54
TECHNICAL,
SER
VICE & CARE
®
55
TECHNICAL,
SER
VICE & CARE
T
echnical Information
Symbols Used
Symbols Used
The following symbols are used throughout the product
labeling for the C
ONTOUR
®
N
EXT
EZ blood glucose
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
Technical Information
The C
ONTOUR
®
N
EXT
EZ blood glucose monitoring
system was tested by 115 lay users using capillary
blood samples and three C
ONTOUR
®
N
EXT
test strip
lots. The results were compared to the YSI
®
Glucose
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
reference method and
C
ONTOUR
N
EXT
EZ meter
Within ±
5 mg/dL
Within ±
10 mg/dL
Within ±
15 mg/dL*
Number (and percent) of
samples within specified
range
6 of 7
(85.7%)
7 of 7
(100.0%)
7 of 7
(100.0%)
Table 2 – System accuracy results for glucose
concentration ≥ 75 mg/dL
Difference range in
values between YSI
®
laboratory reference
method and
C
ONTOUR
®
N
EXT
EZ
meter
Within ±
5%
Within ±
10%
Within ±
15%
Within ±
20%*
Number (and
percent) of samples
within specified
range
83 of 108
(76.9%)
104 of 108
(96.3%)
107 of 108
(99.1%)
108 of 108
(100.0%)
*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.
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