Beurer GL 50 - System Accuracy Evaluation

36 Beurer GL50 evo mg/dL
Sample Venous blood
(mg/dL)
Grand mean
value (mg/dL)
Pooled standard de-
viation
Pooled coecient
ofvariation (%)
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 coecient
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 GL50 evo blood glucose monitor in comparison with 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 measuring system and to compare it with the reference method in which
capillary whole blood concentrations of 34.4 to 442.8 mg/dL have been used.
Result of the system accuracy for glucose concentrations <100 mg/dL (<5.55 mmol/L)
Within ±5 mg/dL
(Within ±0.28 mmol/L)
Within ±10 mg/dL
(Within ±0.56 mmol/L)
Within ±15 mg/dL
(Within ±0.83 mmol/L)
55/180 (30,6%) 111/180 (61,7%) 175/180 (97,2%)
Results of the system accuracy for glucose concentrations ≥100 mg/dL (≥5.55 mmol/L)
Within ±5% Within ±10% Within ±15%
220/438 (50,2%) 357/438 (81,5%) 422/438 (96,3%)
Results of the system accuracy for combined glucose concentrations between 34.4 mg/dL
(1.9 mmol/L) and 442.8 mg/dL (24.6 mmol/L).
Within ±15 mg/dL or ±15%
(Within ±0.83 mmol/L or ±15%)
597/618 (96,6%)
In comparison to the YSI, the GL50 evo met the EN ISO 15197:2013 standard, whereby 95% of the
blood glucose values measured have to fall within the following zones: either ±0.83 mmol/L (±15 mg/
dL) of the measured average value when using the reference measuring procedure for blood glucose
concentrations <100 mg/dL (<5.55 mmol/L) or ±15% for blood glucose concentrations of ≥100 mg/