BD Veritor System for Rapid Detection of Flu A+B
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K132692 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 an in vitro diagnostic device designed for the rapid detection of influenza A and B viruses. It employs immunoassay technology to identify viral antigens in clinical specimens, enabling early diagnosis and management of influenza infections.
This system is intended for use in clinical laboratory settings, including point-of-care environments, and is classified as a Class II device under FDA regulations. It is a single-use, non-sterile device and requires no special storage conditions beyond those specified in the accompanying instructions. The system has received FDA 510(k) clearance under a Special review process, with a decision code of SESE.
Frequently asked questions
What clinical setting is the BD Veritor System intended for, and how does its rapid detection capability benefit patients?
The BD Veritor System is designed for use in clinical laboratory settings, including point-of-care environments, where quick diagnostic results are critical. Its immunoassay technology detects influenza A and B viral antigens rapidly, enabling early diagnosis and faster treatment initiation, which can reduce complications and hospitalizations associated with delayed influenza management.
Is the BD Veritor System reusable or single-use, and what storage requirements apply?
The BD Veritor System is a single-use device, meaning each unit is intended for one-time use only. It is non-sterile, so no special sterilization procedures are required. Storage follows standard conditions as outlined in the provided instructions, with no additional environmental controls specified beyond those typical for diagnostic devices.
How was the regulatory pathway for the BD Veritor System determined, and what does the Special Review process entail?
The BD Veritor System received FDA 510(k) clearance under a Special Review process, indicated by the decision code SESE. This route is typically used for submissions deemed to have a higher level of complexity or innovation, requiring additional scrutiny by the FDA. The system was classified as Substantially Equivalent to a predicate device, meaning it was determined to have the same intended use and technological characteristics as a previously approved device, with no significant changes in risk.
What types of clinical specimens can the BD Veritor System analyze, and how does this impact its utility in influenza testing?
While the provided data does not explicitly list specimen types, the BD Veritor System is designed for rapid detection of influenza A and B viral antigens in clinical specimens, which typically includes nasal swabs, nasopharyngeal swabs, or throat swabs. This capability allows for faster turnaround times compared to traditional laboratory methods, supporting timely clinical decision-making in point-of-care settings where influenza testing is critical.
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 | K132692 | Class II | Active |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
Sources (1)
- FDA 510(k) K132692 24 fields · synced Oct 6, 2026