510(k) · Cleared
ClearedBD Directigen EX Flu a+B
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton, Dickinson and Company · PSZ Devices Detecting Influenza A, B, And C Virus Antigens
Cleared on Jun 24, 2010 as substantially equivalent to K063689 (Becton, Dickinson & CO, 2007) and 1 other predicate after a 29-day review. Its family tree reaches back 6 generations to 1990.
- Decided
- Jun 24, 2010
- Review
- 29 days
- Class
- Class II
- Product code
- PSZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K902609 (1990). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK902609 Directigen Flu aBd Becton Dickinson Vacutainer Systems Preanalytic · 1990
- 5 generations backK981651 AB Flu OiaBiostar, Inc. · 1998
- 4 generations backK023556 Flu Oia a/B Test KitThermo Biostar, Inc. · 2003 · Recalled
- 3 generations backK041049 Binaxnow Influenza a & B TestBinax, Inc. · 2004
- 2 generations backK053126 Binaxnow Influenza a & B TestBinax, Inc. · 2005
- 1 generation backK063689 BD Directigen EZ Flu a+B TestBecton, Dickinson & CO · 2007
- This deviceK101461 BD Directigen EX Flu a+BBecton, Dickinson and Company · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K902609 | Directigen Flu a | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1990 | — |
| −5 | K981651 | AB Flu Oia | Biostar, Inc. | 1998 | — |
| −4 | K023556 | Flu Oia a/B Test Kit | Thermo Biostar, Inc. | 2003 | 1 |
| −3 | K041049 | Binaxnow Influenza a & B Test | Binax, Inc. | 2004 | — |
| −2 | K053126 | Binaxnow Influenza a & B Test | Binax, Inc. | 2005 | — |
| −1 | K063689 | BD Directigen EZ Flu a+B Test | Becton, Dickinson & CO | 2007 | — |
| 0 (this device) | K101461 | BD Directigen EX Flu a+B | Becton, Dickinson and Company | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 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? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K063689 | BD Directigen EZ Flu a+B TestSummary page 1…Influenza virus serological reagents DEVICE CLASSIFICATION: 21 CFR 866.3330 PREDICATE DEVICES: BD Directigen Tm EZ Flu A+B test (K063689), (K042472) INTENDED USE: The BD Directigen T m EZ Flu A+B test is a rapid chromatographic im… | 2007 |
| * | K042472 | BD Directigen EZ Flu a + BSummary page 1…ents DEVICE CLASSIFICATION: 21 CFR 866.3330 PREDICATE DEVICES: BD Directigen Tm EZ Flu A+B test (K063689), (K042472) INTENDED USE: The BD Directigen T m EZ Flu A+B test is a rapid chromatographic immunoassay for the direct and qualitative dete… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 20 years and passes through 6 companies; a new generation was cleared every 3.3 years on median.
- 1 of the 12 ancestors has a recall of any class.
- 1 other device also cites its predicate K063689.
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. 2010, this device’s year, is highlighted.
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 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…
Read the full statement (156 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101461 · printed Nov 3, 2026
Cite this page
510(k) Report. “K101461: BD Directigen EX Flu a+B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K101461
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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