Performance Characteristics - ReliOn Premier Classic Manual Del Usuario

Performance Characteristics

The performance of ReliOn™ Premier Classic Blood Glucose
Monitoring System has been evaluated in laboratory and
clinical tests.
Accuracy: The ReliOn™ Premier Classic Blood Glucose
Monitoring System is calibrated to yield results equivalent to
plasma glucose concentrations. The accuracy of the ReliOn™
Premier Classic 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.
Slope
Y-intercept
Correlation coefficient(r) 0.995
Number of samples
Range tested
• Accuracy results for glucose concentration < 75 mg/dL
Within ± 5 mg/dL
14/17 (82 %)
• Accuracy results for glucose concentration ≥ 75 mg/dL
Within ± 5 %
54/93 (58 %)
Obtained by healthcare
professionals
1.023
-1.86 mg/dL
110
30–485 mg/dL
Within ± 10 mg/dL
17/17 (100 %)
Within ± 10 %
82/93 (88 %)
Within ± 15 mg/dL
17/17 (100 %)
Within ± 15 %
93/93 (100 %)
Obtained by
lay users
1.032
-3.63 mg/dL
0.985
105
67–413 mg/dL
Within ± 20 %
93/93 (100 %)
57