510(k) · Cleared
Recalled · Class II · 2012Biosign Flu a+B
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Princeton BioMeditech Corp. · PSZ Devices Detecting Influenza A, B, And C Virus Antigens
Cleared on Nov 10, 2010 as substantially equivalent to K053146 (Quidel Corp., 2005) after a 693-day review. Its family tree reaches back 5 generations to 1990. It has been recalled 3 times.
- Decided
- Nov 10, 2010
- Review
- 693 days
- Class
- Class II
- Product code
- PSZ
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 5 generations to K902609 (1990). 7 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 deviceK083746 Biosign Flu a+BPrinceton BioMeditech Corp. · 2010
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) | K083746 | Biosign Flu a+B | Princeton BioMeditech Corp. | 2010 | — |
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 |
|---|---|---|---|
| * | K053146 | Quickvue Influenza a + B TestSummary page 1…Name: Influenza virus serological reagents (2I1CFR 866.3330) 4. Identification of legally marketed devices to which claims of equivalence are made: K053 146: QuickVue Influenza A+B Test by Quidel Corp. 5. Device Description: RioSign® Flu A±B is an immuno-chromatographic test for… | 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 9, 2012 | Class II | Z-2306-2012 | Nonconforming Material/Component | There have been reports of dual positive (Flu A + Flu B positive) results being encountered. |
| Mar 9, 2012 | Class II | Z-2308-2012 | Nonconforming Material/Component | There have been reports of dual positive (Flu A + Flu B positive) results being encountered. |
| Mar 9, 2012 | Class II | Z-2307-2012 | Nonconforming Material/Component | There have been reports of dual positive (Flu A + Flu B positive) results being encountered. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 5 companies; a new generation was cleared every 4.3 years on median.
- 1 of the 7 ancestors has a recall of any class.
- 5 other devices also cite its predicate K053146.
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. 2010, 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 BioSign®~ Flu A+B test is an in vitro rapid qualitative test that detects influenza type A and type B antigens directly from nasal swab, nasopharyngeal swab, nasopharyngeal aspirate/wash specimens of patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. A negative test result is presumptive and it is recommended these results be confirmed by viral culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083746 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083746: Biosign Flu a+B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083746
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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