BD Veritor System for Rapid Detection of Flu A+B
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K121797 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 diagnostic device designed for the rapid detection of influenza A and B viruses. It falls under the category of devices detecting viral antigens, providing results to aid in the identification of respiratory infections caused by these pathogens.
This system is intended for use in clinical microbiology laboratories and point-of-care settings. It is a single-use, non-sterile device and does not require MRI safety considerations. The system is authorized under FDA 510(k) clearance and IVDR compliance, with a product code of PSZ and regulation number 866.3328. Storage and handling follow standard laboratory protocols for diagnostic assays.
Frequently asked questions
What clinical settings is the BD Veritor System intended for use in, and why is this important for clinicians?
The BD Veritor System is designed for use in clinical microbiology laboratories and point-of-care settings, such as emergency departments, urgent care clinics, or physician offices. This dual-purpose design is important because it allows for rapid influenza A and B detection where immediate results can influence patient management—such as triaging high-risk patients or initiating antiviral therapy sooner. Point-of-care use also reduces turnaround time compared to traditional lab-based testing.
Is the BD Veritor System reusable, and if not, how does this affect workflow and cost?
The BD Veritor System is single-use only, meaning each test cartridge is intended for one use and must be discarded after testing. This design eliminates the need for cleaning or reprocessing, reducing the risk of cross-contamination and simplifying workflow. However, it may increase consumable costs over time compared to reusable devices, though the rapid turnaround time and ease of use can offset this in high-volume settings.
What storage and handling requirements should clinicians follow for the BD Veritor System?
The BD Veritor System follows standard laboratory protocols for diagnostic assays, which generally include storing test cartridges at room temperature (2°C to 30°C) and protecting them from moisture or extreme temperatures. Since it is non-sterile, clinicians should handle it with standard aseptic techniques, avoiding contamination before use. Always refer to the included instructions for specific shelf-life details and expiration markings.
How does the regulatory pathway (FDA 510(k) and IVDR) impact the reliability or trustworthiness of this device?
The BD Veritor System holds FDA 510(k) clearance and IVDR compliance, indicating it has undergone rigorous review by regulatory bodies to demonstrate substantial equivalence to a predicate device (as noted in the decision description). This means the device’s performance, safety, and effectiveness have been evaluated against established standards, providing clinicians and buyers with confidence in its clinical validity. IVDR compliance further ensures adherence to European Union diagnostic standards, broadening its applicability in global healthcare settings.
Are there any special considerations for using the BD Veritor System in environments with MRI equipment?
No special MRI safety considerations are required for the BD Veritor System, as it is not a magnetic or metallic device. This means it can be safely used in areas where MRI machines are present without interference or safety risks, such as hospitals with combined diagnostic imaging and point-of-care testing facilities.
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), Becton Dickinson – Wikipedia, BD Veritor™ Plus System for Rapid Detection of SARS-CoV-2, Flu A+B
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K121797 | Class II | Active |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
Sources (2)
- FDA 510(k) K121797 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 28, 2026