EPS Bio Technology EASYMAX Tag User Manual page 51

System Accuracy
The EASYMAX® Tag blood Glucose monitor in comparsion with the YSI. Three lots of
EASYMAX® blood glucose test strips have been tested to assess the system accuracy of the
EASYMAX® Tag 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 of glucose concentrations <100 mg/dL (<5.55 mmol/L)
within±5mg/dL
(Within ± 0.28 mmol/L)
55 / 180
30.6 %
Result of the system accuracy of glucose concentrations ≧100 mg/dL (≧5.55 mmol/L)
within±5％
220 / 438
50.2 %
Results of the system accuracy for combined glucose concentrations between 34.4 mg/dL (1.91
mmol/L) and 442.8 mg/dL (24.60 mmol/L)
Within ± 15 mg/dL or ±15% (Within ± 0.83 mmol/L or ±15%)
within±10mg/dL
(Within ± 0.56 mmol/L)
111 / 180
61.7 %
within±10％
357 / 438
81.5 %
597 / 618 (96.6%)
within±15mg/dL
(Within ± 0.83 mmol/L)
175 / 180
97.2 %
within±15％
422 / 438
96.3 %
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