510(k) · Cleared
ClearedDirectigen Flu a
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bd Becton Dickinson Vacutainer Systems Preanalytic · GNT Antigens, Ha (Including Ha Control), Influenza Virus A, B, C
Cleared on Sep 10, 1990 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 46 later devices descend from it.
- Decided
- Sep 10, 1990
- Review
- 90 days
- Class
- Class I
- Product code
- GNT
- Recalls
- None
- Predicates
- 0
46 later devices descend from it, 1 citing it directly.
- This deviceK902609 Directigen Flu aBd Becton Dickinson Vacutainer Systems Preanalytic · 1990
- Descendant · cites it directly · 45 of its ownK981651 AB Flu OiaBiostar, Inc. · 1998
- Descendant · 2 generations on · 40 of its ownK023556 Flu Oia a/B Test KitThermo Biostar, Inc. · 2003 · Recalled
- Descendant · 3 generations on · 34 of its ownK031899 Quickvue Influenza a+B TestQuidel Corp. · 2003
- Descendant · 4 generations on · 27 of its ownK053146 Quickvue Influenza a + B TestQuidel Corp. · 2005
- Descendant · 4 generations on · 24 of its ownK092698 Quickvue Influenza a+B TestQuidel Corp. · 2009
Showing 5 of 46 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 46 · See all- K981651AB Flu OiaBiostar, Inc. · 1998 · cites it directly45descendants
- K023556Flu Oia a/B Test KitThermo Biostar, Inc. · 2003 · 2 generations on40descendants
- K031899Quickvue Influenza a+B TestQuidel Corp. · 2003 · 3 generations on34descendants
- K053146Quickvue Influenza a + B TestQuidel Corp. · 2005 · 4 generations on27descendants
- K092698Quickvue Influenza a+B TestQuidel Corp. · 2009 · 4 generations on24descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K902609 | Directigen Flu a | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1990 | — |
| +1 | K981651 | AB Flu Oia | Biostar, Inc. | 1998 | — |
| +2 | K023556 | Flu Oia a/B Test Kit | Thermo Biostar, Inc. | 2003 | 1 |
| +3 | K031899 | Quickvue Influenza a+B Test | Quidel Corp. | 2003 | — |
| +4 | K053146 | Quickvue Influenza a + B Test | Quidel Corp. | 2005 | — |
| +4 | K092698 | Quickvue Influenza a+B Test | Quidel Corp. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 6 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GNT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (46)
See all 461 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K981651 | AB Flu Oia | 1998 | 45 |
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?
- Of its descendants, K981651 (Biostar, Inc., 1998) has gone furthest, with 45 descendants of its own.
How does its category compare?
All GNT devicesGNT Antigens, Ha (Including Ha Control), Influenza Virus A, B, C: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GNT
FDA has decided no GNT device since 2007.
Median 510(k) review, days · GNT
Too few GNT 510(k)s in any year since 2007 to give a median.
Recalls per year · GNT
No recall names GNT since 2007.
Adverse event reports per year · GNT
No MAUDE report names GNT since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K902609 · printed Nov 4, 2026
Cite this page
510(k) Report. “K902609: Directigen Flu a.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K902609
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026