# K042472: BD Directigen EZ Flu a + B

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: Jul 7, 2005 after 300 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: 1 generation back to K031565 (2003). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031565: Xpect Influenza a/B, Remel, Inc. (2003) Summary page 2.
- (no number) Cell Culture: named in the summary without a submission number
- (no number) Direct Fluorescent Antibody (DFA): named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K001364: BD Directigen Flu a+B, Bd Becton Dickinson Vacutainer Systems Preanalytic (2000). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K101461: BD Directigen EX Flu a+B (2010), 0 descendants of its own
- K101529: BD Directigen EZ Flu a+B Assay (2010), 0 descendants of its own

## Indications for use
The BD DirectigenTM 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 and throat swabs of symptomatic patients. The BD Directigen EZ Flu A+B test is a differentiated test, and therefore 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.

Source page: https://510kreport.com/device/K042472
Methodology: https://510kreport.com/methodology