ABX Pentra 80 RAB108EA, User Manual

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Speci fications
Summary of performance data*
Pentra 80 - User Manual - RAB108EA
8–7
3. Summary of performance data*
*(source 510K submission #K024002)
3.1. Precision (Reproducibility)
The Pentra 80 was initially calibrated with ABX MINOCAL (lot Number: MCAL321).
Three levels of PENTRA 5D Hematology Control (ABX Difftrol) material (Lot No: PX52) were
run in duplicate twice daily for 20 days. The results were used to quantify within run preci-
sion, SD of the run means, SD of the daily means, and Total Imprecision in accordance with
the NCCLS EP 5-A Guidelines.
Tab. 8–4: Reproducibility (Standard deviation)
Parameter
Pentra 5D
Hematology
control
Within Run SD
SD of run
Means
SD of Daily
Means
Total
Imprecision
(SD)
WBC
PX052 High 0.67 0.53 0.53 0.81
PX052 Normal 0.11 0.1 0.12 0.16
PX052 Low 0.06 0.04 0.04 0.07
RBC
PX052 High 0.06 0.04 0.05 0.07
PX052 Normal 0.06 0.04 0.04 0.06
PX052 Low 0.03 0.02 0.03 0.04
HGB
PX052 High 0.12 0.07 0.09 0.13
PX052 Normal 0.08 0.08 0.07 0.11
PX052 Low 0.05 0.05 0.04 0.06
HCT
PX052 High 0.76 0.61 0.65 0.95
PX052 Normal 0.62 0.62 0.62 0.88
PX052 Low 0.28 0.34 0.37 0.48
PLT
PX052 High 16.29 8.32 10.6 16.72
PX052 Normal 9.01 5.2 8.64 11.35
PX052 Low 3.61 3.87 4.69 6
Neutro%
PX052 High 1.73 1.2 1.34 2
PX052 Normal 0.76 0.53 0.41 0.77
PX052 Low 0.97 0.8 0.72 1.14
Lympho%
PX052 High 1.79 1.27 1.54 2.19
PX052 Normal 0.86 0.67 0.55 0.94
PX052 Low 1.24 0.72 0.78 1.28
Mono%
PX052 High 0.32 0.25 0.14 0.32
PX052 Normal 0.18 0.09 0.12 0.18
PX052 Low 0.21 0.13 0.08 0.19
Eosino%
PX052 High 0.24 0.14 0.17 0.26
PX052 Normal 0.32 0.29 0.21 0.37
PX052 Low 1.05 0.83 0.48 1.06
Baso%
PX052 High 0.1 0.08 0.09 0.13
PX052 Normal 0.05 0.05 0.03 0.06
PX052 Low 0.1 0.07 0.07 0.11