Identifiers
- 510(k) Number
- K101461 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 Directigen Ex Flu A+B is a rapid chromatographic immunoassay designed for the direct and qualitative detection of influenza A and B viral antigens. It is classified under Devices Detecting Influenza A, B, and C Virus Antigens (product code PSZ) and operates as a point-of-care diagnostic tool.
This device is intended for use with nasopharyngeal washes/aspirates, nasopharyngeal swabs, and throat swabs from symptomatic patients. Supplied as a single-use diagnostic kit, it requires no special storage conditions beyond standard laboratory environments and is regulated under FDA 510(k) clearance (K101461) with a classification of Class II under Special Controls. The device is not MRI-compatible and is intended for in vitro diagnostic use.
Frequently asked questions
What types of samples can be tested using the BD Directigen Ex Flu A+B, and how are they collected?
The BD Directigen Ex Flu A+B is designed to detect influenza A and B viral antigens in nasopharyngeal washes/aspirates, nasopharyngeal swabs, and throat swabs. These samples are collected from symptomatic patients to aid in rapid point-of-care diagnosis, ensuring timely treatment decisions.
Is the BD Directigen Ex Flu A+B intended for single-use or reusable applications, and what storage conditions are required?
The BD Directigen Ex Flu A+B is supplied as a single-use diagnostic kit, meaning each test is intended for one use only. No special storage conditions are required beyond standard laboratory environments, making it convenient for use in various clinical settings.
How is the regulatory status of the BD Directigen Ex Flu A+B determined, and what classification does it hold?
The BD Directigen Ex Flu A+B holds FDA 510(k) clearance (K101461) and is classified under Class II with Special Controls. This classification is based on its role as a point-of-care diagnostic tool for detecting influenza A and B viral antigens, ensuring it meets stringent regulatory standards for safety and effectiveness.
Can this device be used in environments where MRI machines are present, and why?
No, the BD Directigen Ex Flu A+B is explicitly stated as not MRI-compatible. This means it should not be used or stored in areas where MRI machines operate, as exposure to magnetic fields could potentially affect its performance or integrity.
What medical specialty is primarily associated with the use of the BD Directigen Ex Flu A+B, and why?
The primary medical specialty associated with the BD Directigen Ex Flu A+B is Microbiology. This is because the device is specifically designed for the rapid detection of influenza A and B viral antigens, which falls under the purview of microbiological diagnostics to identify infectious agents in clinical samples.
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: PDF Submitted By: Becton, Dickinson and Company Jn2 42, BD DIRECTIGEN EZ FLU A+B TEST (K063689) - FDA 510 (k), BD (company) - Wikipedia
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K101461 | Class II | Active |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
Sources (1)
- FDA 510(k) K101461 24 fields · synced Sep 18, 2026