Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

DDC — Predicate Candidate Screening

13 FDA 510(k) clearances under this product code; the 50 most recent screened below.

45 daysmedian FDA review time

149 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K023592	SERAQUEST ANTI-THYROGLOBULIN	Quest Intl., Inc.	2003-01-06	73	0
K012208	ACCESS THYROGLOBULIN ANTIBODY AND CALIBRATORS ON THE ACCESS	Beckman Coulter, Inc.	2001-09-07	53	1
K000363	MODIFICATION TO ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELI	Zeus Scientific, Inc.	2000-02-18	14	0
K991610	ZEUS SCIENTIFIC INC., TPO IGG ELISA TEST SYSTEM.	Zeus Scientific, Inc.	1999-06-25	46	0
K991179	ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM	Zeus Scientific, Inc.	1999-06-17	71	0
K971835	ANTI-THYROGLOBULIN (TG) MICROPLATE ELISA	Monobind	1997-07-03	45	0
K953066	SERODIA ATG	Fujirebio America, Inc.	1995-08-14	45	0
K943625	AUTOSTAT II ANTI-THYROGLOBULIN	Cogent Diagnotics , Ltd.	1994-12-22	149	0
K936010	THYROGLOBULIN AUTOANTIBODY ENZYME IMMUNOASSAY	Biomerica, Inc.	1994-07-18	214	0
K930486	QUANTA LITE(TM) THYROID T ELISA	Inova Diagnostics, Inc.	1993-03-15	45	0
K865020	SERA-TEK THYROGLOBULIN ANTIBODY TEST	Miles Laboratories, Inc.	1987-02-02	41	0
K780873	THYMUNE-M	Burroughs Wellcome Co.	1978-06-14	15	0
K780874	THYMUNE-T	Burroughs Wellcome Co.	1978-06-14	15	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