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