Performance Characteristics - ReliOn Premier BLU Manual Del Usuario

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
Y-Intercept
Correlation coefficient (r)
Number of subjects
Range tested
Accuracy results for glucose concentration < 75 mg/dL
Within ± 5 mg/dL Within ± 10 mg/dL Within ± 15 mg/dL
61.0% (25/41)
Accuracy results for glucose concentration ≥ 75 mg/dL
Within ± 5%
61.0% (25/41)
97.6% (40/41)
Within ± 10% Within ± 15% Within ± 20%
96.1% (317/330) 100% (330/330) 100% (330/330)
1.0223
-1.3686
0.9934
371
48 mg/dL – 553 mg/dL
100% (41/41)
59