BD Veritor System for SARS-CoV-2
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K243872 FDA 510(k)
- FDA Product Code
- QVF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.3982 FDA 510(k)
- Regulation Number
- 866.3982 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The BD Veritor System for SARS-CoV-2 is a simple point-of-care device designed to directly detect SARS-CoV-2 viral targets from clinical specimens in near-patient settings. Classified as a Class II medical device, it is intended for rapid diagnostic testing to identify the presence of the virus responsible for COVID-19.
This system is supplied as a single-use, handheld device with a one-button operation, enabling flexible workflows for healthcare professionals. It is authorized for use under an FDA Emergency Use Authorization and is regulated under the FDA’s 510(k) pathway, specifically under the Microbiology advisory committee. The device requires no additional sterilization as it is intended for single-use per test.
Frequently asked questions
What is the BD Veritor System for SARS-CoV-2 designed to do and where can it be used?
The BD Veritor System for SARS-CoV-2 is a point-of-care device intended to rapidly detect the presence of SARS-CoV-2 viral targets directly from clinical specimens. It is specifically designed for use in near-patient settings, such as clinics, emergency rooms, or other healthcare environments where quick results are critical. Its handheld, single-use format allows for flexible testing workflows without requiring additional sterilization.
Is the BD Veritor System for SARS-CoV-2 intended for single-use or repeated use, and why?
The BD Veritor System for SARS-CoV-2 is designed for single-use per test. This is explicitly stated in the device’s specifications, eliminating the need for sterilization between uses and ensuring hygiene and safety in point-of-care settings.
How is the BD Veritor System for SARS-CoV-2 regulated by the FDA, and what does that mean for its use?
The BD Veritor System for SARS-CoV-2 is regulated under the FDA’s 510(k) pathway, classified as a Class II medical device, and falls under the Microbiology advisory committee. It was cleared through a dual-track process, meaning it was deemed substantially equivalent to a predicate device. This regulatory route ensures it meets FDA standards for safety and effectiveness, allowing authorized use under an Emergency Use Authorization (EUA) for detecting SARS-CoV-2.
What type of clinical specimens can the BD Veritor System for SARS-CoV-2 analyze?
While the exact types of clinical specimens aren’t detailed in the provided data, the device is explicitly designed to *directly detect SARS-CoV-2 viral targets from clinical specimens*. This implies it is intended for use with specimen types commonly associated with COVID-19 testing, such as nasal swabs or other respiratory samples, though the precise compatibility would require confirmation from the manufacturer or labeling.
How easy is it to operate the BD Veritor System for SARS-CoV-2, and what does its one-button design imply for workflow?
The BD Veritor System for SARS-CoV-2 is described as a handheld device with a *one-button operation*, which simplifies its use for healthcare professionals. This design reduces the complexity of testing workflows, allowing for quicker and more efficient point-of-care testing without requiring extensive training or multiple steps. The simplicity is particularly useful in busy clinical environments where rapid results are needed.
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™ System for Rapid Detection of SARS-CoV-2, BD Veritor, BD Veritor™ Plus System for Rapid Detection of SARS-CoV-2
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K243872 | Class II | Active |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
Sources (1)
- FDA 510(k) K243872 24 fields · synced Sep 18, 2026