510(k) · Cleared
ClearedAB Flu Oia
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biostar, Inc. · PSZ Devices Detecting Influenza A, B, And C Virus Antigens
Cleared on Nov 25, 1998 as substantially equivalent to K902609 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1990) after a 198-day review. Its family tree reaches back 1 generation to 1990. 45 later devices descend from it.
- Decided
- Nov 25, 1998
- Review
- 198 days
- Class
- Class II
- Product code
- PSZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K902609 (1990). 45 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK902609 Directigen Flu aBd Becton Dickinson Vacutainer Systems Preanalytic · 1990
- This deviceK981651 AB Flu OiaBiostar, Inc. · 1998
- Descendant · cites it directly · 40 of its ownK023556 Flu Oia a/B Test KitThermo Biostar, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 34 of its ownK031899 Quickvue Influenza a+B TestQuidel Corp. · 2003
- Descendant · 3 generations on · 27 of its ownK053146 Quickvue Influenza a + B TestQuidel Corp. · 2005
- Descendant · 3 generations on · 24 of its ownK092698 Quickvue Influenza a+B TestQuidel Corp. · 2009
- Descendant · 4 generations on · 20 of its ownK112277 BD Veritor (TM) System for Rapid Detection of Flu a+BBecton, Dickinson and Company · 2011 · Recalled
Showing 5 of 45 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 45 · See all- K023556Flu Oia a/B Test KitThermo Biostar, Inc. · 2003 · cites it directly40descendants
- K031899Quickvue Influenza a+B TestQuidel Corp. · 2003 · 2 generations on34descendants
- K053146Quickvue Influenza a + B TestQuidel Corp. · 2005 · 3 generations on27descendants
- K092698Quickvue Influenza a+B TestQuidel Corp. · 2009 · 3 generations on24descendants
- K112277BD Veritor (TM) System for Rapid Detection of Flu a+BBecton, Dickinson and Company · 2011 · 4 generations on20descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K902609 | Directigen Flu a | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1990 | — |
| 0 (this device) | K981651 | AB Flu Oia | Biostar, Inc. | 1998 | — |
| +1 | K023556 | Flu Oia a/B Test Kit | Thermo Biostar, Inc. | 2003 | 1 |
| +2 | K031899 | Quickvue Influenza a+B Test | Quidel Corp. | 2003 | — |
| +3 | K053146 | Quickvue Influenza a + B Test | Quidel Corp. | 2005 | — |
| +3 | K092698 | Quickvue Influenza a+B Test | Quidel Corp. | 2009 | — |
| +4 | K112277 | BD Veritor (TM) System for Rapid Detection of Flu a+B | Becton, Dickinson and Company | 2011 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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? (1)
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 |
|---|---|---|---|
| * | K902609 | Directigen Flu aSummary page 1…2(a)(3)]: e TRADE OR PROPRIETARY NAME: Directigen® Flu A ¢ REGULATORY CLASS: Class I e PRODUCT CODE: 83GNT e MANUFACTURER: Becton Dickinson® and Co. e 510(k) NUMBER: K902609 Note: Performance of the AB FLU OIA product was established versus cell culture. D. Description of device [§807.92(a)(4)}: Pri… | 1990 |
What descends from it? (45)
See all 452 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?
- Its one ancestor has no recall.
- Of its descendants, K023556 (Thermo Biostar, Inc., 2003) has gone furthest, with 40 descendants of its own.
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 BioStar® FLU OIA assay is an Optical InmunoAssay (OIA) test for the qualitative, rapid detection of influenza A and B viral antigen (nucleoprotein) from nasal aspirate, nasopharyngeal swabs, throat swabs, or sputum specimens. This test is intended for in vitro use to aid in influenza A and B viral infections. The FLU OIA is not intended to detect influenza C. Negative test results should be confirmed by culture [isolation].
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981651 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981651: AB Flu Oia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981651
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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