Atlas FDA

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

MKZ · Predicate Candidate Screening

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

170 daysmedian FDA review time
674 days90th percentile
19clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K230451Aptima® Chlamydia trachomatis AssayHologic, Inc.2023-11-162680
K140446BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSABecton, Dickinson & CO2014-05-20880
K110923COBAS 4800 CT / NG TESTRoche Molecular Systems, Inc.2012-01-242982
K091724BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAYBecton, Dickinson & CO2009-11-131550
K090824BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSABecton, Dickinson & CO2009-06-02680
K081824BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAYBecton, Dickinson & CO2008-12-111670
K080739ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLEAbbott Molecular, Inc.2008-07-101150
K070174AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS; ROCHE SCRIPTSRoche Diagnostics Corporation2007-04-16880
K063451GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1199Gen-Probe, Inc.2007-01-22680
K061413APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEMGen-Probe, Inc.2006-10-131440
K053287COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATISRoche Diagnostics Corp.2006-08-102580
K053446GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1088Gen-Probe, Inc.2006-07-252250
K043072GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATISGen-Probe, Inc.2005-01-27800
K973707ROCHE AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATISRoche Molecular Systems, Inc.1999-08-046741
K973718ROCHE COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATISRoche Molecular Systems, Inc.1998-12-154420
K964507ROCHE COBAS AMPLICOR CHLAMYDIA TRACHOMATIS TESTRoche Molecular Systems, Inc.1997-06-132170
K962217GEN-PROBE AMPLIFIED CHLAMYDIA TRACHOMATIS ASSAY KITGen-Probe, Inc.1996-11-271700
K934622LCX CHLAMYDIA TRACHOMATIS ASSAYAbbott Laboratories1995-12-088020
K922906AMPLICOR CHLAMYDIA TRACHOMATIS TESTRoche Molecular Systems, Inc.1993-06-153630

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