38
Beurer GL50 evo
Results of the repeat precision measurements
Sample Venous blood
Overall average
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
Results of the intermediate precision measurement
Sample Control material
Overall average
value
Pooled standard
deviation
Pooled coefficient
of variation (%)
mg/dL
mmol/L mg/dL
mmol/L mg/dL
mmol/L
1
70.0
3.9
71.3
4.0
1.0
0.1
1.4
2
135.6
7.5
136.3
7.6
1.4
0.1
1.1
3
351.5
19.5
350.8
19.5
2.8
0.2
0.8
System accuracy
The GL50 evo blood glucose monitor in comparison to the YSI.
Three lots of GL50 evo blood glucose test strips have been tested to assess the system accuracy
of the GL50 evo blood glucose monitoring system and to compare it with the reference method, in
which capillary whole blood concentrations of 36.0 mg/dL (2.0 mmol/L) to 442.5 mg/dL (24.6 mmol/L)
have been used.
Results of the system accuracy for glucose concentrations <100 mg/dL (<5.55 mmol/L)
Within ±5 mg/dL
(Within ±0.28 mmol/L)
Within ±10mg/dL
(Within ±0.56 mmol/L)
Within ±15mg/dL
(Within ±0.83 mmol/L)
101/168 (60.12%)
161/168 (95.83%)
166/168 (98.81%)
Results of the system accuracy for glucose concentrations ≥100 mg/dL (≥5.55 mmol/L)
Within ±5%
Within ±10%
Within ±15%
182/432 (42.13%)
358/432 (82.87%)
426/432 (98.61%)
