Performance Characteristics - ReliOn Premier VOICE User Manual

Performance Characteristics

The performance of ReliOn™ Premier Voice Blood Glucose
Monitoring System has been evaluated in laboratory and
clinical tests.
Accuracy: The ReliOn™ Premier Voice Blood Glucose Monitoring
System is calibrated to yield results equivalent to plasma glucose
concentrations. The accuracy of the ReliOn™ Premier Voice
System (Model GM505UAA) 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 sample
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%)
54
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%)