BD FACSPresto System, BD FACSPresto CD4/Hb Cartridge, BD FACSPresto CD4/Hb Cart…
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K150815 FDA 510(k)
- FDA Product Code
- PMG 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 BD FACSPresto System is an Automated Multicolor Fluorescent Imaging Cytometric Analysis System designed for hematology applications. It performs automated multicolor fluorescent imaging cytometry to quantify CD4 T lymphocytes and measure total hemoglobin concentration in whole blood samples, delivering absolute and percentage results.
The system comprises a portable instrument with integrated software, a sample incubation workstation, and single-use disposable cartridges. It is intended for near-patient use and operates as a Class II device under FDA 510(k) clearance (K150815). Cartridges are non-sterile, single-use components supplied as part of a kit, with no MRI safety considerations specified.
Frequently asked questions
What clinical measurements does the BD FACSPresto System perform, and how does it differ from traditional hematology analyzers?
The BD FACSPresto System quantifies CD4 T lymphocytes (providing absolute counts and percentages) and measures total hemoglobin concentration in whole blood samples. Unlike traditional hematology analyzers that rely on optical or electrical impedance methods, this system uses automated multicolor fluorescent imaging cytometry, enabling precise fluorescent-based analysis for these specific hematology parameters. It is designed for near-patient use, making it suitable for point-of-care or decentralized testing environments.
Are the BD FACSPresto CD4/Hb Cartridges reusable, and if not, how should they be handled after use?
The cartridges are explicitly labeled as single-use, non-sterile components. After use, they should be disposed of according to local biohazard waste protocols. Since they are designed for one-time use, reuse is not supported by the manufacturer to ensure accuracy and prevent cross-contamination.
What is the intended use environment for the BD FACSPresto System, and does it require any special infrastructure?
The system is intended for near-patient use, meaning it is portable and designed to operate in clinical settings where immediate results are needed, such as outpatient clinics, physician offices, or decentralized testing sites. It includes an integrated software interface and a sample incubation workstation, but no additional infrastructure (like MRI compatibility) is required. The portable design eliminates the need for a fixed laboratory setup.
How are the BD FACSPresto CD4/Hb Cartridge Kits supplied, and what should be considered when storing them?
The cartridges are supplied as part of a kit, which includes the single-use, non-sterile components necessary for testing. Since they are non-sterile, they should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Proper labeling and inventory tracking are recommended to ensure usability within the manufacturer’s specified shelf life.
What regulatory pathway was followed for FDA clearance of the BD FACSPresto System, and which advisory committee reviewed it?
The BD FACSPresto System received FDA 510(k) clearance under the Traditional 510(k) pathway, with a Substantially Equivalent (SESE) determination. The review was conducted by the Hematology (HE) Advisory Committee as part of the Immunology and Microbiology (IM) Panel, with the submission filed under product code PMG (Point-of-Care Testing). The clearance date was December 17, 2015.
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: BD FACSPresto™ System | Portable Cell Analyzer | CD4 Testing, BD FACSPresto Instrument System, BD Biosciences | BD FACSPresto
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K150815 | Class II | Active |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
Sources (1)
- FDA 510(k) K150815 24 fields · synced Sep 18, 2026