Trinity Biotech: FDA clearances and approvals
Trinity Biotech has 7 FDA 510(k) clearances (first 1997, latest 2017), across 6 product codes in 2 review panels. Median 510(k) review time: 185 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 2 | 339 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 2 | 89 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Trinity Biotech's cleared 510(k)s took a median 89 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 133 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LSR | Reagent, Borrelia Serological Reagent | 2 | 2 |
| JPA | System, Multipurpose For In Vitro Coagulation Studies | 1 | 1 |
| LGC | Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific | 1 | 1 |
| LIQ | Enzyme Linked Immunoabsorbent Assay, Rotavirus | 1 | 1 |
| MHI | Giardia Spp. | 1 | 1 |
| MHJ | Cryptosporidium Spp. | 1 | 1 |
Review panels
- Microbiology (6)
- Hematology (1)
Most recent Trinity Biotech 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K172254 | Lyme B. burgdorferi (IgM) MarStripe Test | LSR | 2017-10-23 | 89 |
| K163095 | Lyme B. burgdorferi (IgG) MarStripe Test | LSR | 2017-02-01 | 89 |
| K120001 | UNIGOLD GIARDIA | MHI | 2013-03-01 | 423 |
| K121565 | UNI-GOLD CRYPTOSPORIDIUM | MHJ | 2013-02-08 | 255 |
| K083896 | DESTINY MAX COAGULATION ANALYZER | JPA | 2009-07-02 | 185 |
| K033059 | HERPES GROUP IGG | LGC | 2003-11-26 | 58 |
| K964424 | ROTAVIRUS EIA | LIQ | 1997-08-08 | 276 |
Recalls
openFDA lists no recalls under a recalling firm named Trinity Biotech.
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 have?
Trinity Biotech has 7 FDA 510(k) clearances (first 1997, latest 2017), across 6 product codes in 2 review panels.
How long does FDA take to clear Trinity Biotech's 510(k)s?
The median time from FDA receipt to decision across Trinity Biotech's cleared 510(k)s is 185 days.
What devices does Trinity Biotech make?
Its most frequent FDA product codes are LSR (Reagent, Borrelia Serological Reagent, 2); JPA (System, Multipurpose For In Vitro Coagulation Studies, 1); LGC (Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific, 1).
Has Trinity Biotech had device recalls?
openFDA lists no recalls under a recalling firm name matching Trinity Biotech. Related entities may recall under other names.
Next steps
- See all 7 Trinity Biotech clearances with predicates and recalls
- Run predicate analysis for product code LSR, Trinity Biotech'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.