Beurer GL44
31
Control solution functionality
The control solution contains a fixed amount of glucose that reacts with the test strip. A test with
control solution is similar to a blood test. However, control solution is used instead of blood. The
measurement using control solution must be within the result range. This value range is printed on
every test strip box and/or on the information sheet included with the test strips in film packaging.
Chemical composition of the control solution
The control solution is a red solution with the following D-glucose level (in percentage shares).
Substances
LEVEL 3 control solution
LEVEL 4 control solution
D-glucose
0.14% 0.37%
Non-reactive components
99.86% 99.63%
Standards
For the device (including test strips and control solution), the Beurer GL 44 measuring system
complies with the European directive IVD (98/79/EC). The lancet needles comply with the Europe-
an directive MDD (93/42/EC). The lancing device complies with the regulation (EU) MDR (2017/745)
on medical devices.
10 c
omparison
of
measured
values
with
laboratory
values
Precision
Three lots of the GL44 blood glucose test strips have been tested to assess the precision of the
GL44 blood glucose measuring system. This includes a repeat assessment using venous blood and
a laboratory precision assessment using the control material. The blood glucose content of the ve-
nous blood samples ranges from 42.7 to 418.0 mg/dL (2.4 to 23.2 mmol/L) and control material from
three concentrations is used.
Results of the repeat precision measurements
Sample Venous blood
Grand mean value Pooled standard
deviation
Pooled coefficient
of variation (%)
mg/dL
mmol/L mg/dL
mmol/L mg/dL
mmol/L
1
42.7
2.4
36.0
2.0
2.0
0.1
5.6
2
62.0
3.4
59.2
3.3
3.5
0.2
5.9
3
120.5
6.7
127.1
7.1
4.1
0.2
3.2
4
201.0
11.2
213.8
11.9
6.7
0.4
3.1
5
316.5
17.6
329.9
18.3
10.1
0.6
3.1
6
418.0
23.2
433.5
24.1
14.5
0.8
3.3
Содержание GL 44
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