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

LSK · Predicate Candidate Screening

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

183 daysmedian FDA review time

806 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K092704	ABBOTT REALTIME CT/NG AND ABBOTT MULTI-COLLECT SPECIMEN COLL	Abbott Molecular, Inc.	2010-05-28	267	1
K010891	MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01	Digene Corp.	2001-09-25	183	0
K010892	MODIFICATION HYBRID CAPTURE II CT-ID DNA TEST, MODEL 03M91-0	Digene Corp.	2001-09-24	182	0
K990023	HYBRID CAPTURE II CT-ID TEST	Digene Corp.	1999-10-25	293	1
K920302	PACE 2 CHLAMYDIA TRACHOMATIS PROBE CONFIRM ASSAY	Gen-Probe, Inc.	1994-04-06	806	0
K920378	PACE 2 SYSTEM FOR CHLAMYDIA TRACHOMATIS	Gen-Probe, Inc.	1992-04-29	91	0
K874878	GEN-PROBE(R) PACE(TM) SYSTEM CHLAMYDIA TRACHOMATIS	Gen-Probe, Inc.	1987-12-29	29	0
K871878	RAPID DIAGNOSTIC SYSTEM FOR CHLAMYDIA TRACHOMATIS	Gen-Probe, Inc.	1987-10-28	167	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