35
Versions 1.0
Section 14 Meter Performance
The Accuracy
Iterm
Range of sample
Bias
UA
0.090mmol/L-0.300mmol/L (1.51mg/dL-5.04mg/dL)
≤±0.060mmol/L
(±1.01mg/dL)
0.301mmol/L-1.200mmol/L (5.05mg/dL-20.17mg/dL) ≤±20%
CR
0.044mmol/L-0.150mmol/L (0.50mg/dL-1.70mg/dL)
≤±0.030mmol/L
(±0.34mg/dL)
0.151mmol/L-1.320mmol/L (1.71mg/dL-14.93mg/dL) ≤±20%
UR
0.90mmol/L-10.00mmol/L (5.41mg/dL-60.06mg/dL)
≤±2.00mmol/L
(±12.01mg/dL)
10.01mmol/L-40.00mmol/L(60.07mg/dL-240.24mg/dL) ≤±20%
The Precision
Iterm
Range of sample
SD
UA
0.090mmol/L-0.300mmol/L(1.51mg/dL-5.04mg/dL)
SD<0.023mmol/L
(<0.38mg/dL)
0.301mmol/L-1.200mmol/L (5.05mg/dL-20.17mg/dL)
CV<7.5%
CR
0.044mmol/L-0.150mmol/L (0.50mg/dL-1.70mg/dL)
SD<0.011mmol/L
(<0.13mg/dL)
0.151mmol/L-1.320mmol/L (1.71mg/dL-14.93mg/dL)
CV<7.5%
UR
0.90mmol/L-10.00mmol/L (5.41mg/dL-60.06mg/dL)
SD<0.75mmol/L
(<4.50mg/dL)
10.01mmol/L-40.00mmol/L(60.07mg/dL-240.24mg/dL)
CV<7.5%
RFM-101 insert 20191125.indd 35
2019/11/27 10:42:08
