Precision Claims - HORIBA ABX Micros 60 User Manual

Tab.1-6:
MINOTROL 16
Parameter
Control
M243 High
WBC M243 Normal
M243 Low
M243 High
RBC M243 Normal
M243 Low
M243 High
HGB M243 Normal
M243 Low
M243 High
HCT M243 Normal
M243 Low
M243 High
PLT M243 Normal
M243 Low
Evaluation of Precision Performance of Clinical Chemistry Devices; Approved Guidelines, NCCLS doc-
ument EP-5 (ISBN 1-56238-145-8) 1999
*Source 510K submission # K030799

3.2. Precision Claims*

Tab.1-7:
Parameters
WBC
RBC
HGB
HCT
PLT
*Source 510K submission # K030799
Within run CV% of run
CV% means
1.19 1.01
1.39 1.11
3.06 1.68
0.9 0.62
1.02 0.88
1.46 1.07
1.72 1.28
0.85 1.17
1.49 3.5
1.06 1.62
1.51 1.38
1.6 1.6
2.89 1.37
9.17 7.23
5.14 6.87
%CV
<2.5%
<2.0%
<1.5%
<2.0%
<5.0%
ABX Micros
Specifications
Summary of Performance Data
CV% of Daily Total impreci-
means sion (CV%)
0.96 1.46
1.46 1.93
1.93 3.13
0.78 1.1
0.8 1.24
1.15 1.72
2.23 2.7
3.17 3.33
4.65 5.37
1.96 2.39
2 2.47
1.96 2.53
1.91 2.96
5.87 10.13
6.70 9.04
Nominal Values
3
10.0 x 10 /µL
6
5 x 10 /µL
15 g /dL
45 %
3
300 x 10 /µL
60 - User Manual - RAB042FEN - 9