BD Veritor System for Rapid Detection of Flu A+B
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K112277 FDA 510(k)
- FDA Product Code
- PSZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.3328 FDA 510(k)
- Regulation Number
- 866.3328 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The BD Veritor System is a rapid diagnostic device designed for the detection of influenza A and B viruses. Classified as a device detecting influenza A, B, and C virus antigens, it provides point-of-care testing to identify viral infections quickly and accurately, supporting timely clinical decision-making in microbiology settings.
This system is intended for single-use in clinical laboratory settings, including CLIA-waived environments. Supplied as a handheld device with pre-packaged test cartridges, it requires no complex setup and delivers results within minutes. The device is regulated under FDA 510(k) clearance (K112277) and adheres to medical specialty standards for microbiology diagnostics, ensuring compliance with regulatory requirements for respiratory virus detection.
Frequently asked questions
What clinical settings is the BD Veritor System approved for use in, and how does its CLIA waiver status affect its implementation?
The BD Veritor System is designed for use in clinical laboratory settings, including those with CLIA-waived status, which allows qualified personnel to perform testing without full laboratory oversight. This makes it suitable for point-of-care testing in environments like urgent care clinics, physician offices, or emergency departments where rapid influenza A+B detection is needed to support timely clinical decisions.
How is the BD Veritor System supplied, and is it intended for single-use or reusable applications?
The BD Veritor System is supplied as a handheld device paired with pre-packaged, single-use test cartridges. Each cartridge is intended for one test only, ensuring sterility and preventing cross-contamination between patients. This design eliminates the need for complex setup or maintenance, making it ideal for quick, on-site use.
What types of influenza viruses can the BD Veritor System detect, and how quickly does it provide results?
The BD Veritor System is specifically designed to detect influenza A and B viruses, though its broader regulatory classification includes influenza C. Results are delivered within minutes, enabling rapid identification of infections to inform immediate clinical actions, such as isolation or treatment decisions.
What regulatory pathway was followed for the BD Veritor System’s FDA clearance, and which advisory committee was involved?
The BD Veritor System received FDA clearance through a traditional 510(k) review process, classified as substantially equivalent to a predicate device. The review was conducted by the Microbiology (MI) Advisory Committee, ensuring compliance with medical specialty standards for respiratory virus detection before approval.
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 Veritor™ Plus System for Rapid Detection of Flu A+B, BD Veritor™ System for Rapid Detection of Flu A+B (CLIA-Waived Kit), BD Veritor™ Plus System for Rapid Detection of SARS-CoV-2, Flu A+B
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K112277 | Class II | Active |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
Sources (1)
- FDA 510(k) K112277 24 fields · synced Sep 18, 2026