510(k) · Cleared

Recalled · 2007

Binaxnow Influenza a & B Test

K062109510(k) TraditionalCleared Nov 9, 2006108-day reviewClass II21 CFR 866.3328Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Binax, Inc. · PSZ Devices Detecting Influenza A, B, And C Virus Antigens

Cleared on Nov 9, 2006 as substantially equivalent to K001364 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 2000) after a 108-day review. Its family tree reaches back 1 generation to 2000. 8 later devices descend from it. It has been recalled 2 times.

Decided: Nov 9, 2006
Review: 108 days
Class: Class II
Product code: PSZ
Recalls: 2
Predicates: 1

Its longest line of descent runs back 1 generation to K001364 (2000). 8 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK001364 BD Directigen Flu a+BBd Becton Dickinson Vacutainer Systems Preanalytic · 2000
This deviceK062109 Binaxnow Influenza a & B TestBinax, Inc. · 2006
Descendant · cites it directly · 2 of its ownK092349 Clearview Exact II Influenza a & B TestInverness Medical, Inc. · 2010
Descendant · 2 generations on · 1 of its ownK103610 Clearview Exact II Influenza a & B TestAlere Scarborough, Inc D/B/A Binax, Inc. · 2011
Descendant · cites it directly · 1 of its ownK092223 Modification to: Binaxnow Influenza a & B TestBinax, Inc. · 2009
Descendant · cites it directly · 1 of its ownK071591 Ramp Influenza a/B AssayResponse Biomedical Corp. · 2008
Descendant · 3 generations on · 0 of its ownK133637 Alere Influenza a & B TestAlere Scarborough, Inc D/B/A Binax, Inc. · 2013

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2007high 2 (2009) · low 0 (2012)2026

Most influential descendants

Showing 5 of 8 · See all

K092349Clearview Exact II Influenza a & B TestInverness Medical, Inc. · 2010 · cites it directly2descendants
K103610Clearview Exact II Influenza a & B TestAlere Scarborough, Inc D/B/A Binax, Inc. · 2011 · 2 generations on1descendant
K092223Modification to: Binaxnow Influenza a & B TestBinax, Inc. · 2009 · cites it directly1descendant
K071591Ramp Influenza a/B AssayResponse Biomedical Corp. · 2008 · cites it directly1descendant
K133637Alere Influenza a & B TestAlere Scarborough, Inc D/B/A Binax, Inc. · 2013 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K001364	BD Directigen Flu a+B	Bd Becton Dickinson Vacutainer Systems Preanalytic	2000	—
0 (this device)	K062109	Binaxnow Influenza a & B Test	Binax, Inc.	2006	—
+1	K092349	Clearview Exact II Influenza a & B Test	Inverness Medical, Inc.	2010	—
+2	K103610	Clearview Exact II Influenza a & B Test	Alere Scarborough, Inc D/B/A Binax, Inc.	2011	—
+1	K092223	Modification to: Binaxnow Influenza a & B Test	Binax, Inc.	2009	—
+1	K071591	Ramp Influenza a/B Assay	Response Biomedical Corp.	2008	—
+3	K133637	Alere Influenza a & B Test	Alere Scarborough, Inc D/B/A Binax, Inc.	2013	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2008	1	0
2009	2	0
2010	1	0
2011	1	0
2013	2	0

FIG. 1 — Lineage of K062109, 2000–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K001364	BD Directigen Flu a+B Summary page 1 …510(k) #K041049). To establish substantial equivalence to the predicate, the BinaxNOW® Influenza A & B Test was compared to the BD Directigen TM Flu A+B Test (510(k) # K001 364). SUBMITTER Binax, Inc., d/b/a Inverness Medical Professional Diagnostics 10 Southgate Road Scarborough, Maine 04074 (207) 730-5…	Bd Becton Dickinson Vacutainer Systems Preanalytic	2000	—

Also cleared against K001364: 3 other devices →

What descends from it? (8)

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K092349	Clearview Exact II Influenza a & B Test	Inverness Medical, Inc.	2010	2
K092223	Modification to: Binaxnow Influenza a & B Test	Binax, Inc.	2009	1
K071591	Ramp Influenza a/B Assay	Response Biomedical Corp.	2008	1
K071657	Tru Flu	Meridian Bioscience, Inc.	2007	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Mar 28, 2007	Not classified	Z-0822-2007	Other	Tip of the foam swab could detach from the shaft causing injury to the patient.
Mar 28, 2007	Not classified	Z-0823-2007	Other	Tip of the foam swab could detach from the shaft causing injury to the patient.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K092349 (Inverness Medical, Inc., 2010) has gone furthest, with 2 descendants of its own.
3 other devices also cite its predicate K001364.

How does its category compare?

All PSZ devices

PSZ 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

2007high 8 (2013) · low 0 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PSZ

28in 2018

2007high 200 (2017) · low 20 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · PSZ

1in 2022

2007high 1 (2020) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · PSZ

60in 2025

2007high 60 (2025) · low 0 (2007)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, nasal swab, and nasal wash/aspirate specimens. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decision.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K062109 · printed Nov 6, 2026

Cite this page

510(k) Report. “K062109: 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/K062109

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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