Precision (Repeatability); Linearity - HORIBA ABX Micros 60 User Manual

ABX Micros

3.3. Precision (Repeatability)

Based on 20 consecutive samplings from 1 Fresh Normal Whole Blood, without any alarms.
Tab.1-8:
Precision Table: N = 20
Parameters
WBC
RBC
HGB
HCT
PLT

3.4. Linearity*

◆Linearity range: The Manufacturer's tested linearity zone of the instrument using linearity kits
and/or human blood.
◆Linearity limits: Maximum and minimum values within the instrument returns no dilution
alarm.
◆Visible Range: Range values given by the instrument. These values (above linearity limits)
are given as an indication. They are given associated with a «D» flag. This Visible range is out-
side Manufacturer's range.
◆Linearity Kits: Linearity was tested using available «Low Range» and «Full Range» Linearity
Test kits. The Test kits were analyzed and data was computed according to the Manufacturer's
instructions.
◆Human Blood: Linearity was also obtained on human blood, using a minimum of 5 dilution
point. The results of this study are as followed
Tab.1-9:
Parameters
3
WBC (10 /mm
6
RBC (10 /mm
3
PLT (10 /mm
3
PLT (10 /mm
HGB (g/dL)
HCT (%)
*Source 510K submission # K030799
A: for HGB> 2 g/dL and RBC>0.5x10
B: for HGB< 2 g/dL and RBC>0.5x10
10 - RAB042FEN - User Manual -
60
%CV
<2.5%
<2.0%
<1.5%
<2.0%
<5.0%
Linearity Range Linearity limits Visible Range
3
) 0.5 - 122 0 - 100
3
) 0.2 - 8.7 0 - 8
3
) (A) 10 - 2327 0 - 2200
3
) (B) 25 - 4990 0 - 4000
2.0 - 27 0 - 26
1.8 - 82.3 0 - 80
6
/mm
6
/mm
ABX Micros
Test Level
3
10.0 x 10
6
5 x 10 /µL
15 g /dL
45 %
3
300 x 10
Error limit
(Which ever is greater)
100 - 150 ± 0.3
8 - 18 ± 0.07
2200 - 6000 ± 10
4000 - 6000 ± 10
26 - 30 ± 0.3
80 - 90 ± 2.0
3
3
60
/µL
/µL
± 5 %
± 3 %
± 10%
± 10%
± 3 %
± 3 %