10 c – Beurer GL 44 (mg/dL) User Manual
Page 35
Beurer GL44 mg/dL
35
Standards
The Beurer GL44 monitor corresponds to European guidelines IVD (98/79/EC) and MDD (93/42/EC).
10 c
omparison
of
measured
values
with
laboratory
value
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 labora-
tory precision assessment using the control material. The blood glucose content of the venous blood
samples ranges from 42.7 to 418.0 mg/dL and control material from three concentrations is used.
Results of the repeat precision measurements
Sample
Venous blood
(mg/dL)
Grand mean
value (mg/dL)
Pooled standard de-
viation
Pooled coefficient
of variation (%)
1
42,7
36,0
2,0
5,6
2
62,0
59,2
3,5
5,9
3
120,5
127,1
4,1
3,2
4
201,0
213,8
6,7
3,1
5
316,5
329,9
10,1
3,1
6
418,0
433,5
14,5
3,3
Results of the intermediate precision measurement
Sample
Control material
(mg/dL)
Grand mean
value (mg/dL)
Pooled standard
deviation
Pooled coefficient
of variation (%)
1
70,0
71,3
1,0
1,4
2
135,6
136,3
1,4
1,1
3
351,5
350,8
2,8
0,8
System accuracy
The GL44 blood glucose monitor in comparison with the YSI.
Three lots of GL44 blood glucose test strips have been tested to assess the system accuracy of the
GL44 blood glucose measuring system and to compare it with the reference method in which capil-
lary whole blood concentrations of 34.4 to 442.8 mg/dL have been used.