Contour NEXT ONE - System Accuracy and Precision; System Accuracy Results; Repeatability Precision Study

Technical Information: User Accuracy
The CONTOUR NEXT ONE blood glucose monitoring system
was tested by 372 lay users using capillary blood samples and
three C
ONTOUR NEXT test strip lots. The results were compared
to the YSI Glucose Analyzer laboratory reference method,
traceable to the CDC hexokinase method. The following
accuracy results were obtained.
Table 1: System accuracy results for glucose
concentration < 75 mg/dL
¿Ů»È»Ä¹»ȷĽ»¿ÄÌ·ÂË»É
between YSI laboratory
reference method and
C
ONTOUR NEXT ONE meter
Within
± 5
mg/dL
Within
± 10
mg/dL
Within
± 15
mg/dL
Number (and percent) of
É·ÃÆ»ÉͿʾ¿ÄÉÆ»¹¿Ű»º
range
14 of 17
(82.4%)
16 of 17
(94.1%)
17 of 17
(100%)
54