HemoScreen Hematology Analyzer
Device Facts
| Record ID | K240636 |
|---|---|
| Device Name | HemoScreen Hematology Analyzer |
| Applicant | Pixcell Medical Technologies |
| Product Code | GKZ · Hematology |
| Decision Date | May 2, 2024 |
| Decision | SESE |
| Submission Type | Abbreviated |
| Regulation | 21 CFR 864.5220 |
| Device Class | Class 2 |
| Attributes | Pediatric |
AI Performance
| Output | Algorithm | Acceptance | Observed | Dev DS | Dev Readers | Test DS | Test Readers |
|---|---|---|---|---|---|---|---|
| White Blood Cell (WBC) count | Machine vision algorithms | — | Correlation coefficient (r) = 0.995; Intercept = -0.035; Slope = 1.001 | — | — | Method comparison study: 232 residual whole blood venous samples | — |
| Platelet (PLT) count | Machine vision algorithms | — | Correlation coefficient (r) = 0.991; Intercept = 0.317; Slope = 0.985 | — | — | Method comparison study: 232 residual whole blood venous samples | — |
Indications 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.
Device Story
HemoScreen is a tabletop POC automated hematology analyzer; uses viscoelastic focusing to align cells in a microfluidic cartridge; captures high-resolution microscopic images of flowing cells; utilizes machine vision algorithms to differentiate and count cell types; WBCs stained in-cartridge for subtype differentiation; HGB calculated from optical density of individual cells. System includes reader, disposable cartridge with reagents, and sampler. Operated by clinicians in labs or POC settings. Provides quantitative CBC and 5-part differential results. Enables rapid hematological assessment to support clinical decision-making.
Clinical Evidence
Bench-only study. Method comparison conducted with 232 residual venous whole blood samples against Sysmex XN-Series analyzers. Correlation coefficients (r) for WBC and PLT were 0.995 and 0.991, respectively. Passing-Bablok regression confirmed performance within acceptance criteria across extended ranges. LoB, LoD, and LoQ determined per CLSI EP17-A2.
Technological Characteristics
Tabletop automated hematology analyzer using viscoelastic focusing for cell alignment. Employs microfluidic chambers and high-resolution microscopic imaging. Reagents contained within disposable cartridges. Connectivity via USB export and printer interface. Factory calibrated. Software-driven analysis of stained cells. Dimensions/form factor: tabletop reader.
Indications for Use
Indicated for adults and children ≥2 years for enumeration and classification of CBC parameters and 5-part leukocyte differential in capillary or venous K2EDTA whole blood.
Regulatory Classification
Identification
An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.
Special Controls
*Classification.* Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.”
Predicate Devices
- HemoScreen Hematology Analyzer (K222148)
Reference Devices
- Sysmex XN-Series (XN-10, XN-20) Automated Hematology Analyzers (K112605)
Submission Summary (Full Text)
{0}
FDA
U.S. FOOD & DRUG
ADMINISTRATION
# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
INSTRUMENT ONLY
## I Background Information:
A 510(k) Number
K240636
B Applicant
PixCell Medical Technologies
C Proprietary and Established Names
HemoScreen Hematology Analyzer
D Regulatory Information
| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| GKZ | Class II | 21 CFR 864.5220 - Automated Differential Cell Counter | HE - Hematology |
## II Submission/Device Overview:
A Purpose for Submission:
The purpose of the submission is to extend the analytical measurement range for platelets (PLT) and white blood cell (WBC) counts
B Type of Test:
Quantitative complete blood count with 5-part leukocyte differential: Red Blood Cells (RBC), White Blood Cells (WBC), Platelets (PLT), Hemoglobin (HGB), Hematocrit (HCT), Mean Corpuscular Volume (MCV), Mean Cell Hemoglobin (MCH), Mean Cell Hemoglobin Concentration (MCHC), Red Blood Cell Distribution Width (RDW), Mean Platelets Volume (MPV), Neutrophils (NEUT; #/%), Monocytes (MONO; #/%), Lymphocytes (LYMP; #/%), Eosinophils (EO; #/% and Basophils (BASO; #/%)
## III Intended Use/Indications for Use:
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
{1}
K240636 - Page 2 of 8
A Intended Use(s):
See Indications for Use below.
B 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.
C Special Conditions for Use Statement(s):
Rx - For Prescription Use Only
IV Device/System Characteristics:
A Device Description:
The HemoScreen is a point-of-care (POC), automated hematology analyzer that provides results for complete blood count (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 plus software), cartridge with preloaded reagents, blood collection 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 viscoelastic focusing, lysis of RBC, and 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.
The HemoScreen provides the following blood count parameters: red blood cells (RBC), white blood cells (WBC), platelets (PLT), hemoglobin (HGB), hematocrit (HCT), mean corpuscular (erythrocyte) volume (MCV), mean cell (erythrocyte) hemoglobin (MCH), mean cell (erythrocyte) hemoglobin concentration (MCHC), red blood cell distribution width (RDW), mean platelets volume (MPV), neutrophils (NEUT; #/%), monocytes (MONO; #/%), lymphocytes (LYMP; #/%), eosinophils (EO; #/% ) and basophiles (BASO; #/%). Of these, RBC, WBC, PLT, MCH, MCV, RDW, MPV, NEUT%, MONO%, LYMP%, EO%, and BASO% are quantitated by direct measurement, and HCT, HGB, MCHC, NEUT#, MONO#, LYMPH#, EO#, and BASO# are calculated from the direct measurements.
B Instrument Description Information:
1. Instrument Name:
HemoScreen Hematology Analyzer
2. Specimen Identification:
{2}
Specimen identification is performed by manual keyboard entry or use of a barcode reader.
# 3. 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. The blood is collected in an K2EDTA microtube (indirect sampling) which is then taken into Sampler or directly from fingertip drawn into Sampler (direct sampling). Venous blood, thoroughly mixed and at room temperature, can be used as well.
# 4. Calibration:
Factory calibration. The calibration of HemoScreen is traceable to the reference methods described in CLSI H26-A2.
# 5. Quality Control:
The HemoScreen system includes both on-board internal and external quality controls. Internal quality control includes built-in self-tests, whereby the software verifies performance of the optics, reagent mixing, and instrument pneumatics. Every time the analyzer is turned on, and before each measurement, it automatically verifies conformance to the measurement specifications. Furthermore, internal self-testing occurs after the cartridge has been inserted, thus validating the integrity of the disposable unit. The intensity and spectrum of all illumination sources are tested using corresponding sensors, and the optical properties of each cartridge are inspected automatically prior to each test.
Liquid Quality Controls (PIX-CBC): PIX-CBC Hematology Controls, 3-level commercial liquid quality controls are used to cover all HemoScreen parameters. CBC-PIX is a reagent composed of human erythrocytes and mammalian leukocytes and platelets suspended in a plasma-like fluid with preservatives. PIX-CBC whole blood controls (Cat No. PIX002) are produced by R&D Systems, a Bio-Techne brand, Minneapolis, MN.
# V Substantial Equivalence Information:
# A Predicate Device Name(s):
HemoScreen Hematology Analyzer
# B Predicate 510(k) Number(s):
K222148
# C Comparison with Predicate(s):
| Device & Predicate Device(s): | K240636 | K222148 |
| --- | --- | --- |
| Device Trade Name | HemoScreen Hematology Analyzer | Same |
| General Device Characteristic Similarities | | |
K240636 - Page 3 of 8
{3}
| Intended Use/Indications 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 (K_{2}EDTA 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. | Same |
| --- | --- | --- |
| Parameters Measured | Red blood cells (RBC), White blood cells (WBC), Platelets (PLT), Hemoglobin (HGB), Hematocrit (HCT), Mean Corpuscular (erythrocyte) Volume (MCV), Mean Cell (erythrocyte) Hemoglobin (MCH), Mean cell (erythrocyte) Hemoglobin Concentration (MCHC), Red blood cell Distribution width (RDW)-CV Mean Platelets Volume (MPV), Neutrophils (NEUT; #/%), Monocytes (MONO; #/%), Lymphocytes (LYMP; #/%), Eosinophils (EO; #/%) and Basophiles (BASO; #/%) | Same |
| Throughput | 10 samples/hour | Same |
| Test Principle | The HemoScreen uses a novel focusing method called viscoelastic focusing which causes the cells to perfectly align into a plane. High resolution microscopic images are taken of the flowing cells. Each image is analyzed using machine vision algorithms and the different cell types are differentiated and counted. WBCs are stained prior to analysis so as to enable differentiation between their subtypes and abnormal cells. Hb is calculated based on the optical density measured on intact individual | Same |
K240636 - Page 4 of 8
{4}
| | cells. | |
| --- | --- | --- |
| Calibration | Factory calibrated | Same |
| Sample Type | Anticoagulated whole blood | Same |
| Sample Type- venous | K_{2}EDTA anticoagulated whole blood | Same |
| Sample Type-fingerstick | Direct and indirect
Direct: Capillary blood from fingertip drawn directly into Sampler.
Indirect: Capillary blood from fingertip delivered to microtainer, then transferred into Sampler | Same |
| Sample Volume | 40 μL | Same |
| General Device Characteristic Differences | | |
| Analytical Measuring Range (AMR) for WBC and PLT | WBC: 0.25–95 x 10^{3}/μL
PLT: 7–988 x 10^{3}/μL | WBC: 0.5–80 x 10^{3}/μL
PLT: 20–800 x 10^{3}/μL |
| Software Version | 2.1.1 | 2.0.8 |
VI Standards/Guidance Documents Referenced:
CLSI EP06, 2nd Ed: Evaluation of Linearity of Quantitative Measurement Procedures; Approved guideline – Second edition, 2020
CLSI EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved guideline, 2012
VII Performance Characteristics (if/when applicable):
A Analytical Performance:
1. Precision/Reproducibility:
Please refer to K222148 and K180020.
2. Linearity:
The study was performed based on the recommendations of CLSI EP06, 2nd Edition. Linearity was defined for WBC and PLT by using serial dilutions prepared from the commercial linearity controls (PIX-LINE). Samples with ten levels were measured in seven replicates on a single HemoScreen analyzer. Results were examined for outliers and other potential problematic values. Linearity analysis was based on expected values at each sample
K240636 - Page 5 of 8
{5}
level. WBC and PLT parameters were confirmed to be linear across all tested points across the measuring ranges. The new ranges are presented in the table below.
| Measurand | Linearity | Analytical Measuring Range |
| --- | --- | --- |
| WBC (103/μL) | 0.25 – 95.0 | 0.25 – 95.0 |
| PLT (103/μL) | 7.0 – 988.0 | 7.0 – 988.0 |
# 3. Analytical Specificity/Interference:
Please refer to K180020.
# 4. Accuracy (Instrument):
A method comparison study was conducted at one site to assess the performance of the HemoScreen compared to Sysmex XN-Series (XN-10, XN-20) Automated Hematology Analyzers (K112605) with the extended PLT and WBC ranges. A total of 232 residual whole blood venous samples that span the HemoScreen extended linear ranges and medical decision points were selected. The data were evaluated by Passing-Bablok regression and Pearson's correlation for all 20 parameters. For the regression analysis, the $95\%$ confidence intervals (CI) and predicted bias/difference for each parameter were determined and the summarized data are provided below. All results were within the pre-defined acceptance criteria.
Passing-Bablok regression and Pearson's correlation of HemoScreen vs. Sysmex XN
| Parameter | Result Range | Correlation Coefficient (r) | Intercept (95% CI) | Slope (95% CI) |
| --- | --- | --- | --- | --- |
| WBC (103/μL) | 0.29–94.77 | 0.995 | -0.035 (-0.114, 0.027) | 1.001 (0.992, 1.012) |
| RBC (106/μL) | 1.91–7.13 | 0.997 | 0.023 (-0.015, 0.063) | 0.998 (0.988, 1.009) |
| HGB (g/dL) | 5.65–20.72 | 0.995 | -0.006 (-0.153, 0.137) | 0.993 (0.982, 1.005) |
| HCT (%) | 16.42–62.73 | 0.990 | -0.180 (-0.816, 0.385) | 1.006 (0.991, 1.022) |
| MCV (fL) | 53.33–111.47 | 0.928 | 1.818 (-2.268, 6.512) | 0.979 (0.927, 1.025) |
| MCH (pg) | 16.94–37.24 | 0.970 | 0.970 (0.428, 1.476) | 0.953 (0.936, 0.973) |
| MCHC (g/dL) | 30.90–36.06 | 0.654 | 10.582 (8.171, 13.072) | 0.677 (0.603, 0.748) |
| RDW (%) | 11.32–27.34 | 0.911 | 0.411 (-0.508, 1.273) | 0.955 (0.889, 1.025) |
| PLT (103/μL) | 9.25–930.66 | 0.991 | 0.317 (-3.176, 3.524) | 0.985 (0.966, 1.004) |
| MPV (fL) | 9.27–14.46 | 0.825 | -0.432 (-1.329, 0.505) | 1.055 (0.967, 1.138) |
| NEUT # (103/μL) | 0.00–83.11 | 0.994 | -0.042 (-0.130, 0.011) | 1.017 (0.999, 1.033) |
| RBC (106/μL) | 0.00–10.00 | 0.999 | 0.000 (-0.000, 0.000) | 0.999 (0.998, 1.000) |
K240636 - Page 6 of 8
{6}
| Parameter | Result Range | Correlation Coefficient (r) | Intercept (95% CI) | Slope (95% CI) |
| --- | --- | --- | --- | --- |
| LYMP # (103/μL) | 0.01–72.19 | 0.947 | 0.011 (-0.025, 0.053) | 0.998 (0.968, 1.033) |
| MONO # (103/μL) | 0.01–9.48 | 0.930 | -0.006 (-0.031, 0.007) | 1.006 (0.964, 1.056) |
| EO # (103/μL) | 0.00–4.10 | 0.946 | 0.008 (0.004, 0.012) | 0.998 (0.966, 1.031) |
| BASO # (103/μL) | 0.00–0.77 | 0.415 | -0.006 (-0.016, -0.001) | 0.758 (0.593, 0.996) |
| NEUT (%) | 0.90–98.20 | 0.961 | 0.158 (-1.138, 1.465) | 1.012 (0.991, 1.033) |
| LYMP (%) | 1.30–93.10 | 0.980 | 0.717 (0.395, 1.139) | 0.986 (0.967, 1.005) |
| MONO (%) | 0.10–45.80 | 0.877 | -0.146 (-0.581, 0.255) | 1.005 (0.947, 1.061) |
| EO (%) | 0.00–34.10 | 0.855 | 0.087 (0.032, 0.100) | 1.016 (1.000, 1.046) |
| BASO (%) | 0.00–6.50 | 0.277 | -0.076 (-0.193, -0.020) | 0.764 (0.628, 0.967) |
# 5. Carry-Over:
Not applicable
# B Other Supportive Instrument Performance Characteristics Data:
Limits of Detection, Blank, and Quantitation (LoD, LoB, and LoQ)
Five residual normal venous blood samples (from both morphological and cell distribution aspects) were centrifuged to deplete the plasma supernatant of RBCs, WBCs and PLTs. Each of the five plasma samples was assayed six times on two HemoScreen devices for a total of 60 measurements per parameter, using three cartridge and sampler lots. The limit of blank was determined by the 95th percentile of the distribution of the study variable.
To determine the LoD and LoQ for WBC and PLT, five low level samples were derived from native whole blood. Each of the five plasma samples was assayed six times on two HemoScreen devices for a total of 60 measurements per parameter, using three cartridge and sampler lots. The results for WBC and PLT were collected and used further for statistical analysis. The LoDs and LoQs were calculated in accordance with CLSI EP17-A2 using the parametric option.
Summary LoB, LoD and LoQ for WBC and PLT
| Measurand | LoB | LoD | LoQ |
| --- | --- | --- | --- |
| WBC (x103/μL) | 0.12 | 0.23 | 0.23 |
| PLT (x103/μL) | 0.52 | 2.73 | 2.73 |
K240636 - Page 7 of 8
{7}
VIII Proposed Labeling:
The labeling supports the finding of substantial equivalence for this device.
IX Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
K240636 - Page 8 of 8
