510(k) · Cleared
ClearedInnovita Flu A/B Antigen Rapid Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovita (Tangshan) Biological Technology Co., Ltd. · PSZ Devices Detecting Influenza A, B, And C Virus Antigens
Cleared on Jul 3, 2025 as substantially equivalent to K191514 (Access Bio, Inc., 2020) after a 141-day review. Its family tree reaches back 14 generations to 1990.
- Decided
- Jul 3, 2025
- Review
- 141 days
- Class
- Class II
- Product code
- PSZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K902609 (1990). 16 ancestors in all. No later device cites it as a predicate yet.
- Root · 14 generations backK902609 Directigen Flu aBd Becton Dickinson Vacutainer Systems Preanalytic · 1990
- 10 generations between
- 3 generations backK160161 BD Veritor System for Rapid Detection of Flu A + B CLIA waived kitBecton, Dickinson & CO · 2016
- 2 generations backK180438 BD Veritor System for Rapid Detection of Flu A + B CLIA waived kitBd · 2018 · Recalled
- 1 generation backK191514 CareStart Flu A&B PlusAccess Bio, Inc. · 2020
- This deviceK250398 Innovita Flu A/B Antigen Rapid TestInnovita (Tangshan) Biological Technology Co., Ltd. · 2025
Show all 14 generations
- Root · 14 generations backK902609 Directigen Flu aBd Becton Dickinson Vacutainer Systems Preanalytic · 1990
- 13 generations backK981651 AB Flu OiaBiostar, Inc. · 1998
- 12 generations backK023556 Flu Oia a/B Test KitThermo Biostar, Inc. · 2003 · Recalled
- 11 generations backK031899 Quickvue Influenza a+B TestQuidel Corp. · 2003
- 10 generations backK053146 Quickvue Influenza a + B TestQuidel Corp. · 2005
- 9 generations backK092698 Quickvue Influenza a+B TestQuidel Corp. · 2009
- 8 generations backK112277 BD Veritor (TM) System for Rapid Detection of Flu a+BBecton, Dickinson and Company · 2011 · Recalled
- 7 generations backK132259 BD Veritor System for the Rapid Detection of Flu a+BBecton, Dickinson and Company · 2013
- 6 generations backK132692 BD Veritor System for the Rapid Detection of Flu a+BBecton, Dickinson and Company · 2013
- 5 generations backK151291 BD Veritor (TM) System for the Rapid Detection of Flu A+BBecton, Dickinson and Company · 2015
- 4 generations backK152870 BD Veritor System for the Rapid Detection of Flu A + B CLIA waived kitBecton, Dickinson and Co. · 2015
- 3 generations backK160161 BD Veritor System for Rapid Detection of Flu A + B CLIA waived kitBecton, Dickinson & CO · 2016
- 2 generations backK180438 BD Veritor System for Rapid Detection of Flu A + B CLIA waived kitBd · 2018 · Recalled
- 1 generation backK191514 CareStart Flu A&B PlusAccess Bio, Inc. · 2020
- This deviceK250398 Innovita Flu A/B Antigen Rapid TestInnovita (Tangshan) Biological Technology Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K902609 | Directigen Flu a | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1990 | — |
| −13 | K981651 | AB Flu Oia | Biostar, Inc. | 1998 | — |
| −12 | K023556 | Flu Oia a/B Test Kit | Thermo Biostar, Inc. | 2003 | 1 |
| −11 | K031899 | Quickvue Influenza a+B Test | Quidel Corp. | 2003 | — |
| −10 | K053146 | Quickvue Influenza a + B Test | Quidel Corp. | 2005 | — |
| −9 | K092698 | Quickvue Influenza a+B Test | Quidel Corp. | 2009 | — |
| −8 | K112277 | BD Veritor (TM) System for Rapid Detection of Flu a+B | Becton, Dickinson and Company | 2011 | 1 |
| −7 | K132259 | BD Veritor System for the Rapid Detection of Flu a+B | Becton, Dickinson and Company | 2013 | — |
| −6 | K132692 | BD Veritor System for the Rapid Detection of Flu a+B | Becton, Dickinson and Company | 2013 | — |
| −5 | K151291 | BD Veritor (TM) System for the Rapid Detection of Flu A+B | Becton, Dickinson and Company | 2015 | — |
| −4 | K152870 | BD Veritor System for the Rapid Detection of Flu A + B CLIA waived kit | Becton, Dickinson and Co. | 2015 | — |
| −3 | K160161 | BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit | Becton, Dickinson & CO | 2016 | — |
| −2 | K180438 | BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit | Bd | 2018 | 2 |
| −1 | K191514 | CareStart Flu A&B Plus | Access Bio, Inc. | 2020 | — |
| 0 (this device) | K250398 | Innovita Flu A/B Antigen Rapid Test | Innovita (Tangshan) Biological Technology Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 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 |
|---|---|---|---|
| * | K191514 | CareStart Flu A&B PlusSummary page 5…PSZ Microbiology Influenza Virus Antigen Detection Test System 6. Predicate Devices: K191514, CareStart Flu A&B Plus 7. Intended Use The Innovita Flu A/B Antigen Rapid Test is a rapid chromatographic immunoassay int… | 2020 |
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 35 years and passes through 10 companies; a new generation was cleared every 2.1 years on median.
- 3 of the 16 ancestors have a recall of any class.
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. 2025, 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 Innovita Flu A/B Antigen Rapid Test is a rapid chromatographic immunoassay intended for the qualitative detection and differentiation of influenza A and B viral nucleoprotein antigens directly from nasopharyngeal swabs from patients with signs and symptoms of respiratory infection. The test is intended for use as an aid in the differential diagnosis of acute influenza A and B viral infections. The test is not intended to detect influenza C antigens.…
Read the full statement (229 words)
The Innovita Flu A/B Antigen Rapid Test is a rapid chromatographic immunoassay intended for the qualitative detection and differentiation of influenza A and B viral nucleoprotein antigens directly from nasopharyngeal swabs from patients with signs and symptoms of respiratory infection.
The test is intended for use as an aid in the differential diagnosis of acute influenza A and B viral infections. The test is not intended to detect influenza C antigens. Negative test results are presumptive and should be confirmed by viral culture or an FDA-cleared influenza A and B molecular assay. Negative test results do not preclude influenza viral infection and should not be used as the sole basis for treatment or other patient management decisions.
Performance characteristics for influenza A were established during the December 2023, and July 2024 influenza season when influenza A/H1N1pdm09, influenza A/H3N2 and influenza B/Victoria viruses were the predominant influenza viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary.
If an infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250398 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250398: Innovita Flu A/B Antigen Rapid Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250398
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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