510(k) · Cleared
ClearedAlere BinaxNOW Influenza A & B Card 2, Alere Reader
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alere Scarborough, Inc. · PSZ Devices Detecting Influenza A, B, And C Virus Antigens
Cleared on Aug 8, 2018 as substantially equivalent to K173502 (Alere Scarborough, Inc., 2017) after a 28-day review. Its family tree reaches back 14 generations to 1990.
- Decided
- Aug 8, 2018
- Review
- 28 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 backK162642 Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW…Alere Scarborough, Inc. · 2017
- 1 generation backK173502 Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW…Alere Scarborough, Inc. · 2017
- This deviceK181853 Alere BinaxNOW Influenza A & B Card 2, Alere ReaderAlere Scarborough, Inc. · 2018
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 backK162642 Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW…Alere Scarborough, Inc. · 2017
- 1 generation backK173502 Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW…Alere Scarborough, Inc. · 2017
- This deviceK181853 Alere BinaxNOW Influenza A & B Card 2, Alere ReaderAlere Scarborough, Inc. · 2018
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 | K162642 | Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza… | Alere Scarborough, Inc. | 2017 | — |
| −1 | K173502 | Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza… | Alere Scarborough, Inc. | 2017 | — |
| 0 (this device) | K181853 | Alere BinaxNOW Influenza A & B Card 2, Alere Reader | Alere Scarborough, Inc. | 2018 | — |
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 |
|---|---|---|---|
| * | K173502 | Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card…Summary page 4…tem (per 21 CFR 866.3328) CLASSIFICATION Class II PRODUCT CODE PSZ PANEL Microbiology (83) PREDICATE DEVICE Alere BinaxNOW® Influenza A & B Card 2 and Alere™ Reader, K173502 Alere BinaxNOW® Influenza A & B Card 2 with Alere™ Reader Page 1 of 4 Special 510(k) Notification - C… | 2017 |
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 28 years and passes through 8 companies; a new generation was cleared every 1.7 years on median.
- 2 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. 2018, 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 Alere BinaxNOW Influenza A & B Card 2 is an in vitro immunochromatographic assay for the qualitative detection of influenza A and B nucleoprotein antigens in nasopharyngeal (NP) swab and nasal swab specimens. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. Negative test results are presumptive and should be confirmed by cell culture or an FDA-cleared influenza A and B molecular assay. Negative test…
Read the full statement (217 words)
The Alere BinaxNOW Influenza A & B Card 2 is an in vitro immunochromatographic assay for the qualitative detection
of influenza A and B nucleoprotein antigens in nasopharyngeal (NP) swab and nasal swab specimens. It is intended to aid
in the rapid differential diagnosis of influenza A and B viral infections. Negative test results are presumptive and should be
confirmed by cell 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.
Alere BinaxNOW Influenza A & B Card 2 must be read by the Alere Reader.
Performance characteristics for influenza A were established during the 2015-2016 influenza season when influenza
A/H3N2 and A/H1N1 pandemic were the predominant influenza A viruses in circulation. When other influenza A viruses
are emerging, performance characteristics may vary.
If 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/K181853 · printed Nov 5, 2026
Cite this page
510(k) Report. “K181853: Alere BinaxNOW Influenza A & B Card 2, Alere Reader.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K181853
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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