Design Verification

HumaCount 80TS

Content

1. Introduction ...................................................................................................................................................................... 2
2. Summary of Parameters and Evaluations ...................................................................................................................... 2
Specifications for primary parameters: ..................................................................................................................................................3
3. Repeatability ..................................................................................................................................................................... 3
3.1 Evaluation Description.................................................................................................................................................................3
3.2 Data Description ............................................................................................................................................................................3
3.3 Results ................................................................................................................................................................................................4
3.4 Conclusion ........................................................................................................................................................................................5
4. Linearity ............................................................................................................................................................................. 5
4.1 Evaluation Description.................................................................................................................................................................5
4.2 Data Description ............................................................................................................................................................................6
4.3 Results: Linearity Results for Instrument 000004 .............................................................................................................7
4.4 Conclusions ................................................................................................................................................................................... 11
5 Carryover ......................................................................................................................................................................... 11
5.1 Evaluation Description.............................................................................................................................................................. 11
5.2 Data Description ......................................................................................................................................................................... 11
5.3 Results ............................................................................................................................................................................................. 12
5.4 Conclusion ..................................................................................................................................................................................... 13
6. Long Term Precision ........................................................................................................................................................ 13
6.1 Evaluation Description.............................................................................................................................................................. 13
6.2 Data Description ......................................................................................................................................................................... 13
6.3 Results ............................................................................................................................................................................................. 13
6.4 Conclusions ................................................................................................................................................................................... 16
7 Method Comparison of HumaCount 80TS Hematology Analyzer vs. Cell-Dyn 3700 ............................................... 16
7.1 Evaluation Description.............................................................................................................................................................. 16
7.2 Data Description ......................................................................................................................................................................... 18
7.3 Results ............................................................................................................................................................................................. 18
7.4 Conclusions ................................................................................................................................................................................... 28
8 Overall Conclusions ........................................................................................................................................................ 28

Form 4.2-01.06-04 1/28

HC 80TS Rev. 001 | valid of 11.09.2015
1. Introduction
The HumaCount 80TS, a 3-part WBC differential hematology analyzer, uses impedance method for cell
counting and the hemoglobin concentration was measured by photometric method (540nm). The
analyzer can process 80 samples per hour (open tubes), measures and calculates 22 parameters, providing
complete blood counts (CBC) and 3-part differential leukocyte counts (LYM#, LYM%, GRA#, GRA%, MID#,
MID%).

2. Summary of Parameters and Evaluations

The HumaCount 80TS produces the following 22 parameters:

Parameter 80TS Method

White Blood Cell count WBC Impedance measurement
Lymphocyte absolute count LYM Calculated
Mid Cells absolute count MID Calculated
Granulocyte absolute count GRA Calculated
Lymphocyte percentage LYM Derived
Mid Cells percentage MID Derived
Granulocyte percentage GRA Derived
Red Blood Cell count RBC Impedance measurement
Hemoglobin HGB Photometric measurement
Hematocrit HCT Calculated
Mean Corpuscular Volume MCV Derived
Mean Corpuscular Hemoglobin MCH Calculated
Mean Corpuscular Hemoglobin
MCHC Calculated
Concentration
Red Blood cells Distribution Width RDWcv Derived

Red Blood cells Distribution Width RDWsd Derived

Platelet count PLT Impedance measurement
Platelet percentage PCT Calculated
Mean Platelet Volume MPV Derived
Platelet Distribution Width PDWcv Derived
Platelet Distribution Width PDWsd Derived
Platelet large cell concentration P-LCC Calculated
Platelet large cell ratio P-LCR Calculated

The HumaCount 80TS parameters can be classified as follows:

Ref Parameter Type Description Parameters

Impedance or photometric measurement parameters
Direct
that directly measure the absolute concentration of a
1 Measurement WBC, RBC, HGB, PLT
specific cell type using an impedance measurement
Absolute
technology
Derived parameters were statistically calculated from LYM%, MID%, GRA%,
2 Derived the histograms generated by the measurement of MCV, RDWcv, RDWsd,
directly measured parameters MPV, PDWcv, PDWsd
Calculated parameters were mathematical functions of LYM, MID, GRA, HCT,
3 Calculated directly measured, photometrically measured, and MCH, MCHC, PCT, P-LCC,
derived parameters P-LCR

Design Verification and Product Data for HumaCount 80TS 2/28

Rev. 001
 Specifications for primary parameters:
Characteristics Accuracy Reproducibilit Reproducibilit Carry-over Linearity range Unit
Parameter y (CV [%]) y (SD sample to
sample [%]
3
WBC 0.3 or 6% 2.7 0.18 1 0...75 10 /µL
6
RBC 0.15 or 6% 1.7 0.11 1 0...8 10 /µL
HGB 0.3 or 6% 2.0 0.20 1 1...25 g/dL
MCV or 6% 1.7 1.00 n.a. n.a. fl
RDWcv 1.0 or 6% 2.5 0.40 n.a. n.a. %
3
PLT 15 or 8% 6 23.0 1 0...1000 10 /µL
MPV 1.0 or 10% 8.7 0.45 n.a. n.a. fl

3. Repeatability

3.1 Evaluation Description

The repeatability evaluation was conducted against the primary measured parameters (WBC, RBC, HGB,
and PLT) and derived parameters (GRA%, LYM%, MID%, MCV, RDWcv, MPV).
A set of whole human blood samples and control material samples were run on an instruments.
For each sample, 21 replicates were run for each sample. The mean, standard deviation (SD) and
coefficient of variation (CV) was calculated for each applicable parameter. If the measured SD was less
than the SD criteria, or if the measured CV was less than the CV criteria, then the parameter was
considered passing. If all applicable parameters pass for a sample run, then the evaluation of the sample
was considered passing.
Instrument 000004 was selected for repeatability evaluation.

3.2 Data Description

Repeatability samples were selected to be close to the extremes of the reportable range and to be close to
clinical decision levels for the primary measured parameters.
15 human blood samples and three levels of control material were run on instrument 000004.
The control material used in this evaluation was HC-Control of LOT B081.
The following table shows the required distribution of human blood samples and the actual distribution
achieved. Please note that the total number of samples in a given row may be higher than the actual
number of samples run due to overlap in the allowable ranges. A given sample may be represented in
more than one overlapping range.

Low High
Low Clinical High Clinical
Parameter Units Instrument Reportable Normal Range Reportable
Decision Point Decision Point
Range Range
Samples Needed 2 samples 2 samples 4 samples 2 samples 2 samples
3 < 2.0 ≥3.2 and≤4.8 ≥ 4.0 and ≤ 11.3 ≥ 9.0 and ≤13.6 > 60
WBC 10 /µL
000004 2 2 5 3 2
6 < 2.0 ≥ 2.9 and ≤ 4.8 ≥ 3.8 and ≤ 6.5 ≥ 5.2 and ≤ 7.8 > 7.5
RBC 10 /µL
000004 3 7 7 2 3
≥ 8.6 and
< 5.0 ≥ 11.5 and ≤ 17.5 ≥ 14.9 and ≤ 20.1 > 18.5
HGB g/dL ≤ 14.4
000004 2 7 5 3 3
≥ 120 and
< 50 ≥150 and ≤ 450 ≥ 360 and ≤ 540 > 900
PLT 103/µL ≤ 180
000004 3 6 7 2 2

The required minimum quantity and parameter distribution of human blood samples were met.

Design Verification and Product Data for HumaCount 80TS 3/28

Rev. 001
3.3 Results
The following table shows the repeatability results for 15 human blood samples on instrument 000004:

Repeatability Evaluation Instrument 000004 - Human Blood Samples

Parameter WBC LYM% MID% GRA% RBC HGB MCV RDWcv PLT MPV Overall
Units 103/µl % % % 106/µl g/dl fl % 103/µl fl
SD Criteria 0.18 3.10 2.00 3.50 0.11 0.20 1.00 0.40 23.00 0.45
CV Criteria 2.7% 1.7% 2.0% 1.7% 2.5% 6.0% 8.7%
Mean 5.94 21.9 7.37 70.77 3.94 11.33 89.9 14.88 407.14 9.58
20452 SD 0.12 1.51 0.97 1.22 0.04 0.1 0.7 0.24 10.79 0.2
Pass
n=21 CV 2.10% 6.88% 13.15% 1.72% 1.07% 0.84% 0.78% 1.58% 2.65% 2.10%
P/F Status Pass Pass Pass Pass Pass Pass Pass Pass Pass Pass
Mean 9.65 14.0 13.13 72.87 3.49 10.53 88.33 15.85 168 10.93
20426 SD 0.12 0.62 1.09 1.08 0.05 0.11 0.73 0.23 4.24 0.4
Pass
n=21 CV 1.26% 4.42% 8.32% 1.48% 1.29% 1.09% 0.83% 1.45% 2.53% 3.67%
P/F Status Pass Pass Pass Pass Pass Pass Pass Pass Pass Pass
Mean 4.94 25.43 11.06 63.51 5.89 15.9 86.57 16.04 150.57 10.74
452 SD 0.1 1.14 0.75 0.81 0.07 0.09 0.75 0.23 5.78 0.55
Pass
n=21 CV 1.98% 4.47% 6.79% 1.28% 1.22% 0.54% 0.86% 1.43% 3.84% 5.12%
P/F Status Pass Pass Pass Pass Pass Pass Pass Pass Pass Pass
Mean 3.87 58.72 10.95 30.31 4.74 13.44 82.24 14.22 397.24 8.9
21013 SD 0.17 1.82 1.7 1.39 0.07 0.17 0.77 0.22 10.19 0.19
Pass
n=21 CV 4.36% 3.09% 15.54% 4.59% 1.40% 1.28% 0.93% 1.57% 2.56% 2.09%
P/F Status Pass Pass Pass Pass Pass Pass Pass Pass Pass Pass
Mean 64.87 84.89 5.88 9.24 4.53 14.09 92.19 14.63 130.33 7.07
20488 SD 0.59 2.8 2.25* 1.28 0.06 0.16 0.68 0.17 6.57 0.3
Pass
n=21 CV 0.91% 3.30% 38.30% 13.83% 1.37% 1.13% 0.74% 1.17% 5.04% 4.20%
P/F Status Pass Pass Pass Pass Pass Pass Pass Pass Pass Pass
Mean 6.69 28.83 5.22 65.94 7.85 19.4 82.19 14.5 175.43 9.33
27 SD 0.11 0.82 1.3 1.53 0.13 0.17 0.51 0.22 6.63 0.4
Pass
n=21 CV 1.67% 2.84% 24.96% 2.32% 1.68% 0.89% 0.62% 1.55% 3.78% 4.30%
P/F Status Pass Pass Pass Pass Pass Pass Pass Pass Pass Pass
Mean 11.37 27.47 2.08 70.45 7.99 20.54 93.67 14.01 137.1 11.38
78 SD 0.15 0.8 0.58 0.68 0.08 0.1 0.48 0.18 8.79 0.55
Pass
n=21 CV 1.31% 2.90% 27.96% 0.96% 1.06% 0.50% 0.52% 1.27% 6.41% 4.81%
P/F Status Pass Pass Pass Pass Pass Pass Pass Pass Pass Pass
Mean 19.42 22.69 6.29 71.04 3.9 10.17 74.43 24.08 1083.52 10.44
831 SD 0.26 0.81 0.84 1.07 0.04 0.08 1.21 0.49 19.45 0.3
Pass
n=21 CV 1.35% 3.56% 13.34% 1.51% 1.12% 0.83% 1.62% 2.02% 1.80% 2.87%
P/F Status Pass Pass Pass Pass Pass Pass Pass Pass Pass Pass
Mean 0.93 NA1 NA1 NA1 1.76 8.27 97 17.7 38.76 8.1
807 SD 0.06 NA NA NA1 0.03 0.08 0.71 0.32 2.98 0.5
Pass
n=21 CV 6.28% NA1 NA1 NA1 1.44% 0.96% 0.73% 1.83% 7.69% 6.22%
P/F Status Pass Pass Pass Pass Pass Pass Pass Pass Pass Pass
Mean 0.42 NA1 NA1 NA1 1.76 4.18 98.71 17.84 37.24 7.69
209 SD 0.05 NA1 NA1 NA1 0.02 0.04 0.78 0.29 4.11 0.53
1 1 Pass
n=21 CV 12.18% NA NA NA1 1.40% 1.05% 0.79% 1.64% 11.04% 6.85%
P/F Status Pass Pass Pass Pass Pass Pass Pass Pass Pass Pass
Mean 10.06 22.86 6.79 70.36 6.13 17.15 89.86 14.62 167.38 8.62
44 SD 0.24 1.24 1.12 0.83 0.05 0.16 0.57 0.13 6.53 0.24
Pass
n=21 CV 2.34% 5.41% 16.43% 1.18% 0.76% 0.93% 0.64% 0.92% 3.90% 2.74%
P/F Status Pass Pass Pass Pass Pass Pass Pass Pass Pass Pass
Mean 69.04 8.26 8.79 82.94 3.88 12.52 91.05 19.16 219.52 8.44
814 SD 1.07 0.25 1.25 1.42 0.07 0.12 0.59 0.24 7.81 0.44
Pass
n=21 CV 1.54% 3.07% 14.24% 1.71% 1.90% 1.00% 0.65% 1.27% 3.56% 5.17%
P/F Status Pass Pass Pass Pass Pass Pass Pass Pass Pass Pass
79 Mean 18.98 6.44 1.18 92.4 1.76 4.49 95.14 15.56 1028 11.05
Pass
n=21 SD 0.28 0.56 0.4 0.82 0.03 0.04 0.48 0.31 15.17 0.22

Design Verification and Product Data for HumaCount 80TS 4/28

Rev. 001
 CV 1.47% 8.66% 34.32% 0.89% 1.74% 0.80% 0.50% 1.98% 1.48% 2.04%
P/F Status Pass Pass Pass Pass Pass Pass Pass Pass Pass Pass
Mean 4.35 25.06 9.12 65.83 4.09 11.14 84.57 17.08 182.43 10.85
262 SD 0.13 1.05 1.23 1.89 0.06 0.13 0.68 0.27 6.82 0.43
Pass
n=21 CV 2.96% 4.21% 13.52% 2.87% 1.47% 1.19% 0.80% 1.60% 3.74% 3.95%
P/F Status Pass Pass Pass Pass Pass Pass Pass Pass Pass Pass
Mean 9.19 35.8 2.06 62.15 8.19 20.9 88.38 15.1 131.14 11
87 SD 0.22 0.46 0.45 0.77 0.14 0.13 0.5 0.2 7.57 0.61
Pass
n=21 CV 2.36% 1.27% 21.72% 1.23% 1.67% 0.61% 0.56% 1.32% 5.77% 5.52%
P/F Status Pass Pass Pass Pass Pass Pass Pass Pass Pass Pass
*outlier, accepted

The following table shows the repeatability results for 3 levels of control material on instrument 000004:
Repeatability Evaluation Instrument 000004 - Controls Samples
RDWc
Parameter WBC LYM% MID% GRA% RBC HGB MCV v PLT MPV Overall
Units 103/µl % % % 106/µl g/dl fl % 103/µl fl
SD Criteria 0.18 3.10 2.00 3.50 0.11 0.20 1.00 0.40 23.00 0.45
CV Criteria 2.7% 1.7% 2.0% 1.7% 2.5% 6.0% 8.7%
Mean 1.93 59.26 10.92 29.8 2.46 6.27 81.81 17.98 63.86 7.44
SD 0.05 1.73 1.25 1.48 0.03 0.09 0.51 0.25 3.51 0.55
Diacon3
2.91 11.42 1.44 7.40 Pass
B081/L 2.78% 4.97% 1.41% 0.63% 1.41% 5.50%
CV % % % %
P/F Status Pass Pass Pass Pass Pass Pass Pass Pass Pass Pass
228.2
7 30.95 5.86 63.19 4.87 13.7 93.9 16.54 7.2
Mean 4
Diacon3 SD 0.12 0.81 0.36 0.64 0.08 0.18 0.3 0.14 7.87 0.25
Pass
B081/N 2.61 1.31 3.44
1.70% 6.19% 1.01% 1.60% 0.32% 0.87% 3.45%
CV % % %
P/F Status Pass Pass Pass Pass Pass Pass Pass Pass Pass Pass
103.7 460.4
18.71 12.47 4.45 83.08 6.05 18.36 15.62 7.57
Mean 6 8
Diacon3 SD 0.22 0.31 0.19 0.36 0.07 0.09 0.44 0.15 9.73 0.22
Pass
B081/H 2.49 0.47 2.88
1.19% 4.18% 0.43% 1.13% 0.42% 0.99% 2.11%
CV % % %
P/F Status Pass Pass Pass Pass Pass Pass Pass Pass Pass Pass

3.4 Conclusion
All repeatability runs had the required maximum number of replicates (21) as per the protocol. The
required number and parameter distribution of human blood samples were run. Three levels of controls
were run as required. All repeatability runs passed either their CV or SD criteria for all parameters for both
instruments. Therefore, the repeatability performance of the HumaCount 80TS Analyzer was considered
passing.

4. Linearity

4.1 Evaluation Description

The 4 primary measured parameters (WBC, RBC, HGB, and PLT) were selected for evaluation of linearity.
For each parameter, a low and high dilution sample was prepared with concentrations close to the low
and high reportable range of each parameter. The low and high concentration sample may be an artificial
linearity control material, or human blood samples manipulated to increase and/or reduce parameter
concentration.

Design Verification and Product Data for HumaCount 80TS 5/28

Rev. 001
7 to 11 dilutions had been used (1 low concentration sample, 1 high concentration sample, and 5-9
intermediate proportional dilutions) for each parameter, and 2-4 replicates per dilution were measured.
The statistical analysis ensures that there were no statistically significant higher-order coefficients, and if
there were, observed nonlinearities between the linear model and the best-fit higher order model were
compared to maximum nonlinearity criteria for each of the five dilutions. A pooled repeatability estimate
2
was checked against repeatability criteria, and finally, the coefficient of correlation (r ) values were
checked against minimum criteria.
A parameter was considered passing if the results for both instruments pass the statistical tests described
above. The linearity evaluation was considered passing if all four parameters pass.
Instruments 000004 was selected for this linearity evaluation.

4.2 Data Description

9 dilutions were used for the determination of linearity for WBC. 11 dilutions were used for the
determination of linearity for PLT, RBC and HGB. The following tables describe the concentrations and
sample types of the high and low sample, the intermediate dilutions, and the reportable ranges for each
parameter (WBC RBC, HGB and PLT).

Dilution WBC RBC HGB PLT

3 6 3
Number (10 /µl) (10 /µl) (g/dl) (10 /µl)
Linearity Linearity Linearity Linearity
Sample Type
Material Material Material Material
Low Concentration Sample 1 0.9 0.45 1.5 13
Dilution 2 2 9.9 1.26 4.1 122
Dilution 3 3 19.2 2.09 6.6 226
Dilution 4 4 28.4 2.89 9. 330
Dilution 5 5 38.5 3.76 11.5 439
Dilution 6 6 47.6 4.62 14.1 551
Dilution 7 7 57.8 5.49 16.6 651
Dilution 8 8 67.4 6.36 19 762
Dilution 9 9 77.7 7.16 21.5 877
Dilution 10 10 - 8.16 24.1 976
High Concentration Sample 11 - 8.99 26.4 1064
Low Reportable Range 0 0 1 0
High Reportable Range 75 8 25 1000

Design Verification and Product Data for HumaCount 80TS 6/28

Rev. 001
4.3 Results: Linearity Results for Instrument 000004

4.3.1 WBC Linearity

2
r (>) 0.95 Absolute Percent Preparations 9
Criteria Repeatability 0.18 2.70% Replicates 3
Nonlinearity 0.80 3.00%
Dilution Ref Rep 1 Rep 2 Rep 3 Rep 4 Mean SD
1 1.000 0.85 0.87 0.92 -- 0.880 0.036
2 2.000 9.98 10.15 10.07 -- 10.067 0.085
3 3.000 19.28 19.05 19.23 -- 19.187 0.121
4 4.000 28.09 28.97 28.33 -- 28.463 0.455
5 5.000 38.54 38.27 39.02 -- 38.610 0.380
6 6.000 48.42 47.77 47.53 -- 47.907 0.460
7 7.000 57 58.19 57.45 -- 57.547 0.601
8 8.000 67.72 67.57 65.9 -- 67.063 1.010
9 9.000 79.18 78.4 78.9 -- 78.827 0.395
10 -- -- -- -- -- -- --
11 -- -- -- -- -- -- --

Regression Analysis
2
Order Coef. Value Coef. SE t Critical t P Value SEreg r
st
1 b0 -9.517 0.344 -27.698 2.060 0.000 -- --
st
1 b1 9.649 0.061 158.024 2.060 0.000 0.8192 0.9990
nd
2 b0 -7.784 0.438 -17.782 2.064 0.000 -- --
nd
2 b1 8.704 0.201 43.302 2.064 0.000 -- --
nd
2 b2 0.095 0.020 4.822 2.064 0.000 0.5959 0.9995
rd
3 b0 -8.818 0.712 -12.393 2.069 0.000 -- --
rd
3 b1 9.694 0.583 16.614 2.069 0.000 -- --
rd
3 b2 -0.140 0.132 -1.063 2.069 0.299 -- --
rd
3 b3 0.016 0.009 1.797 2.069 0.085 0.5700 0.9996

Design Verification and Product Data for HumaCount 80TS 7/28

Rev. 001
 Linearity Mean Values vs. 1st and 3rd Order Prediction
90
WBC Set 1
80
1st and 3rd Order Prediction

70

60

50

40

30

20

10

0
0 10 20 30 40 50 60 70 80 90
Mean Values

Mean vs. 1st Order Prediction Mean vs. 3rd Order Prediction Identity

4.3.2 RBC Linearity

2
r (>) 0.95 Absolute Percent Preparations 11
Criteria Repeatability 0.11 1.70% Replicates 4
Nonlinearity 0.20 3.00%
Dilution Ref Rep 1 Rep 2 Rep 3 Rep 4 Mean SD
1 1.000 1.000 0.46 0.44 0.44 0.45 0.448
2 2.000 2.000 1.28 1.25 1.3 1.24 1.268
3 3.000 3.000 2.07 2.1 2.11 2.1 2.095
4 4.000 4.000 2.89 2.83 2.89 2.85 2.865
5 5.000 5.000 3.78 3.81 3.74 3.76 3.773
6 6.000 6.000 4.5 4.58 4.54 4.65 4.568
7 7.000 7.000 5.39 5.45 5.46 5.41 5.428
8 8.000 8.000 6.28 6.24 6.18 6.38 6.270
9 9.000 9.000 7.08 7.03 6.98 7.06 7.038
10 10.000 10.000 8.01 8.11 8.22 8.09 8.108
11 11.000 11.000 8.9 8.86 8.93 8.94 8.908
Regression Analysis
2
Order Coef. Value Coef. SE t Critical t P Value SEreg r
st
1 b0 -0.455 0.025 -18.318 2.018 0.000 -- --
st
1 b1 0.845 0.004 230.671 2.018 0.000 0.0768 0.9992
nd
2 b0 -0.329 0.035 -9.381 2.020 0.000 -- --
nd
2 b1 0.787 0.013 58.551 2.020 0.000 -- --
nd
2 b2 0.005 0.001 4.442 2.020 0.000 0.0639 0.9995
rd
3 b0 -0.383 0.056 -6.810 2.021 0.000 -- --
rd
3 b1 0.831 0.039 21.416 2.021 0.000 -- --
rd
3 b2 -0.004 0.007 -0.549 2.021 0.586 -- --
rd
3 b3 0.000 0.000 1.221 2.021 0.229 0.0635 0.9995

Design Verification and Product Data for HumaCount 80TS 8/28

Rev. 001
 Linearity Mean Values vs. 1st and 3rd Order Prediction
1st and 3rd Order Prediction 10 RBC Set 2
8
6
4
2
0
0 1 2 3 4 5 6 7 8 9 10
Mean Values

Mean vs. 1st Order Prediction Mean vs. 3rd Order Prediction Identity

4.3.3 HGB Linearity

2
r (>) 0.95 Absolute Percent Preparations 11
Criteria Repeatability 2 2.00% Replicates 4
Nonlinearity 2.7 3.00%
Dilution Ref Rep 1 Rep 2 Rep 3 Rep 4 Mean SD
1 1.000 15.14 14.63 15.65 15.14 15.140 0.416
2 2.000 41.27 41.04 41.11 40.65 41.018 0.263
3 3.000 65.71 66.54 66.32 66.55 66.280 0.395
4 4.000 90.5 90.23 90.53 90.06 90.330 0.225
5 5.000 115.18 115.83 115.17 115.13 115.328 0.336
6 6.000 139.69 139.35 141.32 142.64 140.750 1.525
7 7.000 164.57 166.08 166.24 163.69 165.145 1.228
8 8.000 187.93 190.86 187.55 189.22 188.890 1.495
9 9.000 212.95 213.39 211.36 214.59 213.073 1.336
10 10.000 239.82 238.17 239.47 237.12 238.645 1.240
11 11.000 261.24 260.41 262.66 258.58 260.723 1.704
Regression Analysis
2
Order Coef. Value Coef. SE t Critical t P Value SEreg r
st
1 b0 -8.011 0.428 -18.710 2.018 0.000 -- --
st
1 b1 24.598 0.063 389.626 2.018 0.000 1.3243 0.9997
nd
2 b0 -10.148 0.609 -16.656 2.020 0.000 -- --
nd
2 b1 25.584 0.233 109.638 2.020 0.000 -- --
nd
2 b2 -0.082 0.019 -4.339 2.020 0.000 1.1095 0.9998
rd
3 b0 -9.892 0.993 -9.958 2.021 0.000 -- --
rd
3 b1 25.373 0.686 37.009 2.021 0.000 -- --
rd
3 b2 -0.040 0.130 -0.308 2.021 0.759 -- --
rd
3 b3 -0.002 0.007 -0.328 2.021 0.745 1.1218 0.9998

Design Verification and Product Data for HumaCount 80TS 9/28

Rev. 001
 Linearity Mean Values vs. 1st and 2nd Order Prediction
HGB Set
300
1st and 2nd Order Prediction
200

100

0
0 50 100 150 200 250 300
Mean Values

Mean vs. 1st Order Prediction Mean vs. 2nd Order Prediction Identity

4.3.4 PLT Linearity

2
r (>) 0.95 Absolute Percent Preparations 11
Criteria Repeatability 23.00 6.00% Replicates 3
Nonlinearity 35.00 3.00%
Dilution Ref Rep 1 Rep 2 Rep 3 Rep 4 Mean Dilution
1 1 12 11 14 -- 12.333 1
2 2 122 139 129 -- 130.000 2
3 3 243 244 238 -- 241.667 3
4 4 348 344 365 -- 352.333 4
5 5 468 462 475 -- 468.333 5
6 6 586 583 592 -- 587.000 6
7 7 692 709 670 -- 690.333 7
8 8 790 792 818 -- 800.000 8
9 9 945 919 960 -- 941.333 9
10 10 1051 1042 1053 -- 1048.667 10
11 11 1126 1159 1154 -- 1146.333 11

Regression Analysis
Order Coef. Value Coef. SE t Critical t P Value Order Coef.
st
1 b0 -101.661 4.813 -21.121 2.040 0.000
st
1 b1 114.191 0.710 160.906 2.040 0.000 12.8919 0.9988
nd
2 b0 -99.933 8.300 -12.040 2.042 0.000 -- --
nd
2 b1 113.394 3.179 35.670 2.042 0.000 -- --
nd
2 b2 0.066 0.258 0.257 2.042 0.799 13.0905 0.9988
rd
3 b0 -93.803 13.536 -6.930 2.045 0.000 -- --
rd
3 b1 108.330 9.342 11.596 2.045 0.000 -- --
rd
3 b2 1.077 1.770 0.609 2.045 0.548 -- --
rd
3 b3 -0.056 0.097 -0.577 2.045 0.568 13.2385 0.9988

Design Verification and Product Data for HumaCount 80TS 10/28

Rev. 001
 Linearity Mean Values vs. 1st and 3rd Order Prediction
1400 PLT Set 1
1st and 3rd Order Prediction 1200
1000
800
600
400
200
0
0 200 400 600 800 1000 1200 1400
Mean Values

Mean vs. 1st Order Prediction Mean vs. 3rd Order Prediction Identity

4.4 Conclusions
Linearity evaluation of the instrument evaluated (SN: 000004) of all four parameters (WBC, RBC, HGB, and
2
PLT) were within the bounds of the repeatability, maximum nonlinearity, and r specification. Specifically,
all 8 individual linearity runs:
• Had no statistically significant higher-order coefficients or if they did, all observed non-linearities
were lower than the maximum non-linearity criteria appropriate for the parameter,
2
• Had coefficients of correlation (r ) that were higher than the minimum coefficient of correlation
criteria.
All linearity runs met their respective specifications, therefore the overall linearity evaluation was
considered passing.

5 Carryover

5.1 Evaluation Description

The primary measured parameters (WBC, RBC, HGB and PLT) were selected for evaluation of carryover on
three HumaCount 80TS Hematology Analyzers.
For each parameter, a high and low concentration sample was selected or prepared. The high
concentration sample was run in triplicate followed by the low concentration sample in triplicate. This
sequence was repeated four more times for a total of five times.
From the high and low runs, a high-to-low carryover figure of merit was computed and compared to
maximum carryover criteria for the parameter. If the calculated carryover was less than the maximum
carryover, the parameter was considered passing.
If all carryover sequences for all four parameters on all three instruments were considered passing, then
the overall carryover evaluation was considered passing.
Instruments 000004, 000005 and 00001T were selected for this carryover evaluation.

5.2 Data Description

Whole human blood with appropriate high and low concentrations were selected for carryover
evaluation. The concentrations were selected to be close to the extremes of the reportable range of the
parameter.
The following table shows the desired, actual, and reportable ranges of the high and low concentration
samples selected for carryover evaluation.

Design Verification and Product Data for HumaCount 80TS 11/28

Rev. 001
 Desired Range Actual Range Reportable Range
Parameter
Low High Low High Low High
3
WBC (10 /µL) 0.0 – 1.0 65.0 – 75.0 0.6 - 0.84 63.59 - 74 0 75
6
RBC (10 /µL) 0.0 – 1.0 7.0 – 8.0 0.42 - 0.49 7.68 – 8.17 0 8
HGB (g/dl) 1.0 – 3.0 20.0 – 25.0 1.2 - 1.3 20.5 – 21.6 1 25
3
PLT (10 /µL) 0 - 50 800 - 1000 26 - 69 743 - 1081 0 1000

5.3 Results
WBC Carryover
Carryover Test Overall Pass/Fail Pass
Parameter WBC Individual Test Carryover P/F
Instrument 1 000004 000004 0.04% Pass
Instrument 2 000005 000005 0.10% Pass
Instrument 3 00001T 00001T 0.03% Pass
Criteria 1.00%
High Sample ID WBC H
Low Sample ID WBC L

RBC Carryover
Carryover Test Overall Pass/Fail Pass
Parameter RBC Individual Test Carryover P/F
Instrument 1 000004 000004 0.03% Pass
Instrument 2 000005 000005 0.05% Pass
Instrument 3 00001T 00001T -0.03% Pass
Criteria 1.00%
High Sample ID RBC_H
Low Sample ID RBC_L

HGB Carryover
Carryover Test Overall Pass/Fail Pass
Parameter HGB Individual Test Carryover P/F
Instrument 1 000004 000004 0.20% Pass
Instrument 2 000005 000005 0.40% Pass
Instrument 3 00001T 00001T 0.10% Pass
Criteria 1.00%
High Sample ID RBC_H
Low Sample ID RBC_L

PLT Carryover
Carryover Test Overall Pass/Fail Pass
Parameter PLT Individual Test Carryover P/F
Instrument 1 000004 000004 0.12% Pass
Instrument 2 000005 000005 -0.03% Pass
Instrument 3 00001T 00001T 0.53% Pass
Criteria 1.00%
High Sample ID PLT H
Low Sample ID PLT L

Design Verification and Product Data for HumaCount 80TS 12/28

Rev. 001
 5.4 Conclusion
The carryover measurements for WBC, RBC, HGB and PLT were less than their respective criteria of 1.00%.
The overall carryover evaluation was therefore considered passing.

6. Long Term Precision

6.1 Evaluation Description

The primary measured parameters (WBC, RBC, HGB, and PLT) and derived parameters (GRA%, LYM%,
MID%, MCV, RDW, MPV) were selected for evaluation of long term precision.
Two replicates of low, normal, and high control samples were run in morning and two replicates were run
in the afternoon on the instruments This procedure was continued over 12 working days, until the last
Friday before the control material’s expiration date.
For each parameter and for each level of control tested, the estimated repeatability variance and the
estimated within-device precision, or reproducibility variance of the parameter at the given level were
calculated. A chi-square statistic was derived from each variance by multiplying it by the appropriate
degrees of freedom and by dividing it by the appropriate claim variance (derived from repeatability and
reproducibility acceptance criteria). Each chi-square statistic was compared to a corresponding critical chi-
square value. If both the repeatability and the within-device precision chi-square statistic were less than
their corresponding critical chi-square value, the parameter was considered passing at the appropriate
level.
The overall long-term precision evaluation was considered passing if all applicable parameters at all three
control levels pass for both instruments.
Instrument 000004 was selected for this long-term precision evaluation.

6.2 Data Description

Low, medium and high control materials from a single lot number were used for this evaluation. Control
materials were used because natural human whole blood samples were not stable over the long term
evaluation period.
The control material used in this evaluation was Diatron Diacon3 Hematology Controls, lot number B081.

6.3 Results
The following acceptance criteria were used to derive the appropriate chi-square statistic for evaluation of
repeatability and within-device precision:

WBC GRA% LYM% MID% RBC HGB MCV RDWcv PLT MPV
Parameter
103/µl % % % 106/µl g/dl fl % 103/µl fl
Repeatability SD Criteria 0.18 3.50 3.10 2.00 0.11 2.0 1.00 0.40 23.00 0.45
Repeatability CV Criteria 2.70% 1.70% 2.00% 1.70% 2.50% 6.00% 8.70%
Reproducibility SD Criteria 0.20 3.50 3.10 2.00 0.13 2.2 1.20 0.45 27.00 0.50
10.00
Reproducibility CV Criteria
3.40% 2.00% 2.40% 2.00% 3.00% 7.00% %

The following tables show the calculated mean, standard deviation, coefficient of variation, SD and
variance goals, calculated user SD and variance, degrees of freedom, chi-square statistics, critical chi-
square, and the accepted/rejected status of the claim. There were twelve total tables: one table for
repeatability and one for within-device precision for the instrument and three levels of controls
Long term repeatability low control

Design Verification and Product Data for HumaCount 80TS 13/28

Rev. 001
 Sam Parameter WBC GRA% LYM% MID% RBC HGB MCV RDWcv PLT MPV
ple (103/µl) (%) (%) (%) (106/µl) (g/dl) (fl) (%) (103/µl) (fl)
Type
Low Overall Mean 1.84 29.90 59.62 10.48 2.47 62.80 82.86 17.85 65.73 7.27
Contr Overall SD 0.10 1.98 1.82 1.05 0.05 1.19 0.49 0.29 7.34 0.53
ol
Overall CV% 5.27% 6.64% 3.06% 10.1% 1.83% 1.89% 0.60% 1.65% 11.2% 7.30%
Repeatability SD 0.18 3.50 3.10 2.00 0.11 2.00 1.00 0.40 23.00 0.45
Goal
Repeatability 0.03 12.25 9.61 4.00 0.01 4.00 1.99 0.20 529.0 0.40
Variance Goal
User SD 0.08 1.71 1.69 0.98 0.03 0.44 0.34 0.29 4.44 0.42
User Variance 0.01 2.92 2.85 0.95 0.00 0.19 0.12 0.08 19.70 0.18
Degrees of Freedom 24.00 24.00 24.00 24.00 24.00 24.00 24.00 24.00 24.00 24.00
Repeatabity Chi- 4.75 5.73 7.11 5.72 2.04 1.16 1.41 9.85 0.89 10.72
Square Stat
Critical Chi-Square 36.42 36.42 36.42 36.42 36.42 36.42 36.42 36.42 36.42 36.42
Claim Accept Accept Accept Accept Accept Accept Accept Accept Accept Accept
ed ed ed ed ed ed ed ed ed ed

Long term within-device precision low control

Sam Parameter WBC GRA% LYM% MID% RBC HGB MCV RDWcv PLT MPV
ple (103/µl) (%) (%) (%) (106/µl) (g/dl) (fl) (%) (103/µl) (fl)
Type
Low Overall Mean 1.84 29.90 59.62 10.48 2.47 62.80 82.86 17.85 65.73 7.27
Cont Overall SD 0.10 1.98 1.82 1.05 0.05 1.19 0.49 0.29 7.34 0.53
rol Overall CV% 5.27% 6.64% 3.06% 10.1% 1.83% 1.89% 0.60% 1.65% 11.2% 7.30%
Within-Device Precision 0.20 3.50 3.10 2.00 0.13 2.20 1.66 0.54 27.00 0.73
SD Goal
Within-Device Precision 0.04 12.25 9.61 4.00 0.02 4.84 2.76 0.29 729.0 0.53
Variance Goal
User SD 0.10 2.00 1.84 1.06 0.05 1.21 0.50 0.29 7.48 0.53
User Variance 0.01 4.01 3.39 1.12 0.00 1.46 0.25 0.09 56.01 0.28
Degrees of Freedom 42.00 37.00 35.00 44.00 35.00 21.00 28.00 45.00 21.00 38.00
Within-Device Precision 9.89 12.11 12.35 12.32 4.30 6.33 2.56 13.42 1.61 20.06
Chi-Square Stat
Critical Chi-Square 58.12 52.19 49.80 60.48 49.80 32.67 41.34 61.66 32.67 53.38
Claim Accepte Accep Accep Accep Accepte Accep Accep Accep Accept Accep
d ted ted ted d ted ted ted ed ted

Design Verification and Product Data for HumaCount 80TS 14/28

Rev. 001
Long term repeatability normal control
Sam Parameter WBC GRA% LYM% MID% RBC HGB MCV RDWcv PLT MPV
ple (103/µl) (%) (%) (%) (106/µl) (g/dl) (fl) (%) (103/µl) (fl)
Type
Nor Overall Mean 6.96 62.96 31.50 5.54 4.93 138.59 94.09 16.52 227.27 7.27
mal Overall SD 0.16 1.02 1.52 1.05 0.07 1.78 0.48 0.22 9.39 0.27
Contr
Overall CV% 2.36% 1.62% 4.82% 18.9% 1.36% 1.29% 0.51% 1.31% 4.13% 3.72%
ol
Repeatability SD Goal 0.18 3.50 3.10 2.00 0.11 2.00 1.00 0.40 23.00 0.45
Repeatability 0.04 12.25 9.61 4.00 0.01 7.67 2.56 0.17 529.00 0.40
Variance Goal
User SD 0.10 0.89 1.40 0.96 0.06 0.80 0.36 0.18 8.00 0.22
User Variance 0.01 0.78 1.97 0.92 0.00 0.65 0.13 0.03 64.05 0.05
Degrees of Freedom 24.00 24.00 24.00 24.00 24.00 24.00 24.00 24.00 24.00 24.00
Repeatability Chi- 7.24 1.54 4.91 5.51 6.88 2.02 1.20 4.47 2.91 2.89
Square Stat
Critical Chi-Square 36.42 36.42 36.42 36.42 36.42 36.42 36.42 36.42 36.42 36.42
Claim Accept Accept Accept Accept Accept Accept Accept Accept Accept Accept
ed ed ed ed ed ed ed ed ed ed

Long term within-device precision normal control

Sam Parameter WBC GRA% LYM% MID% RBC HGB MCV RDWcv PLT MPV
ple (103/µl) (%) (%) (%) (106/µl) (g/dl) (fl) (%) (103/µl) (fl)
Type
Nor Overall Mean 6.96 62.96 31.50 5.54 4.93 138.6 94.09 16.52 227.3 7.27
mal Overall SD 0.16 1.02 1.52 1.05 0.07 1.78 0.48 0.22 9.39 0.27
Cont
Overall CV% 2.36% 1.62% 4.82% 18.9 1.36% 1.29% 0.51% 1.31% 4.13% 3.72%
rol
%
Within-Device 0.24 3.50 3.10 2.00 0.13 3.33 1.88 0.50 27.00 0.73
Precision SD Goal
Within-Device 0.06 12.25 9.61 4.00 0.02 11.09 3.53 0.25 729.00 0.53
Precision Variance Goal
User SD 0.17 1.02 1.52 1.05 0.07 1.82 0.48 0.22 9.41 0.27
User Variance 0.03 1.04 2.30 1.10 0.00 3.30 0.23 0.05 88.52 0.07
Degrees of Freedom 26.00 43.00 44.00 44.00 41.00 23.00 34.00 41.00 43.00 41.00
Within-Device 12.53 3.66 10.52 12.11 11.00 6.83 2.25 7.81 5.22 5.64
Precision Chi-Square
Stat
Critical Chi-Square 38.89 59.30 60.48 60.48 56.94 35.17 48.60 56.94 59.30 56.94
Claim Accept Accept Accep Acce Accept Accept Accep Accep Accepte Accep
ed ed ted pted ed ed ted ted d ted

Design Verification and Product Data for HumaCount 80TS 15/28

Rev. 001
 Long term repeatability high control
Sam Parameter WBC GRA% LYM% MID% RBC HGB MCV RDWcv PLT MPV
ple (103/µl) (%) (%) (%) (106/µl) (g/dl) (fl) (%) (103/µl) (fl)
Type
High Overall Mean 18.48 82.97 12.38 4.65 6.03 183.4 104.1 15.76 454.3 7.58
Contr Overall SD 0.41 0.48 0.32 0.26 0.10 2.33 0.42 0.23 11.57 0.25
ol
Overall CV% 2.20% 0.57% 2.57% 5.51% 1.73% 1.27% 0.40% 1.47% 2.55% 3.26%
Repeatability SD 0.18 3.50 3.10 2.00 0.11 2.00 1.00 0.40 23.00 0.45
Goal
Repeatability 0.25 12.25 9.61 4.00 0.01 13.47 3.13 0.16 743.11 0.44
Variance Goal
User SD 0.19 0.42 0.29 0.21 0.10 1.42 0.28 0.19 9.75 0.22
User Variance 0.04 0.17 0.08 0.05 0.01 2.02 0.08 0.04 95.06 0.05
Degrees of Freedom 24.00 24.00 24.00 24.00 24.00 24.00 24.00 24.00 24.00 24.00
Repeatabity Chi- 3.60 0.34 0.21 0.27 18.32 3.59 0.62 5.65 3.07 2.62
Square Stat
Critical Chi-Square 36.42 36.42 36.42 36.42 36.42 36.42 36.42 36.42 36.42 36.42
Claim Accept Accept Accept Accept Accept Accept Accept Accept Accept Accept
ed ed ed ed ed ed ed ed ed ed

Long term within-device precision high control

Sam Parameter WBC GRA% LYM% MID% RBC HGB MCV RDWcv PLT MPV
ple (103/µl) (%) (%) (%) (106/µl) (g/dl) (fl) (%) (103/µl) (fl)
Type
High Overall Mean 18.48 82.97 12.38 4.65 6.03 183.4 104.1 15.76 454.3 7.58
Cont Overall SD 0.41 0.48 0.32 0.26 0.10 2.33 0.42 0.23 11.57 0.25
rol
Overall CV% 2.20% 0.57% 2.57% 5.51% 1.73% 1.27% 0.40% 1.47% 2.55% 3.26%
Within-Device Precision 0.63 3.50 3.10 2.00 0.13 4.40 2.08 0.47 31.80 0.76
SD Goal
Within-Device Precision 0.40 12.25 9.61 4.00 0.02 19.36 4.33 0.22 1011.2 0.58
Variance Goal 4
User SD 0.41 0.48 0.32 0.26 0.10 2.37 0.42 0.23 11.65 0.25
User Variance 0.17 0.23 0.10 0.07 0.01 5.62 0.18 0.05 135.7 0.06
Degrees of Freedom 23.00 44.00 43.00 39.00 42.00 25.00 25.00 41.00 39.00 44.00
Within-Device Precision 9.87 0.81 0.45 0.65 27.26 7.26 1.04 10.13 5.24 4.67
Chi-Square Stat
Critical Chi-Square 35.17 60.48 59.30 54.57 58.12 37.65 37.65 56.94 54.57 60.48
Claim Accepte Accep Accep Accep Accepte Accep Accep Accep Accept Accep
d ted ted ted d ted ted ted ed ted

6.4 Conclusions
The null hypothesis that the appropriate observed CV% and SD was less than the claim CV% or at least
less than claimed SD, was accepted for all parameters at all three control levels for the instrument for
booth repeatability and within-device precision. Therefore, the overall evaluation of long-term precision
was considered to pass.

7 Method Comparison of HumaCount 80TS Hematology Analyzer vs. Cell-Dyn 3700

7.1 Evaluation Description

The accuracy evaluation of the HumaCount 80TS instrument was conducted at HUMAN reference
laboratories.

Design Verification and Product Data for HumaCount 80TS 16/28

Rev. 001
The comparator instrument selected for this evaluation was the Abbott Cell-Dyn 3700 analyzer. The
evaluation protocol calls for a minimum of 80 samples to be collected at each site for a total of 160
samples. A specific distribution of samples parameters were required in the following ranges

Parameter Range A Range B Range C Range D Range E Total

3
WBC 10 /µl 0.00 - 2.00 2.01 - 5.00 5.01 - 11.00 11.01-25.00 25.01 - 75.00
10% (8) 20% (16) 40% (32) 20% (16) 10% (8) 100% (80)
6
RBC 10 /µl 0.00 - 3.00 3.01 - 4.00 4.01 - 6.00 6.01 -8.00 -
10% (8) 30% (24) 50% (40) 10% (8) - 100% (80)
HGB g/dl 2.00 – 9.00 9.01 – 12.00 12.01 – 17.00 - 17.01 – 25.00
15% (12) 25% (20) 50% (40) - 10% (8) 100% (80)
3
PLT 10 /µl 0-50.00 50.01 – 151.01 – 301.01 – 450.01 –
150.00 300.00 450.00 1000.00
10% (8) 20% (16) 30% (24) 30% (24) 10% (8) 100% (80)

The parameters selected for the evaluation of accuracy were the primary measured parameters (WBC,
RBC, HGB and PLT) and the derived parameters (LYM%, MID%, GRA%, MCV, RDWcv and MPV). Calculated
parameters that were simple functions of primary and derived parameters were not selected for
evaluation.
The reference instrument was a 5-part instrument, and the test analyzer was a 3-part instrument. There
was a mapping between the 5-part and the 3-part results: all granulocyte forms (neutrophil (NEU%),
eosinophil (EOS%) and basophil (BAS%)) sum up to correspond to the GRA% results of the HumaCount
80TS. The LYM% results on the CD3700 map to the LYM% results on the HumaCount 80TS, and the MON%
results of the CD3700 map to the MID% results of the HumaCount 80TS.
The combined data from all two sites were evaluated for outliers and analyzed using difference analysis.
Deming regression was used in the analysis of difference. The difference was calculated at two or three
clinical decision points as appropriate to the parameter, and at two range points representing typical
values of the parameter.
The term “bias” was used to describe the difference between a test method and a reference method. This
evaluation compares a test instrument against a comparator instrument and not against a reference
method, so the term “predictive bias” will be used rather than “bias.” The statistical approach to
calculation was identical in either case.
Although two replicates for both the test and comparator instruments were collected for each sample,
only the first sample was used in the calculation of predictive bias.
The absolute value of the calculated predictive bias at each decision point was compared to a maximum
goal calculated from the absolute and percent predictive bias criteria. If the predictive bias was less than
the corresponding goal, the predictive bias at the point was considered to meet its acceptance criteria. If
the predictive bias at all clinical decision points and range points for all parameters meet their acceptance
criteria, the overall evaluation was considered to pass successfully.
For each parameter, the following items were provided:
A table showing the criteria, clinical decision points and range points, the bias goal, the calculated
predictive bias with and without outliers removed and the pass/fail status with and without
outliers
A table showing the N number, slope and intercept, and confidence interval around the slope and
intercept with and without outliers
A scatter plot with Deming fit with the identity, allowable difference and 95% confidence interval
lines without outliers

Analyse-It for Microsoft Excel version 2.4 was used as a method evaluation tool to calculate predictive
bias using Deming regression for each parameter.

Design Verification and Product Data for HumaCount 80TS 17/28

Rev. 001
The following table describes the absolute and percent predictive bias criteria for each parameter under
evaluation, and the clinical decision points and range points at which predictive bias was calculated and
evaluated against the acceptance criteria.

Parameter Predictive Bias Evaluation Levels

Criteria
Absolute Percent Clinical Clinical Clinical Decision Range Range
Decision Point Decision Point Point 3 Low High
1 2
3
WBC (10 /µl) 0.30 6.00% 2.00 4.20 10.50 0.00 75.00
GRA% (%) 3.00 10.00% 10.00 40.00 86.00 0.00 100.00
LYM% (%) 3.00 10.00% 20.00 45.00 80.00 0.00 100.00
MID% (%) 3.00 10.00% 2.00 17.00 0.00 40.00
6
RBC (10 /µl) 0.15 6.00% 3.84 5.85 0.00 8.00
HGB (g/dl) 0.30 6.00% 6.00 11.70 17.20 1.00 25.00
MCV (fl) 1.00 6.00% 79.10 98.60 50.00 120.00
RDWcv (%) 1.00 6.00% 11.80 15.10 8.00 20.00
3
PLT (10 /µl) 15.00 8.00% 50.00 134.00 429.00 0.00 1000.0
0
MPV (fl) 1.00 10.00% 7.10 10.80 5.00 30.00

7.2 Data Description

7.2.1 CLSI EP9-2A Outlier Evaluation

The following table describes the number of samples collected at each site, and the number of outliers
determined using the procedure described in CLSI EP9-2A.

Data Site Samples Collected Outliers Removed Percentage of Outliers Total Samples Analyzed
Margaret 172 0 0.00% 172
Honved 144 3 2.08% 141
Total 316 3 0.95% 313

A total of 316 samples were collected form the two sites in this evaluation. From these, 3 between-
method outliers were removed using the method described in CLSI EP9-2A section 4.4. The total
percentage of outliers removed was 0.95%, well under the 2.5% (1 sample in 40) described by CLSI EP9-A2.
Only the first replicate of the test and comparator instruments were used, so no within-method replicate
outliers were removed. The remaining 313 samples were described in the following data descriptions.

7.3 Results

7.3.1 WBC Predictive Bias Analysis

Par. Crite Clin. Bias Without Outliers Including Outliers
ria Dec. Goal Pr. Bias 95% CI P/F Pr. Bias 95% CI P/F
Point
WBC 0.30 2 0.3 -0.0212 -0.2389 to 0.1966 Pass -0.0765 -0.3236 to 0.1706 Pass
3
(10 / or 4.2 0.3 -0.0218 -0.1517 to 0.1081 Pass -0.0434 -0.1827 to 0.0959 Pass
µl) 6% 10.5 0.63 -0.0236 -0.1721 to 0.1249 Pass 0.0513 -0.1583 to 0.2610 Pass
Range Bias Pr. Bias 95% CI Pr. Bias Pr. Bias 95%
Point Goal CI
0 0.3 -0.0206 -0.3200 to 0.2789 Pass -0.1066 -0.4552 to 0.2402 Pass
75 4.5 -0.0420 -2.8654 to 2.7815 Pass 1.0213 -2.5230 to 4.5657 Pass

Design Verification and Product Data for HumaCount 80TS 18/28

Rev. 001
 Parameter Outliers N Item Value 95% Confidence Interval
WBC Without Outliers 313 Intercept -0.02 -0.32 to 0.28
3
(10 /µl) Slope 1.00 0.96 to 1.04
Including Outliers 316 Intercept -0.11 -0.46 to 0.24
Slope 1.02 0.96 to 1.07

WBC Method Comparison Scatter Plot without Outliers

Scatter Plot with Deming Fit

80

70

60
WBC - HC 80TS

50
Identity

40 Allowable bias (0.3 or

6%)
30 Deming fit
(-0.02 + 1.00x)

20 95% CI bands

10

0
0 20 40 60 80
WBC - CD3700

7.3.2 GRA% Predictive Bias Analysis

Par. Criteria Clin. Bias Goal Without Outliers Including Outliers
Dec. Pr. 95% CI P/F Pr. 95% CI P/F
Point Bias Bias
GRA% 3.00 or 10 3 2.0356 -0.4479 to 4.5191 Pass 3.8089 0.0725 to 7.5453 Fail
(%) 10% 40 4 1.8221 0.5713 to 3.0728 Pass 2.7756 0.8228 to 4.7283 Pass
86 8.6 1.4946 0.4943 to 2.4949 Pass 1.1912 0.0834 to 2.2991 Pass
Range Bias Goal Pr. 95% CI P/F Pr. 95% CI P/F
Point Bias Bias
0 3 2.1068 -0.7993 to 5.0129 Pass 4.1533 -0.1858 to 8.4924 Fail
100 10 1.3949 -0.1510 to 2.9408 Pass 0.7090 -1.1771 to 2.5952 Pass

Parameter Outliers N Item Value 95% Confidence Interval

GRA% Without Outliers 313 Intercept 2.11 -0.80 to 5.01
(%) Slope 0.99 0.95 to 1.04
Including 316 Intercept 4.15 -0.19 to 8.49
Outliers Slope 0.97 0.90 to 1.03

Design Verification and Product Data for HumaCount 80TS 19/28

Rev. 001
GRA% Method Comparison Scatter Plot without Outliers

Scatter Plot with Deming Fit

100

90

80

70
GRA% - HC 80TS

60 Identity

50 Allowable bias (3 or
10%)
40
Deming fit
(2.11 + 0.99x)
30
95% CI bands
20

10

0
0 20 40 60 80 100
NEU%+EO%+BAS% - CD3700

7.3.3 LYM% Predictive Bias Analysis

Par. Criteria Clin. Bias Goal Without Outliers Including Outliers
Dec. Pr. Bias 95% CI P/F Pr. Bias 95% CI P/F
Point
LYM% 3.00 or 20 3 -0.6710 -1.0318 to -0.3102 Pass -0.7700 -1.1516 to -0.3885 Pass
(%) 10% 45 4.5 -1.6472 -2.3906 to -0.9038 Pass -1.9923 -3.1359 to -0.8486 Pass
80 8 -3.0139 -4.8069 to -1.2209 Pass -3.7034 -6.3455 to -1.0614 Pass
Range Bias Goal Pr. Bias 95% CI P/F Pr. Bias 95% CI P/F
Point
0 3 0.1100 -0.7144 to 0.9343 Pass 0.2077 -0.7666 to 1.1821 Pass
100 10 -3.7949 -6.2075 to -1.3822 Pass -4.6812 -8.1942 to -1.1683 Pass

Parameter Outliers N Item Value 95% Confidence Interval

LYM% Without Outliers 313 Intercept 0.11 -0.71 to 0.93
(%) Slope 0.96 0.93 to 0.99
Including 316 Intercept 0.21 -0.77 to 1.18
Outliers Slope 0.95 0.91 to 0.99

Design Verification and Product Data for HumaCount 80TS 20/28

Rev. 001
LYM% Method Comparison Scatter Plot without Outliers

Scatter Plot with Deming Fit

100

90

80

70
LYM% - HC 80TS

60 Identity

50 Allowable bias (3 or
10%)
40
Deming fit
(0.11 + 0.96x)
30
95% CI bands
20

10

0
0 20 40 60 80 100
LYM% - CD3700

7.3.4 MID% Predictive Bias Analysis

Par. Criteria Clin. Bias Without Outliers Including Outliers
Dec. goal Pr. Bias 95% CI P/F Pr. Bias 95% CI P/F
Point
MID% 3.00 or 2 3 -0.685 -3.5227 to 2.1522 Pass 0.409 -2.3663 to 3.1839 Pass
(%) 10% 17 3 -0.711 -6.2304 to 4.8083 Pass -2.747 -8.0881 to 2.5938 Pass
Range Bias Pr. Bias 95% CI P/F Pr. Bias 95% CI P/F
Point Goal
0 3 -0.682 -4.6190 to 3.2554 Pass 0.8296 -3.0144 to 4.6736 Pass
40 4 -0.750 -19.0035 to 17.5021 Pass -7.5863 -25.2981 to 10.1254 Fail

Parameter Outliers N Item Value 95% Confidence Interval

MID% Without Outliers 313 Intercept -0.68 -4.62 to 3.26
(%) Slope 1.00 0.44 to 1.55
Including 316 Intercept 0.83 -3.01 to 4.67
Outliers Slope 0.79 0.25 to 1.33

Design Verification and Product Data for HumaCount 80TS 21/28

Rev. 001
MID% Method Comparison Scatter Plot without Outliers

Scatter Plot with Deming Fit

50

45

40

35
MID% - HC 80TS

30 Identity

25 Allowable bias (3 or
10%)
20
Deming fit
(-0.68 + 1.00x)
15
95% CI bands
10

0
0 10 20 30 40 50
MON% - CD3700

7.3.5 RBC Predictive Bias Analysis

Par. Criteria Clin. Bias goal Without Outliers Including Outliers
Dec. Pr. Bias 95% CI P/F Pr. Bias 95% CI P/F
Point
RBC 0.15 or 3.84 0.23 -0.036 -0.0465 to -0.0259 Pass -0.037 -0.0476 to -0.0268 Pass
(106/µl) 6% 5.85 0.315 -0.005 -0.0299 to 0.0193 Pass -0.006 -0.0302 to 0.0187 Pass
Range Bias Goal Pr. Bias 95% CI P/F Pr. Bias 95% CI P/F
Point
0 0.15 -0.095 -0.1449 to -0.0453 Pass -0.097 -0.1470 to -0.0475 Pass
8 0.48 0.028 -0.0219 to 0.0773 Pass 0.028 -0.0214 to 0.0772 Pass

Parameter Outliers N Item Value 95% Confidence Interval

RBC Without Outliers 313 Intercept -0.10 -0.14 to -0.05
6
(10 /µl) Slope 1.02 1.00 to 1.03
Including 316 Intercept -0.10 -0.15 to -0.05
Outliers Slope 1.02 1.00 to 1.03

Design Verification and Product Data for HumaCount 80TS 22/28

Rev. 001
RBC Method Comparison Scatter Plot without Outliers

Scatter Plot with Deming Fit

8

6
RBC - HC 80TS

Identity
5

Allowable bias (0.15 or

4 6%)

Deming fit
(-0.10 + 1.02x)
3
95% CI bands

1
1 3 5 7
RBC - CD3700

7.3.6 HGB Predictive Bias Analysis

A HGB nonlinearity found during linearity analysis as mentioned in section 4.4. The HGB values of
accuracy measurements were recalculated with appropriate equation, implemented in SW v0.93, offline
and the results were recalculated with those values thus the following analysis based on the corrected
values.

Par. Criteria Clin. Dec. Point Bias goal Without Outliers Including Outliers
Pr. Bias 95% CI P/F Pr. Bias 95% CI P/F
HGB 3.0 or 6% 60 3.6 0.3 -0.4 to 0.9 Pass 0.3 -0.4 to 0.9 Pass
(g/l) 117 7.0 0.0 -0.3 to 0.3 Pass 0.0 -0.3 to 0.3 Pass
172 10.3 -0.2 -0.7 to 0.2 Pass -0.2 -0.7 to 0.2 Pass
Range Point Bias Goal Pr. Bias 95% CI P/F Pr. Bias 95% CI P/F
10 3 0.5 -0.6 to 1.6 Pass 0.5 -0.6 to 1.6 Pass
250 15 -0.5 -1.6 to 0.5 Pass -0.6 -1.6 to 0.5 Pass

Parameter Outliers N Item Value 95% Confidence Interval

HGB Without Outliers 313 Intercept 0.54 -0.63 to 1.71
(g/l) Slope 1.00 0.99 to 1.00
Including 316 Intercept 0.53 -0.63 to 1.69
Outliers Slope 1.00 0.99 to 1.00

Design Verification and Product Data for HumaCount 80TS 23/28

Rev. 001
HGB Method Comparison Scatter Plot without Outliers

Scatter Plot with Deming Fit

220

200

180
HGB - HC 80TS HGB corr

160

140 Identity

120 Allowable bias (3 or

6%)
100
Deming fit
(0.54 + 1.00x)
80
95% CI bands
60

40

20
20 70 120 170 220
HGB - CD3700

7.3.7 MCV Predictive Bias Analysis

Par. Criteria Clin. Bias Without Outliers Including Outliers
Dec. goal Pr. Bias 95% CI P/F Pr. Bias 95% CI P/F
Point
MCV 1.00 or 79.1 4.746 -0.7305 -0.9992 to -0.4619 Pass -0.7351 -1.0031 to -0.4670 Pass
(fl) 6% 98.6 5.916 0.7268 0.4578 to 0.9957 Pass 0.7298 0.4611 to 0.9985 Pass
Range Bias Pr. Bias 95% CI P/F Pr. Bias 95% CI P/F
Point Goal
50 3 -2.9053 -3.8447 to -1.9659 Pass -2.8911 -3.8607 to -1.9816 Pass
120 7.2 2.3261 1.5684 to 3.0838 Pass 2.3375 1.5794 to 3.0956 Pass

Parameter Outliers N Item Value 95% Confidence Interval

MCV Without Outliers 313 Intercept -6.64 -8.77 to -4.51
(fl) Slope 1.07 1.05 to 1.10
Including 316 Intercept -6.68 -8.81 to -4.55
Outliers Slope 1.08 1.05 to 1.10

Design Verification and Product Data for HumaCount 80TS 24/28

Rev. 001
MCV Method Comparison Scatter Plot without Outliers

Scatter Plot with Deming Fit

120

110

100
MCV - HC 80TS

Identity
90

Allowable bias (1 or
80 6%)

Deming fit
(-6.64 + 1.07x)
70
95% CI bands

60

50
50 60 70 80 90 100 110 120
MCV - CD3700

7.3.8 RDWcv Predictive Bias Analysis

Par. Criteria Clin. Dec. Bias Without Outliers Including Outliers
Point goal Pr. Bias 95% CI P/F Pr. Bias 95% CI P/F
RDWcv 0.50 or 11.8 1.0000 -0.055 -0.4200 to 0.3107 Pass -0.053 -0.4186 to 0.3131 Pass
(%) 6% 15.1 1.0000 -0.159 -0.2484 to -0.0698 Pass -0.161 -0.2489 to -0.0727 Pass
Range Bias Pr. Bias 95% CI P/F Pr. Bias 95% CI P/F
Point Goal
8 1 0.0657 -0.7365 to 0.8678 Pass 0.0717 -0.7297 to 0.8730 Pass
20 1.2 -0.314 -0.9190 to 0.2906 Pass -0.3213 -0.9224 to 0.2799 Pass

Parameter Outliers N Item Value 95% Confidence Interval

RDWcv Without Outliers 313 Intercept 0.32 -1.41 to 2.05
(%) Slope 0.97 0.85 to 1.08
Including 316 Intercept 0.33 -1.39 to 2.06
Outliers Slope 0.97 0.85 to 1.08

Design Verification and Product Data for HumaCount 80TS 25/28

Rev. 001
RDWCV Method Comparison Scatter Plot without Outliers

Scatter Plot with Deming Fit

32

30

28

26
RDWcv - HC 80TS

24 Identity

22 Allowable bias (1 or
6%)
20
Deming fit
(0.32 + 0.97x)
18
95% CI bands
16

14

12
12 17 22 27 32
RDW - CD3700

7.3.9 PLT Predictive Bias Analysis

Par. Criteria Clin. Bias goal Without Outliers Including Outliers
Dec. Pr. Bias 95% CI P/F Pr. Bias 95% CI P/F
Point
PLT 15 or 50 15 -6.3047 -11.7221 to -0.8872 Pass -6.1847 -11.5491 to -0.8202 Pass
(103/µl) 8% 134 15 -0.6918 -3.7671 to 2.3835 Pass -0.6341 -3.6796 to 2.4115 Pass
429 34.32 19.0202 11.4269 to 26.6135 Pass 18.8591 11.3249 to 26.3934 Pass
Range Bias Goal Pr. Bias 95% CI P/F Pr. Bias 95% CI P/F
Point
0 15 -9.6457 -16.5928 to -2.6985 Pass -9.4886 -16.3687 to -2.6085 Pass
1000 80 57.1745 31.2306 to 83.1184 Pass 60.2796 30.8679 to 82.3121 Pass

Parameter Outliers N Item Value 95% Confidence Interval

PLT Without Outliers 313 Intercept -9.65 -16.59 to -2.70
3
(10 /µl) Slope 1.07 1.03 to 1.10
Including 316 Intercept -9.49 -16.37 to -2.61
Outliers Slope 1.07 1.03 to 1.10

Design Verification and Product Data for HumaCount 80TS 26/28

Rev. 001
PLT Method Comparison Scatter Plot without Outliers

Scatter Plot with Deming Fit

900

800

700

600
PLT - HC 80TS

Identity
500
Allowable bias (15 or
400 8%)

Deming fit
300 (-9.65 + 1.07x)

95% CI bands
200

100

0
0 200 400 600 800
PLT - CD3700

7.3.10 MPV Predictive Bias Analysis

Par. Criteria Clin. Dec. Bias Without Outliers Including Outliers
Point Goal Pr. Bias 95% CI P/F Pr. Bias 95% CI P/F
MPV 0.50 or 7.1 1 0.1253 -0.1982 to 0.4488 Pass 0.1051 -0.2188 to 0.4290 Pass
(fl) 10% 10.8 1.08 -0.0089 -0.1862 to 0.1683 Pass -0.0190 -0.1958 to 0.1577 Pass
Range Bias Pr. Bias 95% CI P/F Pr. Bias 95% CI P/F
Point Goal
5 1 0.2015 -0.3529 to 0.7558 Pass 0.1755 -0.3796 to 0.7307 Pass
30 3 -0.7055 -3.0431 to 1.6321 Pass -0.6631 -3.0034 to 1.6773 Pass

Parameter Outliers N Item Value 95% Confidence Interval

MPV Without Outliers 644 Intercept 0.38 -0.74 to 1.50
(fl) Slope 0.96 0.85 to 1.08
Including 656 Intercept 0.34 -0.78 to 1.47
Outliers Slope 0.97 0.85 to 1.08

Design Verification and Product Data for HumaCount 80TS 27/28

Rev. 001
 MPV Method Comparison Scatter Plot without Outliers

Scatter Plot with Deming Fit

18

16

14
MPV - HC 80TS

Identity
12

Allowable bias (1 or
10 10%)
Deming fit
(0.38 + 0.96x)
8
95% CI bands

4
4 9 14
MPV - CD3700

7.4 Conclusions
The method comparison of the HumaCount 80TS against the Abbott Cell-Dyn 3700 analyzer (predicate
instrument) met the following evaluation requirements:
Two sites were used
A sufficient number of samples were collected at each site
A sufficient number of samples were collected in each range required by EP9-A2 ranges
The absolute value of the calculated predictive bias of all clinical decision points and range points
were below the predictive bias goals for the points determined from the acceptance criteria for all
parameters
Therefore, the method comparison evaluation was considered to meet its acceptance criteria and all the
requirements of the data collection and its evaluation.

8 Overall Conclusions
The following conclusions can be drawn from the evaluation summaries contained in this report:
Evaluation protocols were written for each evaluation that conform to applicable standards
Data collection for each evaluation in this report was conducted according to their respective
protocol and conforming to applicable standards
Statistical data analysis of the data for each evaluation was conducted in accordance with
applicable standards
All evaluations summarized in this report met their acceptance criteria

Design Verification and Product Data for HumaCount 80TS 28/28

Rev. 001