Traceability:
The test result of HGM-111 blood glucose meter is plasma calibrated by
chemistry analyzer, and the analyzer was calibrated with a NIST traceable
glucose standard solution.
Measurement range:
HGM-111 meter display results between 20 ~ 600 mg/dL.
Accuracy:
The accuracy of the HGM-111 meter was assessed by comparing blood
glucose results obtained by patients with those obtained using clinical
analyzer. The following results were obtained by (200) test numbers.
Chapter 8 HGM-111 Performance Characteristics
Precision:
This study shows the variability from strip to strip in sample tests. The
results are shown in the following table.
Slope
y-intercept mg/dL
Correlation factor (R2)
Test number (n)
Test range mg/dL
12/38 (31.6%) 25/38 (65.8%)
37/38 (97.4%)
Within ± 5 mg/dL Within ± 10 mg/dL Within ± 15 mg/dL
46/162 (28.4%) 103/162 (63.6%) 146/162 (90.1%) 156/162 (96.3%)
Within ± 5 % Within ± 10 % Within ± 15 % Within ± 20 %
Number and % of results within reference (for values were
<
75 mg/dL)
Number and % of results within reference (for values were
≧
75 mg/dL)
-9.0911 mg/dL
0.9797
200
34-550 mg/dL
0.9817
30
BLOOD GLUCOSE MONITORING SYSTEM-HGM-111