Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Trinity Biotech USA — Predicate Candidate Screening

11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

58 daysmedian FDA review time

287 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K140455	CAPTIA MEASLES IGM	Trinity Biotech USA	2014-05-22	87	1
K033106	CAPTIA HSV 2 IGG TYPE SPECIFIC ELISA KIT	Trinity Biotech USA	2004-07-13	287	0
K033105	CAPTIA HSV 1 IGG TYPE SPECIFIC ELISA KIT	Trinity Biotech USA	2004-07-13	287	0
K033070	BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM	Trinity Biotech USA	2003-11-26	58	0
K033051	LEGIONELLA PNEUMOPHILA IGG/IGM	Trinity Biotech USA	2003-11-26	58	0
K033064	MYCOPLASMA IGG	Trinity Biotech USA	2003-11-26	58	0
K033079	CHLAMYDIA IGG ELISA TEST SYSTEM	Trinity Biotech USA	2003-11-26	58	0
K033083	BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM	Trinity Biotech USA	2003-11-26	58	0
K033067	PYLORI IGG	Trinity Biotech USA	2003-11-26	58	0
K993839	ENA PROFILE ELISA TEST SYSTEM	Trinity Biotech USA	2000-01-12	61	0
K992665	MACRA LP(A) ENZYME IMMUNOASSAY KIT	Trinity Biotech USA	1999-11-26	109	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