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

OUY — Predicate Candidate Screening

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

128 daysmedian FDA review time

452 days90th percentile

10clearances measured

K-number	Device	Applicant	Decided	Review days
K231316	Aptima Trichomonas vaginalis Assay	Hologic, Inc.	2023-11-06	182
K182692	BD MAX CTGCTV2, BD MAX System	Becton, Dickinson and Company	2019-01-08	103
K151589	BD MAX CT/GC/TV, BD MAX INSTRUMENT	Becton, Dickinson and Company	2016-09-06	452
K161619	Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx	Cepheid	2016-08-29	77
K161182	Solana Trichomonas Assay	Quidel Corporation	2016-08-15	110
K151565	Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems	Cepheid	2015-10-16	128
K143329	AmpliVue Trichomonas Assay	Quidel Corporation	2015-03-17	117
K130268	BD PROBETEC TRICHOMONAS VAGINALIS (TV) QX AMPLIFIED DNA ASSA	Becton, Dickinson & CO	2013-08-23	200
K122062	APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER	Gen-Probe, Inc.	2013-01-09	180
DEN110012	APTIMA TRICHOMONAS VAGINALIS ASSAY	Gen-Probe Incorporated	2011-04-19	6

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