluated in laboratory and clinical
tests.
ACCURACY: The GLUCOCARD Shine BGM System is calibrated
to yield results equivalent to plasma glucose concentrations.
The accuracy of the GLUCOCARD Shine System was tested
by comparing blood glucose results obtained by patients with
those obtained using a YSI Model 2300 Glucose Analyzer, a lab
instrument. The results below were obtained by diabetic patients
at clinic centers.
Within ± 5% Within ± 10% Within ± 15% Within ± 20%
79/95 (83.2%) 94/95 (98.9%) 95/95 (100%) 95/95 (100%)
5/5 (100%)
Accuracy results for glucose concentration < 75 mg/dL
Accuracy results for glucose concentration ≥ 75 mg/dL
5/5 (100%) 5/5 (100%)
Within ± 10 mg/dLWithin ± 5 mg/dL Within ± 15 mg/dL
Slope 1.023 1.006
Y-intercept -2.07 mg/dL -0.41 mg/dL
Correlation coefficient(r) 0.996 0.994
Number of sample 100 100
Range tested 66-321 mg/dL 66-321 mg/dL
Obtainedbyhealthcare
professionals
Obtainedby
layusers