Woodley InSight Mini Chem, User Manual

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Section 14 Meter Performance
Accuracy
Item Range of Sample Bias
UA 90 – 300 µmol/L (1.51 – 5.04 mg/dL) ≤ ±0.060 mmol/L (±1.01 mg/dL)
301 – 1200 µmol/L (5.05 – 20.17 mg/dL) ≤ ±20%
CR 44 – 150 µmol/L (0.50 – 1.70 mg/dL) ≤ ±0.030 mmol/L (±0.34 mg/dL)
151 – 1320 µmol/L (1.71 – 14.93 mg/dL) ≤ ±20%
UR 0.90 – 10.00 mmol/L (5.41 – 60.06 mg/dL) ≤ ±2.00 mmol/L (±12.01 mg/dL)
10.01 – 40.00 mmol/L (60.07 – 240.24 mg/dL) ≤ ±20%
Precision
Item Range of Sample SD
UA 90 – 300 µmol/L (1.51 – 5.04 mg/dL) SD<0.023 mmol/L (<0.38 mg/dL)
301 – 1200 µmol/L (5.05 – 20.17 mg/dL) CV<7.5%
CR 44 – 150 µmol/L (0.50 – 1.70 mg/dL) SD<0.011 mmol/L (<0.13 mg/dL)
151 – 1320 µmol/L (1.71 – 14.93 mg/dL) CV<7.5%
UR 0.90 – 10.00 mmol/L (5.41 – 60.06 mg/dL) SD<0.75 mmol/L (<4.50 mg/dL)
10.01 – 40.00 mmol/L (60.07 – 240.24 mg/dL) CV<7.5%