Beurer GL 50 evo (mgdl) User Manual

Page 36

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36

Beurer GL50 evo mg/dL

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 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 %)

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