510(k) Report

FDA applicant

Binax, Inc.

Portland, ME30 decisions1986–20106 recalls

FDA records 30 decisions for Binax, Inc. (Portland, ME) from 1986 to 2010: 30 510(k) clearances. Most are in product codes PSZ (Devices Detecting Influenza A, B, And C Virus…) and GTZ (Antisera, All Groups, Streptococcus Spp.). Its devices cite 25 predicates, 7 of them its own earlier devices. 6 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 Binax, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2010

2008: 12009: 42010: 2
2007high 4 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2024

2007: 32024: 1
2007high 3 (2007) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Binax, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like 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 Antigens6decisions
  • GTZAntisera, All Groups, Streptococcus Spp.6decisions
  • MJHLegionella, Spp., Elisa2decisions
  • LCPAssay, Glycosylated Hemoglobin2decisions
  • MYISystem, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies2decisions
  • GQGAntigen, Cf (Including Cf Controls), Respiratory Syncytial Virus2decisions

Also: JIT (1), GTY (1), CGJ (1), MJZ (1), JWX (1), DFC (1).

Whose devices does it build on?

Its devices cite 25 predicates; 7 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 28 times; 7 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.

  • K021649Binax Now Flu a Test (27 Test), Binax Now Nasopharyngeal Swab Specimen Accesory PackBinax, Inc. · 20025cite it
  • K062109Binaxnow Influenza a & B TestBinax, Inc. · 20064cite it
  • K021646Binax Now Flu B Test (27 Test), Binax Now Nasopharyngeal Swab Specimen Accesory PackBinax, Inc. · 20023cite it
  • K982238Binax Now Legionella Urinary Antigen Test Model 852-020 and Binax Now Leg Ionella Urinary Antigen Control…Binax, Inc. · 19983cite it
  • K091766Clearview Exact PBP2A Test, Model 891-000Binax, Inc. · 20102cite it
  • K032166Binax Now RSV Test, Model 430-000 and Binax Now Nasopharyngeal Swab Accessory Pack, Model 400-065Binax, Inc. · 20032cite it

What has FDA decided for it lately?

  • K090301Binaxnow PBP2A Test, Model 890-000Binax, Inc. · 2010
  • K091766Clearview Exact PBP2A Test, Model 891-000Binax, Inc. · 2010
  • K090964Binaxnox Staphylococcus Aureus TestBinax, Inc. · 2009
  • K091489Clearview Advanced Strep a , Model 737-430Binax, Inc. · 2009
  • K083744Binaxnow Malaria Positive Control Kit, Model 665-010Binax, Inc. · 2009
  • K092223Modification to: Binaxnow Influenza a & B TestBinax, Inc. · 2009
  • K080003Binaxnow G6PD TestBinax, Inc. · 2008
  • K062109Binaxnow Influenza a & B TestBinax, Inc. · 20062 recalls

All 30 as Binax, Inc. →

What has been recalled?

6 recalls linked to its devices; the latest:

  • K012521BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025Aug 20, 2024Class II
  • K032166BinaxNOW RSV 10 Test Kit Part Number : 430-100, contains NP Swabs with '8995' labeled on…Mar 28, 2007
  • K062109BinaxNOW Influenza A&B 10 Test KIT Part Number: 416-110 contains NP Swabs with '8995'…Mar 28, 2007
  • K062109BinaxNOW Influenza A&B 22 Test Kit Part Number: 416-022, contains NP Swabs with '8995'…Mar 28, 2007
  • K982238NOW Legionella Urinary Antigen Test. 22 test kit. For In Vitro Diagnostic Use Product…Sep 29, 2006
  • K032166NOW RSV Test Item Number 430-430, Kit Number 430-00RFeb 18, 2004