Contour Next GEN 9658 User Manual

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Contour
®
next GEN blood glucose monitoring system
TECHNICAL INFORMATION
Technical Information: User Accuracy
The Contour next GEN meter results may vary slightly from
your actual blood glucose value due to slight dierences in testing
technique and the natural variation in test technology.
The table below
shows the results where typical users enrolled in a clinical study used
the Contour next GEN meter to measure their blood glucose levels.
For example, in this study, the Contour next GEN meter displayed
results within 15% of their actual blood glucose level in 366 out of 371
measurements as compared to an approved lab instrument.
Table 1: System accuracy results for glucose concentrations
across the entire tested range
Dierence range
between the actual
blood glucose
level and the
Contour next Gen
meter result
Within
± 5%
Within
± 10%
Within
± 15%
Within
± 20%
Percent
(and number) of
samples within
specied range
64.96%
(241/371)
93.53%
(347/371)
98.65%
(366/371)
99.19%
(368/371)
Technical Information: Precision
A measurement repeatability study was conducted with the
Contour next GEN blood glucose monitoring system using
5 venous whole blood specimens with glucose levels from
39 mg/dL to 348 mg/dL. With each blood specimen, each of 3 lots
of Contour next test strips was tested 10 times on each of
10 instruments for a total of 300 readings. The following precision
results were obtained.
Table 1: System repeatability results for
Contour next GEN
meter using Contour next test strips
Mean, mg/dL
Pooled Standard
Deviation, mg/dL
95% CI of SD,
mg/dL
Coecient of
Variation, %
40.1 1.1 1.04–1.23 2.8
78.6 1.3 1.21–1.43 1.7
137.5 2.0 1.84–2.18 1.5
212.6 3.3 3.07–3.64 1.6
341.2 4.4 4.02–4.76 1.3

Contour Next GEN 9658 Specifications

General

Brand	Contour
Model	Next GEN 9658
Category	Blood Glucose Meter
Language	English