510(k) Report

510(k) · Cleared

Cleared

Alere Binaxnow Influenza a & B Card

K133411510(k) SpecialCleared Dec 5, 201328-day reviewClass I21 CFR 866.3330

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

Alere Scarborough, Inc D/B/A Binax, Inc. · GNX Antigens, Cf (Including Cf Control), Influenza Virus A, B, C

Cleared on Dec 5, 2013 as substantially equivalent to K092223 (Binax, Inc., 2009) after a 28-day review. Its family tree reaches back 3 generations to 2000.

Decided
Dec 5, 2013
Review
28 days
Class
Class I
Product code
GNX
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K001364 (2000). No later device cites it as a predicate yet.

K001364 · BD Directigen Flu a+B · Bd Becton Dickinson Vacutainer Systems Preanalytic · 2000K062109 · Binaxnow Influenza a & B Test · Binax, Inc. · 2006 · recalledK092223 · Modification to: Binaxnow Influenza a & B Test · Binax, Inc. · 20092000200520102015
K092223 · Modification to: Binaxnow Influenza a & B Test · Binax, Inc. · 2009K062109 · Binaxnow Influenza a & B Test · Binax, Inc. · 2006 · recalledK001364 · BD Directigen Flu a+B · Bd Becton Dickinson Vacutainer Systems Preanalytic · 20000
  1. Root · 3 generations backK001364 BD Directigen Flu a+BBd Becton Dickinson Vacutainer Systems Preanalytic · 2000
  2. 2 generations backK062109 Binaxnow Influenza a & B TestBinax, Inc. · 2006 · Recalled
  3. 1 generation backK092223 Modification to: Binaxnow Influenza a & B TestBinax, Inc. · 2009
  4. This deviceK133411 Alere Binaxnow Influenza a & B CardAlere Scarborough, Inc D/B/A Binax, Inc. · 2013
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K001364BD Directigen Flu a+BBd Becton Dickinson Vacutainer Systems Preanalytic2000—
−2K062109Binaxnow Influenza a & B TestBinax, Inc.20062
−1K092223Modification to: Binaxnow Influenza a & B TestBinax, Inc.2009—
0 (this device)K133411Alere Binaxnow Influenza a & B CardAlere Scarborough, Inc D/B/A Binax, Inc.2013—
FIG. 1 — Lineage of K133411, 2000–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 GNX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K092223Modification to: Binaxnow Influenza a & B Test
Summary page 1
…za virus serological reagents (per 21 CFR 866.3330) CLASSIFICATION Class I PRODUCT CODE GNX PANEL Microbiology PREDICATE DEVICE Alere BinaxN0WQ Influenza A & B Card, K092223 DEVICE DESCRIPTION The Alere BinaxNOW® Influenza A & B Card is an immunochromatographic membrane assay that uses highly sensitiv…
Binax, Inc.2009—

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 3 companies; a new generation was cleared every 4.3 years on median.
  • 1 of the 3 ancestors has a recall of any class.

How does its category compare?

All GNX devices

GNX Antigens, Cf (Including Cf Control), Influenza Virus A, B, C: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · GNX

6in 2013

2012: 12013: 6
2007high 6 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GNX

27in 2013

2013: 27 days median
2007high 27 (2013)2026

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

Recalls per year · GNX

1in 2012

2007: 42008: 12012: 1
2007high 4 (2007) · low 0 (2009)2026

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

Adverse event reports per year · GNX

93in 2025

2010: 12011: 22012: 42014: 32015: 32017: 12018: 22021: 362022: 322023: 612024: 32025: 93
2007high 93 (2025) · low 0 (2007)2025

MAUDE reports naming product code GNX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—40
20080—10
20090—00
20100—01
20110—02
20121—14
201362700
20140—03
20150—03
20160—00
20170—01
20180—02
20190—00
20200—00
20210—036
20220—032
20230—061
20240—03
20250—093
20260—0—

What is it indicated for?

The Alere BinaxNOW® Influenza A & B Card 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 test results are presumptive and should be confirmed by cell culture or an FDA-cleared influenza A and B molecular…

Read the full statement (124 words)

The Alere BinaxNOW® Influenza A & B Card 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 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.

Caution: Assay sensitivity for nasal wash/aspirate samples was determined primarily using archived specimens. Users may wish to establish the sensitivity of these specimens on fresh samples.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Alere Scarborough, Inc D/B/A Binax, Inc.

4 FDA decisions under this applicant name. See the company

  • K141520Alere I Influenza a & BAlere Scarborough, Inc D/B/A Binax, Inc. · 20143 recalls
  • K133637Alere Influenza a & B TestAlere Scarborough, Inc D/B/A Binax, Inc. · 2013
  • K103610Clearview Exact II Influenza a & B TestAlere Scarborough, Inc D/B/A Binax, Inc. · 2011

Recent decisions in GNX

The GNX category page

  • K132352Sas Flualert a & B, Sas Influenza a TestSa Scientific, Ltd. · 2013
  • K131804Remel Xpect Flu a&BRemel, Inc. · 2013
  • K131599Quick Vue InfluenzaQuidel Corporation · 2013
  • K131606Sofia Influenza a+B FiaQuidel Corp. · 2013
  • K131619Quickvue Influenza a+BQuidel Corp. · 2013

https://510kreport.com/device/K133411 · printed Nov 6, 2026

Cite this page

510(k) Report. “K133411: Alere Binaxnow Influenza a & B Card.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133411

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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