30
Beurer GL43 mg/dL
Results of the intermediate precision measurement
Sample
Control material
(mg/dL)
Grand mean
value (mg/dL)
Pooled standard
deviation
Pooled coefficient
of variation (%)
1
46,2
43,8
2,2
5,1
2
135,0
131,7
3,7
2,8
3
350,0
346,3
8,5
2,4
System accuracy
The GL43 blood glucose monitor in comparison with the YSI.
Three lots of GL43 blood glucose test strips have been tested to assess the system accuracy of the
GL43 blood glucose measuring system and to compare it with the reference method in which capil-
lary whole blood concentrations of 24,8 to 715 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)
116/186 (62.4%)
172/186 (92.5%)
184/186 (98.9%)
Results of the system accuracy for glucose concentrations ≥100 mg/dL (≥5.55 mmol/L)
Within ±5%
Within ±10%
Within ±15%
250/414 (60.4%)
379/414 (91.5%)
413/414 (99.8%)
Results of the system accuracy for combined glucose concentrations between
24,8 mg/dL
(1,4 mmol/L)
and
715 mg/dL (39,7 mmol/L)
.
Within ±15 mg/dL or ±15%
(Within ±0.83 mmol/L or ±15%)
597/600 (99.5%)
In comparison to the YSI, the GL43 met the EN ISO 15197:2015 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 con-
centrations <100 mg/dL (<5.55 mmol/L) or ±15% for blood glucose concentrations of ≥100 mg/dL
(≥5.55 mmol/L). 99% of the individual measured blood glucose values must fall within zones A and
B of the Consensus Error Grid (CEG) for diabetes type 1.
Performance evaluation by the user
A study to assess the glucose values of blood samples of capillary blood from the fingertips, which
were obtained from 150 individuals that had no special training, produced the following results:
