BD Veritor System Flu A+B Assay
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K151301 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 Flu A+B Assay is a rapid diagnostic device designed to detect influenza A and B viruses. It falls under the category of devices detecting influenza A, B, and C virus antigens, providing point-of-care testing capabilities for microbiological analysis.
This assay is intended for single-use in clinical laboratory settings, including CLIA-waived environments. It is supplied as a kit and requires no special storage conditions beyond those specified in the instructions for use. The device has received FDA clearance under a 510(k) submission, classified as a Class II medical device (PSZ product code).
Frequently asked questions
What clinical setting is the BD Veritor System Flu A+B Assay approved for use in, and what type of testing environment does it support?
The BD Veritor System Flu A+B Assay is approved for use in clinical laboratory settings, including those that qualify as CLIA-waived. This classification means it can be used in environments with limited laboratory resources, such as physician offices or urgent care clinics, where rapid influenza testing is needed without full laboratory infrastructure. The assay is designed for point-of-care testing, allowing for quick results to support immediate clinical decisions.
Is the BD Veritor System Flu A+B Assay intended for single-use or reusable applications, and what does this mean for workflow efficiency?
The BD Veritor System Flu A+B Assay is explicitly designed for single-use only. This means each test kit is meant to be used once and then discarded, which helps minimize the risk of cross-contamination and ensures accurate results. For workflow efficiency, this design implies that each patient sample requires a new kit, but it also reduces the need for cleaning or reprocessing between uses, streamlining the testing process in busy clinical environments.
What storage requirements does the BD Veritor System Flu A+B Assay have, and how does this affect its usability in different healthcare settings?
The BD Veritor System Flu A+B Assay does not require any special storage conditions beyond those outlined in the instructions for use. This means it can be stored under standard laboratory or clinical conditions, making it convenient for use in a variety of healthcare settings, including smaller clinics or facilities without climate-controlled storage. The simplicity of storage requirements also reduces logistical challenges for procurement and inventory management.
How does the regulatory pathway for the BD Veritor System Flu A+B Assay impact its adoption in clinical practice?
The BD Veritor System Flu A+B Assay received FDA clearance through a 510(k) submission, classified as a Class II medical device under the product code PSZ. This pathway confirms that the device is deemed substantially equivalent to a legally marketed predicate device, ensuring it meets regulatory standards for safety and effectiveness. For clinicians and healthcare facilities, this clearance indicates that the assay has undergone rigorous evaluation by the FDA, which can help build confidence in its reliability and performance for detecting influenza A and B viruses in point-of-care settings.
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 (company) - Wikipedia, BD Veritor™ Plus System for Rapid Detection of 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 | K151301 | Class II | Active |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
Sources (1)
- FDA 510(k) K151301 24 fields · synced Sep 18, 2026