510(k) · Cleared
Recalled · 2008Flu Oia a/B Test Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thermo Biostar, Inc. · PSZ Devices Detecting Influenza A, B, And C Virus Antigens
Cleared on Mar 27, 2003 as substantially equivalent to K981651 (Biostar, Inc., 1998) after a 155-day review. Its family tree reaches back 2 generations to 1990. 40 later devices descend from it. It has been recalled once.
- Decided
- Mar 27, 2003
- Review
- 155 days
- Class
- Class II
- Product code
- PSZ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K902609 (1990). 40 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK902609 Directigen Flu aBd Becton Dickinson Vacutainer Systems Preanalytic · 1990
- 1 generation backK981651 AB Flu OiaBiostar, Inc. · 1998
- This deviceK023556 Flu Oia a/B Test KitThermo Biostar, Inc. · 2003
- Descendant · cites it directly · 34 of its ownK031899 Quickvue Influenza a+B TestQuidel Corp. · 2003
- Descendant · 2 generations on · 27 of its ownK053146 Quickvue Influenza a + B TestQuidel Corp. · 2005
- Descendant · 2 generations on · 24 of its ownK092698 Quickvue Influenza a+B TestQuidel Corp. · 2009
- Descendant · 3 generations on · 20 of its ownK112277 BD Veritor (TM) System for Rapid Detection of Flu a+BBecton, Dickinson and Company · 2011 · Recalled
- Descendant · 4 generations on · 19 of its ownK132259 BD Veritor System for the Rapid Detection of Flu a+BBecton, Dickinson and Company · 2013
Showing 5 of 40 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 40 · See all- K031899Quickvue Influenza a+B TestQuidel Corp. · 2003 · cites it directly34descendants
- K053146Quickvue Influenza a + B TestQuidel Corp. · 2005 · 2 generations on27descendants
- K092698Quickvue Influenza a+B TestQuidel Corp. · 2009 · 2 generations on24descendants
- K112277BD Veritor (TM) System for Rapid Detection of Flu a+BBecton, Dickinson and Company · 2011 · 3 generations on20descendants
- K132259BD Veritor System for the Rapid Detection of Flu a+BBecton, Dickinson and Company · 2013 · 4 generations on19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K902609 | Directigen Flu a | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1990 | — |
| −1 | K981651 | AB Flu Oia | Biostar, Inc. | 1998 | — |
| 0 (this device) | K023556 | Flu Oia a/B Test Kit | Thermo Biostar, Inc. | 2003 | — |
| +1 | K031899 | Quickvue Influenza a+B Test | Quidel Corp. | 2003 | — |
| +2 | K053146 | Quickvue Influenza a + B Test | Quidel Corp. | 2005 | — |
| +2 | K092698 | Quickvue Influenza a+B Test | Quidel Corp. | 2009 | — |
| +3 | K112277 | BD Veritor (TM) System for Rapid Detection of Flu a+B | Becton, Dickinson and Company | 2011 | 1 |
| +4 | K132259 | BD Veritor System for the Rapid Detection of Flu a+B | Becton, Dickinson and Company | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 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 |
|---|---|---|---|
| * | K981651 | AB Flu OiaSummary page 1…I Manufacturer: Thermo BioStar 510(k) Number: K98165 1 Historical Reference Method: Viral Culture Intended use of device [$807.92(a)(5)]: T… | 1998 |
What descends from it? (40)
See all 403 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 2, 2008 | Not classified | Z-0212-2009 | Mixed-up of materials/components | Diagnostic kits for flu were distributed with incorrect components. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 8.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K031899 (Quidel Corp., 2003) has gone furthest, with 34 descendants of its own.
- 1 other device also cites its predicate K981651.
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 Thermo BioStarr" FLU OIA' A/B assay is an Optical ImmunoAssay test for the qualitative, rapid detection of influenza A and B viral antigens (nucleoproteins) extracted from nasal aspirate, nasopharyngeal swab, throat swab, and sputum specimens. This test is intended for in vitro diagnostic use to aid in the differential diagnosis of influenza A and B viral infections. The FLU OIA A/B test is not intended for detection of influenza C. Negative test results should be confirmed by cell culture.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023556 · printed Nov 4, 2026
Cite this page
510(k) Report. “K023556: Flu Oia a/B Test Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023556
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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