510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION

DECISION SUMMARY

A. 510(k) Number:

K180020

B. Purpose for Submission:

Clearance of a new device

C. Manufacturer and Instrument Name:

PixCell Medical Technologies, Ltd.; HemoScreen Hematology Analyzer

D. Type of Test or Tests Performed:

Quantitative complete blood count with 5-part leukocyte differential: RBC, WBC, PLT,
HGB, HCT, MCV, MCH, MCHC, RDW, MPV, NEUT#, NEUT%, MONO#, MONO%,
LYMP#, LYMP%, EO#, EO% and BASO#, BASO%.

E. System Descriptions:

1. Device Description:

The HemoScreen is a point-of-care (POC), automated hematology analyzer that provides

results for CBC parameters and a 5-part leukocyte differential, in capillary and venous
whole blood samples. The HemoScreen system is a tabletop device and is comprised of
the following components: HemoScreen reader (analyzer), software, cartridge preloaded
with reagents, sampler, on-board internal quality control, and external liquid quality
controls. The cartridge module comprises reagent compartments, a microfluidic chip and
a translucent measurement portion. The reagents in the cartridge enable visoelastic
focusing, lysis of red blood cells and white blood cell (WBC) staining. In addition to the
cartridge, the system includes a disposable sampler, which is used to collect the blood
sample and then transfer it to the cartridge.

2. Principles of Operation:
The HemoScreen analyzer includes several modules (optical, mechanical, and electrical
modules), a processor and controller that work together to measure blood samples that
have been prepared inside disposable cartridges. The blood sample is collected with an
additional disposable unit called a sampler. Once filled, the sampler is inserted into the
cartridge in a single action, whereupon the cartridge is inserted into the reader for
automatic sample preparation/staining and measurement. The cartridge is supplied
preloaded with all required reagents.

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 Once the cartridge is inserted into the reader, blood is expelled from the capillaries into
the reagent compartments. The reader then mixes the blood sample with the reagents by
alternately pressing compressible portions of the cartridge, eventually causing the
suspension of cells to flow into the microfluidic chamber. Cells flowing in the
microfluidic chamber focus into a single-cell plane due to viscoelastic focusing. The
reader then captures images of the focused cells and analyzes them in real time using
machine vision algorithms. The reader interfaces with the cartridge mechanically and
optically, and has no direct contact with the fluid inside the cartridge. When analysis is
complete, the results are displayed to the user on the reader's touch screen.
Leukocytes are classified based on their staining properties and morphology, whereas
absolute counts are obtained by counting the cells contained in a chamber of predetermined
volume. Test results are obtained within six minutes and the results are saved.

3. Modes of Operation:

Does the applicant’s device contain the ability to transmit data to a computer, webserver,
or mobile device?

Yes ____X___ or No ________

Does the applicant’s device transmit data to a computer, webserver, or mobile device
using wireless transmission?

Yes ________ or No ___X____

4. Specimen Identification:

Specimen identification is performed by manual keyboard entry or use of a barcode

reader.

5. Specimen Sampling and Handling:

HemoScreen can be used with either capillary or venous anticoagulated whole blood,
collected in K2EDTA. Capillary blood sampling is performed by routine fingertip
puncture using a standard lancet, and the blood is collected in an K2EDTA microtube.
Venous blood, thoroughly mixed and at room temperature, can be used as well.

6. Calibration:
Factory calibration. The calibration of HemoScreen is traceable to the reference methods
described in CLSI H26-A2.

7. Quality Control:
The HemoScreen system includes both on-board internal and external quality controls.
Internal quality control where the software verifies performance of the optics, reagent
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 mixing, and instrument pneumatics.
PIX-CBC Hematology Controls, 3-level commercial liquid quality controls will be used
to cover all HemoScreen parameters. PIX-CBC Hematology controls are produced by
R&D Systems, a Bio-Techne brand, Minneapolis, MN.

8. Software:

FDA has reviewed applicant’s Hazard Analysis and Software Development processes for
this line of product types:

Yes___X____ or No________

F. Regulatory Information:

1. Regulation section:

21 CFR 864.5220, Automated differential cell counter

2. Classification:

Class II

3 Product code:

GKZ – Counter, Differential Cell

4. Panel:

Hematology (81)

G. Intended Use:

1. Indication(s) for Use:

The HemoScreen is a point-of-care (POC) automated hematology analyzer intended for

the enumeration and classification of the following parameters in capillary and venous
whole blood (K2EDTA anticoagulated): WBC, RBC, HGB, HCT, MCV, MCH, MCHC,
RDW, PLT, MPV, NEUT%, NEUT#, LYMP%, LYMP#, MONO%, MONO#, EO%,
EO#, BASO%, and BASO#. The HemoScreen is for in vitro diagnostic use in clinical
laboratories and/or POC settings for adults and children at least 2 years of age.

2. Special Conditions for Use Statement(s):

For prescription use only

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H. Substantial Equivalence Information:

1. Predicate Device Name(s) and 510(k) numbers:

Sysmex® XN-Series (XN-10, XN-20) Automated Hematology Analyzer (Sysmex

Analyzer) – K112605

2. Comparison with Predicate Device:

Similarities
Item Device Predicate
HemoScreen Sysmex XN Series
Intended Use The HemoScreen is a point-of- The XN-Series modules (XN-10
care (POC) automated and XN-20) modules are
hematology analyzer intended quantitative multi-parameter
for the enumeration and automated hematology analyzers
classification of the following intended for in vitro diagnostic use
parameters in capillary and in screening patient populations
venous whole blood (K2EDTA found in clinical laboratories. The
anticoagulated): WBC, RBC, XN-Series modules classify and
HGB, HCT, MCV, MCH, enumerate the following
MCHC, RDW, PLT, MPV, parameters for whole blood: WBC,
NEUT%, NEUT#, LYMP%, RBC, HGB, HCT, MCV, MCH,
LYMP#, MONO%, MONO#, MCHC, PLT, NEUT%/#,
EO%, EO#, BASO%, and LYMPH%/#, MONO%/#, EO%/#,
BASO#. The HemoScreen is BASO%/#, IG%/#, RDW-CV,
for in vitro diagnostic use in RDW-SD, MPV, NRBC%/#,
clinical laboratories and/or RET%/#, IPF, IRF, RET-He and
POC settings for adults and has a Body Fluid mode for body
children at least 2 years of age. fluids. The Body Fluid mode
enumerates the WBC-BF, RBC-
BF, MN%/#, PMN%/# and TC-BF
parameters in cerebrospinal fluids
(CSF), serous fluids (peritoneal,
pleural) and synovial fluids.
Whole blood should be collected
in K2 or K3EDTA anticoagulant
and, Serous and Synovial fluids in
K2EDTA anticoagulant to prevent
clotting of fluid. The use of
anticoagulants with CSF
specimens is neither required nor
recommended.
Sample Type Venous and capillary Same
anticoagulated whole blood
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 Differences
Item Device Predicate
Parameters · Red Blood Cells (RBC), · Red Blood Cells (RBC),
Measured · White Blood Cells (WBC), · White Blood Cells (WBC),
· Platelets (PLT), · Platelets (PLT),
· Hemoglobin (HGB), · Hemoglobin (HGB),
· Hematocrit (HCT), · Hematocrit (HCT),
· Mean Corpuscular · Mean Corpuscular (erythrocyte)
(erythrocyte) Volume Volume (MCV),
(MCV), · Mean Cell (erythrocyte)
· Mean Cell (erythrocyte) Hemoglobin (MCH),
Hemoglobin (MCH), · Mean Cell (erythrocyte)
· Mean Cell (erythrocyte) Hemoglobin Concentration
Hemoglobin Concentration (MCHC),
(MCHC), · Red Blood Cell Distribution
· Red Blood Cell Distribution Width (RDW)-CV/SD
Width (RDW)-CV · Mean Platelets Volume (MPV),
· Mean Platelets Volume · Neutrophils (NEUT; #/%),
(MPV), · Monocytes (MONO; #/%),
· Neutrophils (NEUT; #/%), · Lymphocytes (LYMP; #/%),
· Monocytes (Mono: #/%) · Eosinophils (EO; #/%) and
· Lymphocytes (Lymp; #/%) · Basophils (BASO; #/%)
· Eosinophils (EO, #/%) · IG%/#,
· Basophils (Baso; #/%) · NRBC#/%,
· RET%/#,
· IPF, IRF,
· RET-He,
· WBC-BF, (Body fluids)
· RBC-BF, (Body fluids)
· MN%/#, (Body fluids)
· PMN%/#, (Body fluids)
· TC-BF (Body fluids)
Throughput 10 samples/hour 100 samples/hour maximum
depending on mode used
Test Principle The HemoScreen uses The XN Series performs analyses
viscoelastic focusing which using the following methods:
causes the cells to perfectly fluorescence flow cytometry and
align into a plane. High sheath flow DC detection. The
resolution microscopic images first is used to differentiate
are taken of the flowing cells. between WBC types and abnormal
Each image is analyzed using cells while the second is used for
machine vision algorithms and RBC and PLT analysis.

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 Differences
Item Device Predicate
the different cell types are The HGB is measured using a
differentiated and counted. standard photometric method on
WBCs are stained prior to the lysed RBC solution which is
analysis so as to enable reacted with SLS forming a
differentiation between their colored SLS-HGB complex.
subtypes and abnormal cells.
HGB is calculated based on
the optical density measured
on individual intact cells.
Calibration Factory calibrated Requires calibration by the
operator
Anticoagulant K2EDTA K2EDTA and K3DTA
Sample 40 μL 88 μL
Volume

I. Special Control/Guidance Document Referenced (if applicable):

CLSI EP05-A3, Evaluation of Precision of Quantitative Measurement Procedures; Approved

Guideline – Third Edition

CLSI H20-A2, Reference Leukocyte (WBC) Differential Count (Proportional) and

Evaluation of Instrumental Methods; Approved Standard – Second Edition

CLSI H26-A2, Validation, Verification, and Quality Assurance of Automated Hematology

Analyzers; Approved Standard – Second Edition

CLSI EP06-A, Evaluation of the Linearity of Quantitative Measurement Procedures: A

Statistical Approach; Approved Guideline

CLSI EP07-A2, Interference Testing In Clinical Chemistry; Approved Guideline -Second

Edition

CLSI EP17-A2, Evaluation of Detection Capability for Clinical Laboratory Measurement

Procedures; Approved Guideline – Second Edition

CLSI EP28-A3c, Defining, Establishing, and Verifying Reference Intervals in the Clinical
Laboratory; Approved Guideline – Third Edition

J. Performance Characteristics:

1. Analytical Performance:
a. Accuracy:

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Method comparison studies were performed at three point-of-care (POC) sites (2 sites
in the U.S. and one site in Israel) with 495 residual venous blood specimens collected
in standard K2EDTA tubes. The studies included normal and pathological samples to
assess the HemoScreen performance across the analytical measurement ranges
(AMRs) as well as at medical decision points. The pathological samples included
conditions: acute inflammation, bacterial and viral infections, aplastic anemia, acute
and chronic leukemias (lymphocytic or myelocytic), multiple myeloma (plasma cell
leukemia), microcytic anemia, normocytic anemia, macrocytic anemia,
hemoglobinopathies, thalassemia, iron and folate deficiencies. The samples were
represented by an age range of 4–92 years old, and the study population included 277
males (56%) and 218 females (44%). Each blood sample was analyzed in duplicate
on the Hemoscreen and Sysmex XN-10, but only the first replicateHemoscreen
results was used for all data analyses.
Bias was determined based on the results of the Deming regression model. For the
regression analysis, the 95% confidence intervals (CI) and predicted bias/difference
for each parameter was determined by sites and all sites combined. All results were
within the pre-defined acceptance criteria with the exception of the basophil
parameters.

Correlation of HemoScreen vs. Sysmex XN-10 -All sites combined

Correlation Intercept Slope
Parameter Result Range
Coefficient (95% CI) (95% CI)
WBC -0.256 1.040
0.77 to 78.09 0.993
(103/μL) (-0.396, -0.116) (1.019, 1.061)
RBC 0.021 1.000
1.15 to 7.91 0.989
(106/μL) (-0.047, 0.088) (0.983, 1.016)
-0.334 1.038
HGB (g/dL) 3.94 to 24.20 0.985
(-0.549, -0.119) (1.019, 1.056)
-0.184 1.036
HCT (%) 12.80 to 74.45 0.982
(-0.872, 0.505) (1.017, 1.056)
-2.367 1.053
MCV (fL) 54.20 to 131.38 0.956
(-6.216, 1.482) (1.009, 1.096)
0.131 0.998
MCH (pg) 15.47 to 44.00 0.957
(-0.560, 0.822) (0.974, 1.021)
MCHC 8.309 0.727
27.78 to 37.12 0.675
(g/dL) (5.921, 10.697) (0.655, 0.799)
0.504 0.965
RDW (%) 11.94 to 31.29 0.946
(-0.018, 1.025) (0.928, 1.002
PLT -6.581 1.093
20.17 to 771.57 0.967
(103/μL) (-10.494, -2.668) (1.068, 1.118)
0.043 1.016
MPV (fL) 8.73 to 20.28 0.831
(-0.660, 0.745) (0.949, 1.082)
NEUT# 0.026 1.032
0.18 to 64.05 0.989
(103/μL) (-0.069, 0.120) (1.007, 1.057)
LYMPH# -0.003 1.058
0.06 to 70.89 0.997
(103/μL) (-0.037, 0.032) (1.035, 1.082)
MONO# -0.014 0.781
0.01 to 24.55 0.718
(103/μL) (-0.077, 0.049) (0.671, 0.892)
EO# 0.00 to 2.97 0.981 -0.002 0.984
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 Correlation Intercept Slope
Parameter Result Range
Coefficient (95% CI) (95% CI)
(103/μL) (-0.007, 0.003) (0.915, 1.053)
BASO# -0.002 0.240
0.00 to 0.21 0.055
(103/μL) (-0.005, 0.001) (0.166, 0.330)
2.161 0.996
NEUT% 6.91 to 97.45 0.984
(1.182, 3.139) (0.978, 1.014)
0.411 1.029
LYMPH% 1.37 to 90.78 0.991
(-0.011, 0.833) (1.007, 1.051)
-0.370 0.809
MONO% 0.51 to 42.06 0.780
(-1.271, 0.531) (0.693, 0.924)
0.005 0.949
EO% 0.00 to 24.07 0.981
(-0.002, 0.013) (0.893, 1.006)
-0.009 0.214
BASO% 0.00 to 2.24 0.098
(-0.044, 0.023) (0.148, 0.293)

For the comparison of the HemoScreen to the Sysmex XN-10, the range of results
was limited to 0.00–2.24; therefore, an additional method comparison study was
conducted to evaluate the WBC differential parameters with elevated basophils. This
study was conducted at one site with 95 whole blood samples (2–88 years of age, 39
females and 56 males) comparing the HemoScreen to manual light microscopy (400
cells per blood film) for basophil percentages. The WBC differential absolute counts
were compared to the Sysmex XN-10. Deming linear regression analysis was used to
calculate the correlation coefficient, slope and intercept along with the 95% CI. The
results met the pre-defined acceptance criteria.

WBC differential analysis with elevated basophil samples

Correlation Intercept Slope
Parameter Result Range Comparator
Coefficient (95% CI) (95% CI)
NEUT# -0.005 0.962
0.49 to 27.74 Sysmex 0.988
(103/μL) (-0.122, 0.111) (0.921, 1.002)
LYMPH# 0.022 1.159
0.12 to 23.75 Sysmex 0.982
(103/μL) (-0.119, 0.162) (1.025, 1.294)
MONO# 0.014 0.955
0.08 to 7.04 Sysmex 0.930
(103/μL) (-0.035, 0.062) (0.846, 1.064)
EO# 0.006 1.082
0.00 to 1.71 Sysmex 0.940
(103/μL) (0.001, 0.011) (0.918, 1.247)
BASO# 0.007 0.866
0.00 to 1.69 Sysmex 0.484
(103/μL) (-0.008, 0.023) (0.333, 1.398)
7.477 0.768
NEU% 13.89 to 92.56 Blood Smear 0.916
(-16.142, 31.096) (0.381, 1.155)
1.456 1.214
LYMPH% 1.52 to 82.49 Blood Smear 0.921
(-0.595, 3.507) (1.041, 1.388)
1.190 1.230
MONO% 1.25 to 45.43 Blood Smear 0.762
(0.221, 2.159) (1.036, 1.423)
0.022 1.342
EO% 0.00 to 19.50 Blood Smear 0.915
(-0.031, 0.075) (1.016, 1.668)
0.334 0.466
BASO% 0.13 to 12.22 Blood Smear 0.725
(0.260, 0.408) (0.209, 0.724)

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 Flagging studies

The WBC flagging rate for HemoScreen was compared to the WBC differential
results displayed by the Sysmex XN and CellaVision for 460 samples. Three blood
film slides were prepared for each sample for measurement on the CellaVision (2
slides/200 cells counted per slide for a total of 400 cells). Competent operators trained
to use the CellaVision performed the differentials, and the results were verified by
these operators. Two types of abnormalities were evaluated: (1) distributional
abnormal samples, which are samples where the quantity of at least one of the
parameters resides outside of the normal concentrations, and (2) morphological
abnormal samples, which are samples that contain atypical forms of the normal cell
types contained in ordinary blood samples.

Overall WBC Flagging, HemoScreen versus Predicate

All Sites 95% CI
Positive Percent Agreement 95.9 (93.0, 97.9)
Negative Percent Agreement 82.1 (73.4, 88.8)
% Overall Agreement 92.3 (89.2, 94.7)

Overall WBC Flagging, HemoScreen versus Blood Smear

All Sites 95% CI
Positive Percent Agreement 93.8 (90.3, 96.3)
Negative Percent Agreement 71.7 (62.4, 79.8)
% Overall Agreement 87.6 (83.9, 90.6)

b. Precision/Reproducibility:

Repeatability-Whole blood

Two short term precision studies were conducted across three sites (one internal site
and 2 POC sites) with POC operators to assess within-run precision (repeatability) in
accordance with the CLSI EP05-A3 approved guideline. Sixty-five K2EDTA whole
blood samples that spanned the analytical measuring range and medical decision
levels were assayed 15 times and for all 20 parameters. All results met the pre-
defined acceptance criteria.

Reproducibility-Whole blood

The study was conducted at three sites, over five days with five replicates per run
using a 3-level control set comprising low, normal and high levels of measurands.
The data generated from this assessment was used to calculate, between-day and
between-run precision, between-laboratory precision (includes variability of different
systems and operators), and reproducibility (total precision). For each reported
parameter and for each level of control tested, the mean, SD and %CV of the various
9
components of precision were calculated along with the 95% CI of the SD and %CV
for repeatability and reproducibility (total precision). The results were analyzed in
accordance with the CLSI EP05-A3 approved guideline and met the pre-acceptance
defined criteria.

All Sites Combined Between-run Between-Day Between-site Total

Measurand Level Mean SD %CV SD %CV SD %CV SD %CV
WBC Low 2.82 0.203 7.2% 0.000 0.0% 0.116 4.1% 0.234 8.3%
WBC Normal 8.98 0.424 4.7% 0.078 0.9% 0.234 2.6% 0.490 5.5%
WBC High 20.62 0.802 3.9% 0.219 1.1% 0.355 1.7% 0.904 4.4%
RBC Low 2.66 0.052 1.9% 0.011 0.4% 0.040 1.5% 0.066 2.5%
RBC Normal 4.93 0.096 1.9% 0.016 0.3% 0.065 1.3% 0.117 2.4%
RBC High 5.92 0.108 1.8% 0.020 0.3% 0.038 0.6% 0.116 2.0%
HGB Low 7.01 0.168 2.4% 0.049 0.7% 0.045 0.6% 0.181 2.6%
HGB Normal 15.48 0.430 2.8% 0.078 0.5% 0.075 0.5% 0.444 2.9%
HGB High 22.04 0.469 2.1% 0.076 0.3% 0.073 0.3% 0.481 2.2%
HCT Low 19.01 0.376 2.0% 0.073 0.4% 0.340 1.8% 0.512 2.7%
HCT Normal 40.48 0.819 2.0% 0.080 0.2% 0.567 1.4% 0.999 2.5%
HCT High 57.32 1.077 1.9% 0.214 0.4% 0.334 0.6% 1.148 2.0%
MCV Low 71.42 0.438 0.6% 0.000 0.0% 0.506 0.7% 0.669 0.9%
MCV Normal 82.19 0.526 0.6% 0.000 0.0% 0.273 0.3% 0.593 0.7%
MCV High 96.90 0.486 0.5% 0.116 0.1% 0.280 0.3% 0.573 0.6%
MCH Low 26.32 0.465 1.8% 0.000 0.0% 0.218 0.8% 0.513 1.9%
MCH Normal 31.43 0.442 1.4% 0.084 0.3% 0.198 0.6% 0.492 1.6%
MCH High 37.26 0.402 1.1% 0.070 0.2% 0.319 0.9% 0.518 1.4%
MCHC Low 36.86 0.764 2.1% 0.023 0.1% 0.502 1.4% 0.915 2.5%
MCHC Normal 38.24 0.648 1.7% 0.111 0.3% 0.312 0.8% 0.727 1.9%
MCHC High 38.46 0.491 1.3% 0.125 0.3% 0.379 1.0% 0.633 1.6%
RDW Low 13.80 0.114 0.8% 0.000 0.0% 0.112 0.8% 0.160 1.2%
RDW Normal 16.57 0.072 0.4% 0.000 0.0% 0.129 0.8% 0.148 0.9%
RDW High 13.79 0.193 1.4% 0.097 0.7% 0.180 1.3% 0.281 2.0%
PLT Low 70.71 3.408 4.8% 1.329 1.9% 4.222 6.0% 5.586 7.9%
PLT Normal 269.42 9.208 3.4% 3.300 1.2% 11.328 4.2% 14.967 5.6%
PLT High 567.99 17.348 3.1% 2.958 0.5% 14.760 2.6% 22.969 4.0%
MPV Low 9.91 0.084 0.8% 0.000 0.0% 0.057 0.6% 0.101 1.0%
MPV Normal 9.82 0.069 0.7% 0.014 0.1% 0.051 0.5% 0.087 0.9%
MPV High 9.98 0.062 0.6% 0.004 0.0% 0.051 0.5% 0.080 0.8%
NEU# Low 1.48 0.120 8.1% 0.010 0.7% 0.043 2.9% 0.128 8.6%
NEU# Normal 4.44 0.221 5.0% 0.000 0.0% 0.000 0.0% 0.221 5.0%
NEU# High 9.17 0.544 5.9% 0.107 1.2% 0.532 5.8% 0.768 8.4%
LYM# Low 0.97 0.094 9.6% 0.000 0.0% 0.070 7.2% 0.117 12.0%
LYM# Normal 3.34 0.211 6.3% 0.098 2.9% 0.232 7.0% 0.329 9.8%
LYM# High 9.02 0.640 7.1% 0.150 1.7% 0.737 8.2% 0.987 10.9%
MON# Low 0.25 0.040 15.6% 0.012 4.7% 0.000 0.0% 0.042 16.3%
MON# Normal 0.86 0.078 9.1% 0.000 0.0% 0.013 1.5% 0.079 9.2%
MON# High 1.66 0.126 7.6% 0.000 0.0% 0.025 1.5% 0.129 7.8%
EOS# Low 0.10 0.020 21.2% 0.000 0.0% 0.000 0.0% 0.020 21.2%
EOS# Normal 0.30 0.041 13.7% 0.000 0.0% 0.007 2.4% 0.042 13.9%
EOS# High 0.69 0.059 8.5% 0.000 0.0% 0.012 1.8% 0.060 8.7%
BAS# Low 0.01 0.002 15.3% 0.000 2.5% 0.001 4.5% 0.002 16.1%
BAS# Normal 0.04 0.004 10.0% 0.000 0.0% 0.002 4.0% 0.004 10.8%

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 All Sites Combined Between-run Between-Day Between-site Total
Measurand Level Mean SD %CV SD %CV SD %CV SD %CV
BAS# High 0.09 0.005 6.3% 0.001 1.4% 0.002 2.5% 0.006 6.9%
NEU% Low 52.57 2.002 3.8% 0.000 0.0% 0.419 0.8% 2.046 3.9%
NEU% Normal 49.49 1.340 2.7% 0.443 0.9% 1.388 2.8% 1.979 4.0%
NEU% High 44.48 2.313 5.2% 0.240 0.5% 2.893 6.5% 3.712 8.3%
LYM% Low 34.55 2.022 5.9% 0.357 1.0% 1.000 2.9% 2.284 6.6%
LYM% Normal 37.16 1.237 3.3% 0.641 1.7% 1.584 4.3% 2.109 5.7%
LYM% High 43.73 2.421 5.5% 0.383 0.9% 3.017 6.9% 3.888 8.9%
MON% Low 9.04 1.276 14.1% 0.383 4.2% 0.259 2.9% 1.357 15.0%
MON% Normal 9.56 0.777 8.1% 0.120 1.3% 0.273 2.9% 0.832 8.7%
MON% High 8.05 0.458 5.7% 0.000 0.0% 0.102 1.3% 0.469 5.8%
EOS% Low 3.42 0.698 20.4% 0.000 0.0% 0.025 0.7% 0.699 20.4%
EOS% Normal 3.37 0.438 13.0% 0.000 0.0% 0.000 0.0% 0.438 13.0%
EOS% High 3.33 0.249 7.5% 0.000 0.0% 0.120 3.6% 0.276 8.3%
BAS% Low 0.42 0.052 12.4% 0.011 2.6% 0.000 0.0% 0.053 12.7%
BAS% Normal 0.42 0.038 9.2% 0.000 0.0% 0.005 1.2% 0.039 9.2%
BAS% High 0.41 0.021 5.0% 0.000 0.0% 0.001 0.3% 0.021 5.0%

c. Linearity:

Linearity was defined for WBC, RBC, HGB, HCT and PLT using 6 venous whole
blood samples. These samples were contrived to create the test panels for WBC,
RBC, HGB, HCT, and PLT to cover the specified ranges. Seven concentrations were
used for RBC/HGB and HCT, 10 concentrations were used for PLT, and 14
concentrations were used for WBC. Each concentration level was tested in duplicate
on each of the two HemoScreen analyzers.

Regression analysis was used to assess linearity for first order model (e.g. linear), and
weighted polynomial regression was used to assess linearity for second and third
order models (e.g, quadratic and cubic). PLT achieved linearity with a first order
model while for all other parameters linearity was achieved through polynomial
regression.

Measurand Analytical Measuring Range

WBC (103/µL) 0.5-80.0

RBC (106/µL) 1.0-8.8

HGB (g/dL) 3.0-25.0

HCT (%) 9.0-78.0

PLT (103/µL) 20 -800

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 d. Carryover:

Not applicable

e. Interfering Substances:

The objective of the study was to evaluate the effect of various potential interfering
substances and blood constituents on HemoScreen clinical and analytical
performance. The scope of the potential interferents included lipemia, high bilirubin,
high WBC, high PLT, and NRBCs.

There was no significant bilirubin interference up to a concentration 50 mg/dL for the

following parameters: WBC, HGB, RBC, HCT, MCV, MCH, MCHC, and RDW. For
PLT and MPV, there was no significant bilirubin interference up to a concentration of
30 mg/dL.

When blood samples with high triglycerides (319-729 mg/dL) were tested, it was
confirmed that all parameters met the claims. There was no significant interference
detected when evaluated at this concentration.

For high white blood cell (up to 317 x103/μL) and platelet (up to 2,045 x103/μL)
concentrations, no significant bias was observed in any of the evaluated parameters
and no significant NRBC interference was noted.

2. Other Supportive Instrument Performance Data Not Covered Above:

a. Limits of Detection, Blank, and Quantitation (LoD, LoB, and LoQ)

Limit of blank was determined using five plasma depleted residual normal venous
blood samples. Each of the five plasma samples were assayed six times on two
HemoScreen devices for a total of 60 measurements per parameter, using three
cartridge and sampler lots. The study results are provided in the following table.

Parameter LoB
WBC 0.0 x 103/μL
RBC 0.0 x 106/µL
HGB 0.0 g/dL
HCT 0.0%
PLT 0.0 x 103/μL

To determine the LoD and LoQ for WBC, RBC, HGB, HCT and PLT, five low level
samples were derived from native whole blood. Each of the prepared samples was
assayed six times on each of the two HemoScreen devices for a total of 60
measurements. The results of the LoD and LoQ are provided in the table below.
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 Parameter Units LoD LoQ
WBC x 103/µL 0.2 0.51
RBC x 106/µL 0.03 0.65
HGB g/dL 0.11 1.87
HCT % 0.28 5.66
3
PLT x 10 /µL 4.57 4.57

b. Capillary and venous whole blood comparison studies

This study was conducted to demonstrate comparability between capillary and venous
blood from the same subject tested on the HemoScreen. This study was performed
using 75 paired normal and abnormal whole blood samples that included clinical
decision points for WBC, HGB, and PLT from three clinical sites. Blood was drawn
twice from each donor, once via venipuncture (venous) and once via fingerstick
(capillary). For all samples, results from the HemoScreen were comparable for
capillary and venous blood. The venous whole blood sample results were compared
to the corresponding results of the capillary samples for the same donor. All results
met the pre-defined acceptance criteria.

c. Reference Intervals

Adult reference range

The normal adult reference interval for all parameters reported by the HemoScreen
analyzer was established by analyzing venous whole blood samples collected in
K2EDTA from a total population of 243 healthy individuals (N=120 males, N=123
females) collected at one site. Results were established by calculating the non-
parametric 95% confidence interval (2.5th to 97.5th percentiles). The calculated
normal reference ranges are listed below.

Female (n=123) Male (n=120)

Parameter
Lower Limit Upper Limit Lower Limit Upper Limit
WBC (103/μL) 4.0 11.5 3.6 10.2
RBC (106/μL) 3.6 5.1 4.2 6.0
HGB (g/dL) 10.8 15.6 12.5 17.6
HCT (%) 32.9 45.6 39.0 52.0
MCV (fL) 78.1 99.2 74.9 98.0
MCH (pg) 24.4 32.8 23.8 32.8
MCHC (g/dL) 30.7 34.7 30.9 35.6
RDW (%) 11.7 16.1 11.8 14.9
PLT (103/μL) 179 450 141 437
MPV (fL) 9.6 14.0 9.3 15.9
NEUT# (103/μL) 1.8 8.4 1.7 7.4
LYMPH# (103/μL) 1.3 3.9 1.2 3.8
MONO# (103/μL) 0.1 0.6 0.1 0.8
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 Female (n=123) Male (n=120)
Parameter
Lower Limit Upper Limit Lower Limit Upper Limit
EO# (103/μL) 0.0 0.4 0.0 0.5
BASO# (103/μL) 0.00 0.03 0.00 0.02
NEUT% 41.0 79.6 34.7 73.4
LYMPH% 16.7 51.7 20.7 56.9
MONO% 1.7 7.5 1.7 9.4
EO% 0.3 5.9 0.3 7.7
BASO% 0.0 0.3 0.0 0.4

Pediatric reference range

A peer review literature reference range was provided for the pediatric population,
Soldin S, Brugnara C, Wong E (eds.) (2007): Pediatric reference intervals. 6th ed.
AACC Press, Washington, DC, 217-71.

d. Sample Stability

Sample stability was determined for 18 freshly collected venous normal and abnormal
blood samples. The venous blood samples were collected into K2EDTA tubes. The
samples were subsequently kept at room temperature (20–25°C) and were analyzed
again, in duplicate at the following time points: 2 hours, 4 hours, 6 hours, 7 hours and
8 hours. For each time point, results were compared to the respective baseline results.
The data at each time point met the acceptance criteria. The data support a sample
stability claim of 7 hours at room temperature.

e. Shipping and shelf life stability

The objective of this combined study was to evaluate the reagent cartridges and
samplers (the system’s disposable components). The packaging/shipping integrity,
and shelf life claims of HemoScreen reagent cartridges along with the potential
environmental effects that could be encountered during shipment under routine
storage conditions (room temperature) were assessed.

Three cartridge lots were used for the environmental testing and for the shelf life
testing (3.5 months, 6.5 months and 7 months): There was no significant effect on
HemoScreen performance when comparing 3.5 month, 6.5 month and 7 month aged
cartridges to newly produced cartridges. The results from all evaluations performed
during this study met the predefined acceptance criteria. The data support a stability
claim for 6.5 month for the system’s disposable components.

K. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Parts 801 and 809.10.

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L. Conclusion:

The submitted information in this premarket notification is complete and supports a

substantial equivalence decision.

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