510(k) Report

FDA applicant

Alere Scarborough, Inc.

Scarborough, ME17 decisions2012–20194 recalls

FDA records 17 decisions for Alere Scarborough, Inc. (Scarborough, ME) from 2012 to 2019: 16 510(k) clearances and 1 De Novo grant. Most are in product codes OCC (Respiratory Virus Panel Nucleic Acid Assay…) and PSZ (Devices Detecting Influenza A, B, And C Virus…). Since 2016 its 510(k)s took a median of 37 days from receipt to decision, against 113 for FDA’s reviews in the same codes and years. Its devices cite 20 predicates, 11 of them its own earlier devices. 4 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.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2019

2012: 12014: 22015: 32016: 32017: 32018: 32019: 2
2012high 3 (2015) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

1in 2026

2023: 12025: 22026 (partial year): 1
2012high 2 (2025) · low 0 (2012)2026

Class I Class II/III not classified

FIG. 1 — Alere Scarborough, Inc. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Alere Scarborough, 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?

  • OCCRespiratory Virus Panel Nucleic Acid Assay System5decisions
  • PSZDevices Detecting Influenza A, B, And C Virus Antigens3decisions
  • MYISystem, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies2decisions
  • PGXGroups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System2decisions
  • OAMImmunoassay, Insulin-Like Growth Factor Binding Protein-11decision
  • JBFGlucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening1decision

Also: OOI (1), OZE (1), QFA (1).

How long do its 510(k) reviews take?

Since 2016, its 8 510(k)s took a median of 37 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 113 days; 5 of its 8 were faster than that.

Whose devices does it build on?

Its devices cite 20 predicates; 11 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 15 times; 11 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.

  • K141757Alere I Strep aAlere Scarborough, Inc. · 20152cite it
  • K171792Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab KitAlere Scarborough, Inc. · 20172cite it
  • K173932Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2Alere Scarborough, Inc. · 20182cite it
  • K163266Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i InstrumentAlere Scarborough, Inc. · 20162cite it
  • K161375Alere i RSV, Alere i Instrument, Alere i RSV Control Swab KitAlere Scarborough, Inc. · 20161cites it
  • K151690Alere i Instrument, Alere i Influenza A & B, Alere i Strep AAlere Scarborough, Inc. · 20151cites it

What has FDA decided for it lately?

  • DEN180014WOUNDCHEK Bacterial StatusAlere Scarborough, Inc. · 2019
  • K190204ID NOW Influenza A & B 2Alere Scarborough, Inc. · 2019
  • K181853Alere BinaxNOW Influenza A & B Card 2, Alere ReaderAlere Scarborough, Inc. · 2018
  • K173653Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab KitAlere Scarborough, Inc. · 2018
  • K173932Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2Alere Scarborough, Inc. · 2018
  • K173502Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab KitAlere Scarborough, Inc. · 2017
  • K171792Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab KitAlere Scarborough, Inc. · 20171 recall
  • K162642Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab KitAlere Scarborough, Inc. · 2017

All 17 as Alere Scarborough, Inc. →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K171792Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Software Version…Feb 9, 2026Class II
  • K161375Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000…Mar 4, 2025Class II
  • K161375Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000…Mar 4, 2025Class II
  • K123986Actim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for rupture of…Nov 23, 2023Class II

Other applicant names beginning “Alere”

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

Alere Scarborough, Inc D/B/A Binax, Inc. 4Alere 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