HemoScreen Hematology Analyzer
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K180020 FDA 510(k)
- FDA Product Code
- GKZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 864.5220 FDA 510(k)
- Regulation Number
- 864.5220 FDA 510(k)
- Advisory Committee
- Hematology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The HemoScreen Hematology Analyzer is an automated in vitro diagnostic device classified as a Counter, Differential Cell. It performs hematological analysis, including complete blood counts and differential cell counts, using a single blood sample. The system employs AI-assisted Viscoelastic Focusing (VEF) technology to process and analyze blood cells on a disposable cartridge, delivering lab-grade results.
The device is designed for point-of-care use, requiring no maintenance or calibration. Supplied as a portable instrument, it operates in non-sterile settings and is intended for single-use cartridges. Authorized under FDA 510K and IVDR, it adheres to regulatory standards for hematology diagnostics. No MRI safety or reusable components are specified in the data.
Frequently asked questions
What types of blood tests can the HemoScreen Hematology Analyzer perform, and why is this technology important for point-of-care settings?
The HemoScreen Hematology Analyzer performs complete blood counts (CBC) and differential cell counts using a single blood sample. Its AI-assisted Viscoelastic Focusing (VEF) technology enables precise analysis of blood cells on disposable cartridges, delivering lab-grade accuracy in a portable format. This is critical for point-of-care settings because it eliminates the need for manual labor-intensive processes, reduces turnaround time, and provides reliable results where traditional lab infrastructure may be limited or unavailable.
Is the HemoScreen Hematology Analyzer designed for single-use or reusable components, and how does this affect its maintenance requirements?
The HemoScreen Hematology Analyzer is designed for single-use cartridges, meaning each cartridge is intended for one analysis and must be discarded afterward. This eliminates the need for maintenance or calibration of the device itself, as the analytical process relies entirely on the disposable cartridge. The instrument is portable and non-sterile, so its simplicity reduces operational burdens while ensuring consistent performance without the risks associated with reusable components.
What regulatory pathways does the HemoScreen Hematology Analyzer follow, and how does this impact its use in clinical environments?
The HemoScreen Hematology Analyzer is authorized under FDA 510(k) clearance and IVDR (In Vitro Diagnostic Regulation) compliance, confirming its adherence to stringent regulatory standards for hematology diagnostics. This means it has undergone rigorous validation to ensure safety, performance, and accuracy before market introduction. Clinicians can rely on its regulatory backing to trust the device’s clinical utility, particularly in settings where rapid, reliable hematological results are essential.
How is the HemoScreen Hematology Analyzer supplied, and what should clinicians consider when storing or transporting it?
The HemoScreen Hematology Analyzer is supplied as a portable, non-sterile instrument, paired with single-use disposable cartridges for analysis. Since the device itself is non-sterile and the cartridges are consumables, clinicians should store the instrument in a clean, dry environment to prevent contamination or damage. Cartridges should be kept in their original packaging until use, following manufacturer guidelines for shelf life and handling to ensure optimal performance.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: HemoScreen™ - PixCell Medical, PixCell Medical - Portable Point of Care (poct) blood diagnostics, PixCell Medical HemoScreen Analyzer 10 in. | Buy Online | PixCell ..., PixCell HemoScreen Analyzer - CLIAwaived Inc.
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K180020 | Class II | Active |
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Manufacturer
- Manufacturer
- Pixcell Medical Technologies, Ltd.
Sources (2)
- FDA 510(k) K180020 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026