BD Veritor System for Rapid Detection of Flu A+B
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K120049 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 molecular assay technology to identify viral antigens directly from clinical specimens, enabling timely diagnostic results for respiratory infections.
The system is intended for use in clinical laboratory settings, including CLIA-waived environments, and is supplied as a single-use cartridge-based platform. It requires no external power source beyond the handheld device itself and is classified as a Class II medical device under FDA regulations (K120049, 510(k) clearance). The device is not MRI-compatible and must be stored according to manufacturer instructions to maintain performance.
Frequently asked questions
What clinical settings is the BD Veritor System approved for use in, and why is this important for my lab?
The BD Veritor System is authorized for use in clinical laboratory settings, including CLIA-waived environments, meaning it can be operated by certified personnel in facilities with minimal regulatory oversight. This is important because it allows smaller labs or point-of-care testing areas to perform rapid influenza A and B detection without needing full laboratory infrastructure, enabling faster turnaround times for patient results.
Is the BD Veritor System designed for single-use or reusable testing, and how does this affect workflow?
The BD Veritor System is supplied as a single-use cartridge-based platform, meaning each test requires a new cartridge. This design eliminates the need for cleaning or reprocessing between uses, reducing the risk of cross-contamination and simplifying workflow by ensuring consistent performance without maintenance steps. However, it does require inventory management to ensure cartridges are available when needed.
Does the BD Veritor System require any special storage conditions, and if so, why is this important?
The BD Veritor System must be stored according to manufacturer instructions to maintain performance. While the exact conditions aren’t detailed here, proper storage typically involves protecting the cartridges from extreme temperatures, moisture, or light. This is critical because molecular assays like this one can be sensitive to environmental factors, and improper storage could lead to inaccurate results or device failure, compromising diagnostic reliability.
How does the BD Veritor System’s portability or power requirements compare to traditional influenza testing methods?
The BD Veritor System is designed as a handheld, cartridge-based platform that requires no external power source beyond the device itself, making it highly portable for use in various clinical settings. Unlike traditional PCR or other molecular assays, which often require bulky equipment and electricity, this system allows for rapid testing almost anywhere within a lab or even in some point-of-care environments, enabling quicker decision-making for patient management.
What types of clinical specimens can be tested with the BD Veritor System, and does this limit its applicability?
The BD Veritor System is intended for direct testing of clinical specimens containing influenza A and B viruses, though the exact specimen types (e.g., nasal swabs, throat swabs, or nasopharyngeal aspirates) aren’t specified here. While it’s designed for rapid detection, its applicability depends on the specimen’s suitability for molecular assay technology. Clinicians should confirm compatibility with the manufacturer’s instructions to ensure accurate results, as improper specimen handling could affect performance.
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 | K120049 | Class II | Active |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
Sources (1)
- FDA 510(k) K120049 24 fields · synced Sep 18, 2026