510(k) · Cleared
ClearedAlere Influenza a & B Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alere Scarborough, Inc D/B/A Binax, Inc. · PSZ Devices Detecting Influenza A, B, And C Virus Antigens
Cleared on Dec 18, 2013 as substantially equivalent to K103610 (Alere Scarborough, Inc D/B/A Binax, Inc., 2011) after a 41-day review. Its family tree reaches back 4 generations to 2000.
- Decided
- Dec 18, 2013
- Review
- 41 days
- Class
- Class II
- Product code
- PSZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K001364 (2000). No later device cites it as a predicate yet.
- Root · 4 generations backK001364 BD Directigen Flu a+BBd Becton Dickinson Vacutainer Systems Preanalytic · 2000
- 3 generations backK062109 Binaxnow Influenza a & B TestBinax, Inc. · 2006 · Recalled
- 2 generations backK092349 Clearview Exact II Influenza a & B TestInverness Medical, Inc. · 2010
- 1 generation backK103610 Clearview Exact II Influenza a & B TestAlere Scarborough, Inc D/B/A Binax, Inc. · 2011
- This deviceK133637 Alere Influenza a & B TestAlere Scarborough, Inc D/B/A Binax, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K001364 | BD Directigen Flu a+B | Bd Becton Dickinson Vacutainer Systems Preanalytic | 2000 | — |
| −3 | K062109 | Binaxnow Influenza a & B Test | Binax, Inc. | 2006 | 2 |
| −2 | K092349 | Clearview Exact II Influenza a & B Test | Inverness Medical, Inc. | 2010 | — |
| −1 | K103610 | Clearview Exact II Influenza a & B Test | Alere Scarborough, Inc D/B/A Binax, Inc. | 2011 | — |
| 0 (this device) | K133637 | Alere Influenza a & B Test | Alere Scarborough, Inc D/B/A Binax, Inc. | 2013 | — |
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 |
|---|---|---|---|
| * | K103610 | Clearview Exact II Influenza a & B TestSummary page 1…Influenza virus serological reagents (per 21 CFR 866.3330) CLASSIFICATION Class I PRODUCT CODE GNX PANEL Microbiology PREDICATE DEVICE Alere M Influenza A & B Test, K103610 Alere Influenza A & B Test Page 1 Special 510(k) Notifica… | 2011 |
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 13 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
- 1 of the 4 ancestors has 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. 2013, 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 Alerem Influenza A & B Test is an in vitro immunochromatographic assay for the qualitative detection of influenza A and B nucleoprotein antigens in nasal swab specimens collected from symptomatic patients. 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133637 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133637: Alere 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/K133637
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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