Symbols Used; Technical Information - Bayer HealthCare Contour Next EX User Manual

Symbols Used

The following symbols are used throughout the product
labeling for the C
ONTOUR
monitoring system (meter packaging and labeling, and
reagent and control solution packaging and labeling).
Batch code
Use by Date (last day of month)
Consult instructions for use
In Vitro Diagnostic Medical Device
®
54
® N EZ blood glucose
EXT

Technical Information

The C ® N EZ blood glucose monitoring
ONTOUR EXT
system was tested by 115 lay users using capillary
blood samples and three C
ONTOUR
lots. The results were compared to the YSI
Analyzer laboratory reference method, traceable to the
CDC hexokinase method. The tables below show how
well the two methods compared.
Table 1 – System accuracy results for glucose
concentration < 75 mg/dL
Difference range in values
between YSI laboratory Within ±
reference method and 5 mg/dL
C N EZ meter
ONTOUR EXT
Number (and percent) of
samples within specified
(85.7%)
range
Table 2 – System accuracy results for glucose
concentration ≥ 75 mg/dL
Difference range in
values between YSI ®
Within ±
laboratory reference
method and 5%
C ® N EZ
ONTOUR EXT
meter
Number (and
percent) of samples 83 of 108
within specified
(76.9%)
range
*Acceptance criteria in ISO 15197: 2003 are that 95% of all
differences in glucose values (i.e., between reference method
and meter) should be within 15 mg/dL for glucose values less
than 75 mg/dL, and within 20% for glucose values greater than
or equal to 75 mg/dL.
®
N test strip
EXT
®
Glucose
Within ± Within ±
10 mg/dL 15 mg/dL*
6 of 7 7 of 7 7 of 7
(100.0%) (100.0%)
Within ± Within ± Within ±
10% 15% 20%*
104 of 108 107 of 108 108 of 108
(96.3%) (99.1%) (100.0%)
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