Arkray GLUCOCARD Shine Connex Manual Del Usuario página 59

Performance Characteristics
The performance of GLUCOCARD Shine Connex Blood Glucose
Monitoring System has been evaluated in laboratory and in
clinical tests.
Accuracy
The accuracy of the GLUCOCARD Shine Connex Blood Glucose
Monitoring System 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
Elation coefficient (r)
Number of subjects
Range tested
Accuracy results for glucose concentration < 75 mg/dL
Within ± 5 mg/dL
61.0 %
(25/41)
Accuracy results for glucose concentration ≥ 75 mg/dL
Within ± 5 % Within ± 10 % Within ± 15 % Within ± 20 %
70.0 %
(231/330)
1.0223
-1.3686
0.9934
371
48–553 mg/dL
Within ± 10 mg/dL Within ± 15 mg/dL
97.6 %
(40/41)
96.1 %
(317/330)
100 %
(330/330)
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100 %
(41/41)
100 %
(330/330)