510(k) · Cleared
ClearedAvc a/H5N1 Flu Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arbor Vita Corportation · OMS Novel Influenza A Virus, A/H5 Ns1 Protein
Cleared on Apr 8, 2009 as substantially equivalent to K080570 (Centers for Disease Control and Prevention, 2008) and 1 other predicate after a 152-day review. Its family tree reaches back 5 generations to 1990.
- Decided
- Apr 8, 2009
- Review
- 152 days
- Class
- Class II
- Product code
- OMS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K902609 (1990). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK902609 Directigen Flu aBd Becton Dickinson Vacutainer Systems Preanalytic · 1990
- 4 generations backK981651 AB Flu OiaBiostar, Inc. · 1998
- 3 generations backK023556 Flu Oia a/B Test KitThermo Biostar, Inc. · 2003 · Recalled
- 2 generations backK031899 Quickvue Influenza a+B TestQuidel Corp. · 2003
- 1 generation backK053146 Quickvue Influenza a + B TestQuidel Corp. · 2005
- This deviceK083278 Avc a/H5N1 Flu TestArbor Vita Corportation · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K902609 | Directigen Flu a | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1990 | — |
| −4 | K981651 | AB Flu Oia | Biostar, Inc. | 1998 | — |
| −3 | K023556 | Flu Oia a/B Test Kit | Thermo Biostar, Inc. | 2003 | 1 |
| −2 | K031899 | Quickvue Influenza a+B Test | Quidel Corp. | 2003 | — |
| −1 | K053146 | Quickvue Influenza a + B Test | Quidel Corp. | 2005 | — |
| 0 (this device) | K083278 | Avc a/H5N1 Flu Test | Arbor Vita Corportation | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 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 OMS? 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? (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 |
|---|---|---|---|
| * | K080570 | CDC Human Influenza Virus Real-Time RT- PCR Detection and Characterization PanelSummary page 2…-PCR Detection and Characterization Panel (Centers for Disease Control and Prevention, Atlanta, GA) based on intended use and cleared under K080570, and the QuickVue Influenza A+B Test (Quidel Corporation, San Diego, CA), based on technological ch… | 2008 |
| * | K053146 | Quickvue Influenza a + B TestSummary page 2…K080570, and the QuickVue Influenza A+B Test (Quidel Corporation, San Diego, CA), based on technological characteristics and cleared under K053146. O. ........ H ills:j . . . . Section 7: 510(k) Summary… | 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 19 years and passes through 5 companies; a new generation was cleared every 3.3 years on median.
- 1 of the 10 ancestors has a recall of any class.
- 7 other devices also cite its predicate K080570.
How does its category compare?
All OMS devicesOMS Novel Influenza A Virus, A/H5 Ns1 Protein: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · OMS
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · OMS
Too few OMS 510(k)s in any year since 2007 to give a median.
Recalls per year · OMS
No recall names OMS since 2007.
Adverse event reports per year · OMS
No MAUDE report names OMS 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 | 1 | — | 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 | — |
What is it indicated for?
The AVantage TM A/H5N1 Flu Test is intended for the in vitro qualitative detection of influenza A/H5N1 virus directly from symptomatic patient nasal or throat swab specimens or in viral cultures for the presumptive laboratory identification of influenza A/H5N1 virus. Results from testing with the AVantage TM A/H5N1 Flu Test should be used in conjunction with other laboratory testing and clinical and epidemiological risk factors for the presumptive…
Read the full statement (173 words)
The AVantage TM A/H5N1 Flu Test is intended for the in vitro qualitative detection of influenza A/H5N1 virus directly from symptomatic patient nasal or throat swab specimens or in viral cultures for the presumptive laboratory identification of influenza A/H5N1 virus.
Results from testing with the AVantage TM A/H5N1 Flu Test should be used in conjunction with other laboratory testing and clinical and epidemiological risk factors for the presumptive identification of patients infected with Influenza H5N1 virus. AVantage TM A/H5N1 Flu Test is intended as a Prescription Use device.
Testing should not be performed unless the patient meets the most current U.S. Department of Health and Human Services (DHHS) clinical and epidemiologic criteria for testing suspect A/H5 specimens. The definitive identification of influenza A/H5 either directly from patient specimens or from viral cultures requires additional laboratory testing, along with clinical and epidemiological assessment in consultation with national influenza surveillance experts.
Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions.
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/K083278 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083278: Avc a/H5N1 Flu Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083278
Report an extraction error
Are you the manufacturer?
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