Glucose: Packed Cell Volume (Haematocrit); Glucose: Precision - A.MENARINI GlucoMen Day METER 2K User Manual

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System accuracy results for glucose concentrations between
32.5 mg/dL and 462.4 mg/dL
/ 10.2

Glucose: Packed Cell Volume (Haematocrit)

The haematocrit levels (15-65 %) were successfully tested to
concentration.
/ 10.3

Glucose: Precision

The precision studies were performed in a laboratory using GlucoMen
Day METER 2K system.
Within Run Precision
*Bloodav 41 mg/dL
*Bloodav 77 mg/dL
*Bloodav 135 mg/dL
*Bloodav 222 mg/dL
*Bloodav 369 mg/dL
Between Run Precision
*Controlav 41 mg/dL
*Controlav 121 mg/dL
*Controlav 349 mg/dL
This study shows that there could be variation of up to 3.0 %.
31
Within ± 15 mg/dL and Within ± 15 %
600/600 (100 %)
®
SD = 1.2 mg/dL
SD = 2.7 mg/dL
CV = 2.8 %
CV = 3.0 %
CV = 3.0 %
SD = 1.2 mg/dL
CV = 2.2 %
CV = 2.8 %