510(k) Report

FDA applicant

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

Scarborough, ME4 decisions2011–20143 recalls

FDA records 4 decisions for Alere Scarborough, Inc D/B/A Binax, Inc. (Scarborough, ME) from 2011 to 2014: 4 510(k) clearances. Most are in product codes PSZ (Devices Detecting Influenza A, B, And C Virus…) and GNX (Antigens, Cf (Including Cf Control), Influenza…). Its devices cite 4 predicates, 1 of them its own earlier devices. 3 recalls are linked to its devices.

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

FIG. A — Illustration, microbiology panel, where it files most

How often FDA has decided Alere Scarborough, Inc D/B/A Binax, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2011: 12013: 22014: 1
2011high 2 (2013) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

1in 2017

2015: 22017: 1
2011high 2 (2015) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Alere Scarborough, Inc D/B/A Binax, Inc. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Alere Scarborough, Inc D/B/A Binax, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • PSZDevices Detecting Influenza A, B, And C Virus Antigens2decisions
  • GNXAntigens, Cf (Including Cf Control), Influenza Virus A, B, C1decision
  • OCCRespiratory Virus Panel Nucleic Acid Assay System1decision

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K141520Alere I Influenza a & BAlere Scarborough, Inc D/B/A Binax, Inc. · 20143cite it
  • K103610Clearview Exact II Influenza a & B TestAlere Scarborough, Inc D/B/A Binax, Inc. · 20111cites it

What has FDA decided for it lately?

  • 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
  • K133411Alere Binaxnow Influenza a & B CardAlere Scarborough, Inc D/B/A Binax, Inc. · 2013
  • K103610Clearview Exact II Influenza a & B TestAlere Scarborough, Inc D/B/A Binax, Inc. · 2011

All 4 as Alere Scarborough, Inc D/B/A Binax, Inc. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K141520Influenza Transport Swab Packages, Reference #20171, One lot with 1010 packages (each…Jan 25, 2017Class II
  • K141520Alere i flu, Alere i, Alere Influenza A & B; Part Number (PN) 425-024 The Alere" i…Jun 26, 2015Class II
  • K141520Alere i Influenza A & B Product Usage: The Alere i Influenza A and B assay, performed on…Apr 22, 2015Class II

Other applicant names beginning “Alere”

FDA records each applicant name separately; these may or may not be the same firm.

Alere Scarborough, Inc. 17Alere Technologies AS 3Alere San Diego, Inc. 2Alere, San Diego, Dba Biosite INcorporated, Dba IN 1Alere, Inc. 1Alere San Diego, Inc (Formally Biosite Incorporate 1Alere San Diego Inc. Dba Biosite,Innovacon,Hemosen 1