# K101461: BD Directigen EX Flu a+B

- Pathway: 510(k) (Special)
- Applicant: Becton, Dickinson and Company
- Decided: Jun 24, 2010 after 29 days
- Product code: PSZ (Devices Detecting Influenza A, B, And C Virus Antigens)
- Device class: 2
- Regulation: 21 CFR 866.3328
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K902609 (1990). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063689: BD Directigen EZ Flu a+B Test, Becton, Dickinson & CO (2007) Summary page 1.
- K042472: BD Directigen EZ Flu a + B, Becton, Dickinson & CO (2005) Summary page 1.

## Indications for use
The BD Directigen EZ Flu A+B test is a rapid chromatographic immunoassay for the direct and qualitative detection of influenza A and B viral antigens from nasopharyngeal washes/aspirates, nasopharyngeal swabs and throat swabs of symptomatic patients. The Directigen EZ Flu A+B test is a differentiated test, such that influenza A viral antigens can be distinguished from influenza B viral antigens from a single processed sample using a single device. The test is to be used as an aid in the diagnosis of influenza A and B viral infections. All negative test results should be confirmed by cell culture because negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions. Performance characteristics for Influenza B using nasopharyngeal swabs (NPS) were established primarily with retrospective, frozen specimens. Users may wish to establish the sensitivity of this test for Influenza B using fresh nasopharyngeal swab specimens.

Source page: https://510kreport.com/device/K101461
Methodology: https://510kreport.com/methodology