Trinity Biotech USA: FDA clearances and approvals
Trinity Biotech USA has 11 FDA 510(k) clearances (first 1999, latest 2014), across 10 product codes in 2 review panels. Median 510(k) review time: 58 days. openFDA lists 2 product recalls by a recalling firm named Trinity Biotech USA.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 87 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LSR | Reagent, Borrelia Serological Reagent | 2 | 2 |
| DFC | Lipoprotein, Low-Density, Antigen, Antiserum, Control | 1 | 1 |
| LJC | Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group) | 1 | 1 |
| LLL | Extractable Antinuclear Antibody, Antigen And Control | 1 | 1 |
| LON | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation | 1 | 1 |
| LYR | Helicobacter Pylori | 1 | 1 |
| MJH | Legionella, Spp., Elisa | 1 | 1 |
| MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | 1 | 1 |
| MYF | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 | 1 | 1 |
| PCL | Enzyme Linked Immunoabsorbent Assay, Rubeola Igm | 1 | 1 |
Review panels
- Microbiology (9)
- Immunology (2)
Most recent Trinity Biotech USA 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K140455 | CAPTIA MEASLES IGM | PCL | 2014-05-22 | 87 |
| K033106 | CAPTIA HSV 2 IGG TYPE SPECIFIC ELISA KIT | MYF | 2004-07-13 | 287 |
| K033105 | CAPTIA HSV 1 IGG TYPE SPECIFIC ELISA KIT | MXJ | 2004-07-13 | 287 |
| K033083 | BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM | LSR | 2003-11-26 | 58 |
| K033079 | CHLAMYDIA IGG ELISA TEST SYSTEM | LJC | 2003-11-26 | 58 |
| K033070 | BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM | LSR | 2003-11-26 | 58 |
| K033067 | PYLORI IGG | LYR | 2003-11-26 | 58 |
| K033064 | MYCOPLASMA IGG | LON | 2003-11-26 | 58 |
| K033051 | LEGIONELLA PNEUMOPHILA IGG/IGM | MJH | 2003-11-26 | 58 |
| K993839 | ENA PROFILE ELISA TEST SYSTEM | LLL | 2000-01-12 | 61 |
1 earlier clearances. See the full list in Caduvo.
Recalls
2 product recalls in 2 recall events; 1 initiated in the last five years. Most recent: 2025-07-22.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Trinity Biotech USA have?
Trinity Biotech USA has 11 FDA 510(k) clearances (first 1999, latest 2014), across 10 product codes in 2 review panels.
How long does FDA take to clear Trinity Biotech USA's 510(k)s?
The median time from FDA receipt to decision across Trinity Biotech USA's cleared 510(k)s is 58 days.
What devices does Trinity Biotech USA make?
Its most frequent FDA product codes are LSR (Reagent, Borrelia Serological Reagent, 2); DFC (Lipoprotein, Low-Density, Antigen, Antiserum, Control, 1); LJC (Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group), 1).
Has Trinity Biotech USA had device recalls?
openFDA lists 2 product recalls in 2 recall events by a recalling firm whose name matches Trinity Biotech USA; the most recent began 2025-07-22. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 11 Trinity Biotech USA clearances with predicates and recalls
- Run predicate analysis for product code LSR, Trinity Biotech USA's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.