510(k) Report

FDA applicant

Trinity Biotech USA

Jamestown, NY11 decisions1999–20142 recalls

FDA records 11 decisions for Trinity Biotech USA (Jamestown, NY) from 1999 to 2014: 11 510(k) clearances. Most are in product codes LSR (Reagent, Borrelia Serological Reagent) and MXJ (Enzyme Linked Immunosorbent Assay, Herpes…). Its devices cite 1 predicate, 0 of them its own earlier devices. 2 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 Trinity Biotech USA’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2014: 1
2007high 1 (2014) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2021

2016: 12021: 1
2007high 1 (2016) · low 0 (2007)2026

Class I Class II/III not classified

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

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Which product codes does it file in?

  • LSRReagent, Borrelia Serological Reagent2decisions
  • MXJEnzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-11decision
  • DFCLipoprotein, Low-Density, Antigen, Antiserum, Control1decision
  • PCLEnzyme Linked Immunoabsorbent Assay, Rubeola Igm1decision
  • LONSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation1decision
  • MJHLegionella, Spp., Elisa1decision

Also: MYF (1), LJC (1), LLL (1), LYR (1).

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 0 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.

  • K033070Borrelia Burgdorferi Igm Elisa Test SystemTrinity Biotech USA · 20032cite it
  • K992665Macra LP (a) Enzyme Immunoassay KitTrinity Biotech USA · 19991cites it

What has FDA decided for it lately?

  • K140455Captia Measles IgmTrinity Biotech USA · 20142 recalls
  • K033105Captia HSV 1 Igg Type Specific Elisa KitTrinity Biotech USA · 2004
  • K033106Captia HSV 2 Igg Type Specific Elisa KitTrinity Biotech USA · 2004
  • K033064Mycoplasma IggTrinity Biotech USA · 2003
  • K033083Borrelia Burgdorferi Igg/Igm Elisa Test SystemTrinity Biotech USA · 2003
  • K033070Borrelia Burgdorferi Igm Elisa Test SystemTrinity Biotech USA · 2003
  • K033051Legionella Pneumophila Igg/IgmTrinity Biotech USA · 2003
  • K033079Chlamydia Igg Elisa Test SystemTrinity Biotech USA · 2003

All 11 as Trinity Biotech USA →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K140455Trinity Biotech Captia Measles IgM Kit, Catalog No. 2326060 - Product Usage: intended…Mar 17, 2021Class II
  • K140455Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96…Jul 11, 2016Class III

Other applicant names beginning “Trinity”

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

Trinity Laboratories, Inc. 44Trinity Biotech, Plc 12Trinity Orthopedics, LLC 2Trinity Partners, LLC 1Trinity Medical Solutions 1Trinity Biotech (Primus Corporation, Dba Trinity… 1Trinity Guardion 1