510(k) · Cleared
ClearedBD Directigen EZ Flu a + B
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton, Dickinson & CO · PSZ Devices Detecting Influenza A, B, And C Virus Antigens
Cleared on Jul 7, 2005 as substantially equivalent to K031565 (Remel, Inc., 2003) after a 300-day review. Its family tree reaches back 1 generation to 2003. 2 later devices descend from it.
- Decided
- Jul 7, 2005
- Review
- 300 days
- Class
- Class II
- Product code
- PSZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K031565 (2003). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK031565 Xpect Influenza a/BRemel, Inc. · 2003
- This deviceK042472 BD Directigen EZ Flu a + BBecton, Dickinson & CO · 2005
- Descendant · cites it directly · 0 of its ownK101461 BD Directigen EX Flu a+BBecton, Dickinson and Company · 2010
- Descendant · cites it directly · 0 of its ownK101529 BD Directigen EZ Flu a+B AssayBecton, Dickinson & CO · 2010
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K031565 | Xpect Influenza a/B | Remel, Inc. | 2003 | — |
| 0 (this device) | K042472 | BD Directigen EZ Flu a + B | Becton, Dickinson & CO | 2005 | — |
| +1 | K101461 | BD Directigen EX Flu a+B | Becton, Dickinson and Company | 2010 | — |
| +1 | K101529 | BD Directigen EZ Flu a+B Assay | Becton, Dickinson & CO | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PSZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PSZ device
- #1 K252283 Nano-Check Influenza A+B Testscore 14.9 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K001364 | FDA’s K001364 is BD Directigen Flu a+B Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2000 |
| * | K031565 | Xpect Influenza a/BSummary page 2…Flu A+B test was compared to viral cell culture, direct fluorescent antibody (DFA) tests, the BD Directigen TM Flu A+B test (KOO] 364) and the Remel Xpect FLU A/I test (K031565). Although there are some differences between the BD DirectigenTM EZ Flu A+B test and the predicate devices, these differences do… | 2003 |
| * | — | Cell Culture Named without a submission number | |
| * | — | Direct Fluorescent Antibody (DFA) Named without a submission number |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All PSZ devicesPSZ Devices Detecting Influenza A, B, And C Virus Antigens: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · PSZ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PSZ
28in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PSZ
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PSZ
60in 2025
MAUDE reports naming product code PSZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 7 | 20 | 0 | 0 |
| 2010 | 5 | 29 | 0 | 0 |
| 2011 | 3 | 80 | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 8 | 28 | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 4 | 27 | 0 | 0 |
| 2016 | 3 | 29 | 0 | 0 |
| 2017 | 3 | 200 | 0 | 0 |
| 2018 | 5 | 28 | 0 | 1 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 2 | — | 1 | 5 |
| 2021 | 0 | — | 0 | 42 |
| 2022 | 0 | — | 1 | 10 |
| 2023 | 2 | — | 0 | 12 |
| 2024 | 0 | — | 0 | 16 |
| 2025 | 2 | — | 0 | 60 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042472 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042472: BD Directigen EZ Flu a + B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042472
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026