510(k) · Cleared
ClearedBinax Now Flu a Test (27 Test), Binax Now Nasopharyngeal Swab Specimen Accesory Pack
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 Sep 19, 2002 as substantially equivalent to K991633 (Quidel Corp., 1999) after a 122-day review. Its family tree reaches back 1 generation to 1999. 11 later devices descend from it.
- Decided
- Sep 19, 2002
- Review
- 122 days
- Class
- Class II
- Product code
- PSZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K991633 (1999). 11 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK991633 Quickvue Influenza a/B TestQuidel Corp. · 1999
- This deviceK021649 Binax Now Flu a Test (27 Test), Binax Now Nasopharyngeal Swab…Binax, Inc. · 2002
- Descendant · cites it directly · 4 of its ownK041049 Binaxnow Influenza a & B TestBinax, Inc. · 2004
- Descendant · cites it directly · 3 of its ownK053126 Binaxnow Influenza a & B TestBinax, Inc. · 2005
- Descendant · 2 generations on · 2 of its ownK063689 BD Directigen EZ Flu a+B TestBecton, Dickinson & CO · 2007
- Descendant · cites it directly · 2 of its ownK041439 Sas Influenza B TestSa Scientific, Inc. · 2004
- Descendant · cites it directly · 2 of its ownK041441 Sas Influenza a TestSa Scientific, Inc. · 2004
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K041049Binaxnow Influenza a & B TestBinax, Inc. · 2004 · cites it directly4descendants
- K053126Binaxnow Influenza a & B TestBinax, Inc. · 2005 · cites it directly3descendants
- K063689BD Directigen EZ Flu a+B TestBecton, Dickinson & CO · 2007 · 2 generations on2descendants
- K041439Sas Influenza B TestSa Scientific, Inc. · 2004 · cites it directly2descendants
- K041441Sas Influenza a TestSa Scientific, Inc. · 2004 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K991633 | Quickvue Influenza a/B Test | Quidel Corp. | 1999 | — |
| 0 (this device) | K021649 | Binax Now Flu a Test (27 Test), Binax Now Nasopharyngeal Swab Specimen… | Binax, Inc. | 2002 | — |
| +1 | K041049 | Binaxnow Influenza a & B Test | Binax, Inc. | 2004 | — |
| +1 | K053126 | Binaxnow Influenza a & B Test | Binax, Inc. | 2005 | — |
| +2 | K063689 | BD Directigen EZ Flu a+B Test | Becton, Dickinson & CO | 2007 | — |
| +1 | K041439 | Sas Influenza B Test | Sa Scientific, Inc. | 2004 | — |
| +1 | K041441 | Sas Influenza a Test | Sa Scientific, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K991633 | Quickvue Influenza a/B TestSummary page 1…B, C (per 21 CFR 866.3330) Predicate Device: Quidel QuickVue@ Influenza Test, 510 (k) number K991633 Device Description: The Binax NOW@ Flu A Test is an immunochromatographic membrane a… | 1999 |
What descends from it? (11)
See all 115 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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 Binax NOW@ Flu A Test is an in vitro rapid imunochromatographic assay for the qualitative detection of influenza A nucleoprotein antigen in nasal wash and nasopharyngeal swab specimens from symptomatic patients. It is intended to aid in the rapid diagnosis of influenza A infections. Negative test results should be confirmed by cell culture.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021649 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021649: Binax Now Flu a Test (27 Test), Binax Now Nasopharyngeal Swab Specimen Accesory Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021649
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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