510(k) · Cleared
ClearedBinaxnow Influenza a & B Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Binax, Inc. · PSZ Devices Detecting Influenza A, B, And C Virus Antigens
Cleared on Nov 30, 2005 as substantially equivalent to K041049 (Binax, Inc., 2004) and 2 other predicates after a 23-day review. Its family tree reaches back 4 generations to 1990. 3 later devices descend from it.
- Decided
- Nov 30, 2005
- Review
- 23 days
- Class
- Class II
- Product code
- PSZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K902609 (1990). 7 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK902609 Directigen Flu aBd Becton Dickinson Vacutainer Systems Preanalytic · 1990
- 3 generations backK981651 AB Flu OiaBiostar, Inc. · 1998
- 2 generations backK023556 Flu Oia a/B Test KitThermo Biostar, Inc. · 2003 · Recalled
- 1 generation backK041049 Binaxnow Influenza a & B TestBinax, Inc. · 2004
- This deviceK053126 Binaxnow Influenza a & B TestBinax, Inc. · 2005
- Descendant · cites it directly · 2 of its ownK063689 BD Directigen EZ Flu a+B TestBecton, Dickinson & CO · 2007
- Descendant · 2 generations on · 0 of its ownK101461 BD Directigen EX Flu a+BBecton, Dickinson and Company · 2010
- Descendant · 2 generations on · 0 of its ownK101529 BD Directigen EZ Flu a+B AssayBecton, Dickinson & CO · 2010
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K902609 | Directigen Flu a | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1990 | — |
| −3 | K981651 | AB Flu Oia | Biostar, Inc. | 1998 | — |
| −2 | K023556 | Flu Oia a/B Test Kit | Thermo Biostar, Inc. | 2003 | 1 |
| −1 | K041049 | Binaxnow Influenza a & B Test | Binax, Inc. | 2004 | — |
| 0 (this device) | K053126 | Binaxnow Influenza a & B Test | Binax, Inc. | 2005 | — |
| +1 | K063689 | BD Directigen EZ Flu a+B Test | Becton, Dickinson & CO | 2007 | — |
| +2 | K101461 | BD Directigen EX Flu a+B | Becton, Dickinson and Company | 2010 | — |
| +2 | K101529 | BD Directigen EZ Flu a+B Assay | Becton, Dickinson & CO | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2010 | 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 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? (3)
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 |
|---|---|---|---|
| * | K041049 | Binaxnow Influenza a & B TestSummary page 1…The purpose of this 510(k) submission is to expand the Analytical Reactivity claims of the currently 510(k) cleared BinaxNOW® Influenza A & B Test (510(k) #K041049). SUBMITTER Binax, Inc. 10 Southgate Road Scarborough, Maine 04074… | 2004 |
| * | K021649 | Binax Now Flu a Test (27 Test), Binax Now Nasopharyngeal Swab Specimen Accesory PackSummary page 1…uenza Virus A, B, C (per 21 CFR 866.3330) PREDICATE DEVICES Binax NOW® Influenza A & B Test; K041049 Binax NOW® Flu A Test; K021649 Binax NOW® Flu B Test; K021646 DEVICE DESCRIPTION: The BinaxNOW® Influenza A & B Te… | 2002 |
| * | K021646 | Binax Now Flu B Test (27 Test), Binax Now Nasopharyngeal Swab Specimen Accesory PackSummary page 1…PREDICATE DEVICES Binax NOW® Influenza A & B Test; K041049 Binax NOW® Flu A Test; K021649 Binax NOW® Flu B Test; K021646 DEVICE DESCRIPTION: The BinaxNOW® Influenza A & B Test is an immunochromatographic membrane assay… | 2002 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063689 | BD Directigen EZ Flu a+B Test | 2007 | 2 |
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 15 years and passes through 4 companies; a new generation was cleared every 4.3 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K063689 (Becton, Dickinson & CO, 2007) has gone furthest, with 2 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 BinaxNOW® Influenza A & B Test is an in vitro immunochromatographic assay for the qualitative detection of influenza A and B nucleoprotein antigens in nasopharyngeal (NP) swab and nasal wash/aspirate specimens. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. Negative test results should be confirmed by culture.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053126 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053126: Binaxnow Influenza a & B Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053126
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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