Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

LFH · Predicate Candidate Screening

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

103 daysmedian FDA review time

373 days90th percentile

6clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K231020	Alinity c Tricyclic Antidepressants Reagent Kit	Microgenics Corporation	2023-11-17	221	0
K213875	DRI TM Tricyclics Serum Tox Assay	Microgenics Corporation	2022-12-21	373	0
K983268	MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAY	Diagnostic Reagents, Inc.	1998-11-18	62	0
K981801	ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA	Princeton BioMeditech Corp.	1998-08-25	96	0
K961393	TRICYCLICS SERUM TOX ASSAY	Diagnostic Reagents, Inc.	1996-06-12	62	0
K953761	AXSYM TRICYCLIC ANTIDEPRESSANTS	Abbott Laboratories	1995-11-22	103	2

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