Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Trinity Biotech — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
185 daysmedian FDA review time
423 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K172254 | Lyme B. burgdorferi (IgM) MarStripe Test | Trinity Biotech | 2017-10-23 | 89 | 0 |
| K163095 | Lyme B. burgdorferi (IgG) MarStripe Test | Trinity Biotech | 2017-02-01 | 89 | 0 |
| K120001 | UNIGOLD GIARDIA | Trinity Biotech | 2013-03-01 | 423 | 0 |
| K121565 | UNI-GOLD CRYPTOSPORIDIUM | Trinity Biotech | 2013-02-08 | 255 | 0 |
| K083896 | DESTINY MAX COAGULATION ANALYZER | Trinity Biotech | 2009-07-02 | 185 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda