Arkray Assure PRISM MULTI Reference Manual

SECTION
C
22
Obtained by Healthcare Professionals Obtained by Lay Users
Slope 1.017 1.022
Y-intercept -7.39mg/dL -8.31mg/dL
Correlation
coefcient(r)
0.992 0.992
Number of samples 122 118
Range tested 40-577mg/dL 58-577mg/dL
Precision
Studies were performed in a laboratory using the Assure Prism multi Blood
Glucose Monitoring System.
Within Run Precision
Blood avg.* 41.4mg/dL SD=1.8mg/dL
Blood avg.* 79.6mg/dL SD=2.8mg/dL
Blood avg.* 129.8mg/dL CV = 2.6%
Blood avg.* 201.9mg/dL CV = 3.1%
Blood avg.* 349.6mg/dL CV = 2.7%
Total Precision
Control avg.* 36.2mg/dL SD=1.3mg/dL
Control avg.* 117.0mg/dL CV = 2.3%
Control avg.* 321.8mg/dL CV = 2.4%
* This study shows that there could be variation of up to 3.5%.
ACCURACY AND PRECISION STUDIES
Performance Characteristics
The performance of the Assure Prism multi Blood Glucose Monitoring System has been
evaluated in laboratory and clinical tests.
ACCURACY: The Assure Prism multi Blood Glucose Monitoring System is calibrated to yield
results equivalent to plasma glucose concentrations. The accuracy of the Assure
Prism multi Blood Glucose Monitoring 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.
Accuracy
Results for glucose concentration < 75 mg/dL
Within ± 5 mg/dL Within ± 10 mg/dL Within ± 15 mg/dL
11/11 (100 %) 11/11 (100 %) 11/11 (100 %)
Results for glucose concentration ≥ 75 mg/dL
Within ± 5% Within ± 10% Within ± 15% Within ± 20%
47/111 (42%) 89/111 (80%) 109/111 (98%) 111/111 (100 %)

Arkray Assure PRISM MULTI Specifications

General

Brand	Arkray
Model	Assure PRISM MULTI
Category	Blood Glucose Meter
Language	English