Clinical Site Studies
Number of Samples:
127
Range:
39 mg/dL to 496 mg/dL
Slope:
1.037
Intercept:
-4.68 mg/dL
Correlation Coefficient:
0.988
Precision
Precision describes the variation between readings in the test system. A test system with
little variation is defined as precise. A study was conducted with the GlucoSure
®
Plus
Blood Glucose Monitoring System using five heparinized blood specimens with
concentrations ranging from 43 mg/dL to 378 mg/dL. Multiple replicates (n=20) were
tested using multiple GlucoSure
®
Plus Blood Glucose meters and one lot of Touch-In
®
Plus Blood Glucose Test Strips. The following precision results were obtained.
35
USER'S GUIDE
Chapter 9.
Performance Evaluations
