Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LSL — Predicate Candidate Screening
45 FDA 510(k) clearances under this product code; the 50 most recent screened below.
133 daysmedian FDA review time
584 days90th percentile
45clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231329 | Aptima Neisseria gonorrhoeae Assay | Hologic, Inc. | 2024-01-26 | 263 | 0 |
| K180681 | Aptima Combo 2 Assay (Panther System) | Hologic, Inc. | 2018-06-13 | 90 | 0 |
| K173887 | cobas CT/NG for use on cobas 6800/8800 systems | Roche Molecular Systems, Inc. | 2018-03-21 | 90 | 0 |
| K173840 | Xpert CT/NG | Cepheid | 2018-03-16 | 88 | 0 |
| K163184 | cobas® CT/NG v2.0 Test | Roche Molecular Systems, Inc. | 2017-02-09 | 87 | 0 |
| K140448 | BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSA | Becton, Dickinson & CO | 2014-05-20 | 88 | 0 |
| K140354 | ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, ABBOTT REAL TI | Abbott Molecular, Inc. | 2014-05-09 | 86 | 0 |
| K140887 | COBAS CT/NG V2.0 TEST | Roche Molecular Systems, Inc. | 2014-05-05 | 28 | 0 |
| K132270 | COBAS CT/NG V2.0 TEST | Roche Molecular Systems, Inc. | 2013-12-02 | 133 | 0 |
| K132251 | APTIMA COMBO 2 ASSAY (PANTHER SYSTEM) | Hologic / Gen-Probe Incorporated | 2013-10-17 | 90 | 0 |
| K121710 | XPERT CT/NG | Cepheid | 2012-12-27 | 199 | 2 |
| K111409 | APTIMA COMBO 2 ASSAY | Gen-Probe, Inc. | 2012-05-03 | 350 | 0 |
| K091730 | BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSA | Becton, Dickinson & CO | 2009-11-13 | 155 | 1 |
| K090971 | BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSA | Becton, Dickinson & CO | 2009-06-05 | 60 | 1 |
| K090827 | BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSA | Becton, Dickinson & CO | 2009-05-27 | 62 | 1 |
| K081825 | BD PROBETEC NEISSERIA GONORRHOEAE (GC) Q AMPLIFIED DNA ASSAY | Becton, Dickinson & CO | 2008-12-11 | 167 | 1 |
| K070172 | AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE | Roche Diagnostics Corporation | 2007-04-17 | 89 | 0 |
| K063664 | GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE MODEL#1091 | Gen-Probe, Inc. | 2007-01-25 | 48 | 0 |
| K062440 | GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1091 | Gen-Probe, Inc. | 2006-11-07 | 78 | 0 |
| K061509 | TIGRIS DTS GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, | Gen-Probe, Inc. | 2006-10-04 | 125 | 0 |
| K060652 | TIGRIS DTS GEN-PROBE APTIMA COMBO 2 ASSAY | Gen-Probe, Inc. | 2006-08-17 | 157 | 0 |
| K053289 | COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE | Roche Diagnostics Corp. | 2006-08-10 | 258 | 0 |
| K052481 | BD VIPER SYSTEM | Becton, Dickinson & CO | 2005-11-28 | 80 | 0 |
| K052224 | BD PROBE TEC URINE PRESERVATIVE TRANSPORT | Becton, Dickinson & CO | 2005-09-12 | 27 | 0 |
| K043224 | GEN-PROBE APTIMA COMBO 2 ASSAY | Gen-Probe, Inc. | 2005-08-09 | 260 | 0 |
| K043144 | GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE | Gen-Probe, Inc. | 2005-03-14 | 119 | 0 |
| K032554 | GEN-PROBE APTIMA COMBO 2 ASSAY | Gen-Probe, Inc. | 2003-12-31 | 134 | 0 |
| K032194 | TIGRIS DTS AUTOMATED ANALYZER FOR AUTOMATING AMPLIFIED NUCLE | Gen-Probe, Inc. | 2003-12-24 | 159 | 0 |
| K010893 | MODIFICATION TO HYBRID CAPTURE 2 GC-ID DNA TEST, MODEL 03M92 | Digene Corp. | 2001-09-24 | 182 | 0 |
| K012351 | BDPROBETEC ET CT/GC AMPLIFIED DNA ASSAY | Becton, Dickinson & CO | 2001-09-18 | 55 | 0 |
| K003395 | GEN-PROBE APTIMA COMBO 2 ASSAY | Gen-Probe, Inc. | 2001-05-21 | 201 | 1 |
| K981567 | HYBRID CAPTURE II CT/GC TEST | Digene Corp. | 2000-02-29 | 669 | 0 |
| K974503 | ROCHE AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE | Roche Molecular Systems, Inc. | 1999-12-01 | 733 | 1 |
| K981485 | HYBRID CAPTURE II GC-ID | Digene Corp. | 1999-11-29 | 584 | 0 |
| K984631 | BDPROBETEC ET CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEA | Becton Dickinson Microbiology Systems | 1999-11-04 | 309 | 2 |
| K991268 | GONOSTAT GONOCOCCAL DETECTION KIT | Sierra Diagnostics | 1999-08-11 | 120 | 0 |
| K974342 | ROCHE COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE | Roche Molecular Systems, Inc. | 1999-05-28 | 556 | 0 |
| K935833 | LCX NEISSERIA GONORRHOEAE ASSAY | Abbott Laboratories | 1996-05-06 | 881 | 0 |
| K940979 | GEN-PROBE PACE 2C SYST CHLAMYDIA TRAC/NEISSER GONORR | Gen-Probe, Inc. | 1994-10-31 | 244 | 0 |
| K920301 | PACE 2 NEISSERIA GONORRHOEAE PROBE CONFIRM. ASSAY | Gen-Probe, Inc. | 1994-04-26 | 826 | 0 |
| K895583 | ACCUPROBE NEISSERIA GONORRHOEAE CULTURE CONFIRMA. | Gen-Probe, Inc. | 1989-11-14 | 60 | 0 |
| K883486 | GONOSTAT | Technology Management & Marketing, Inc. | 1989-08-15 | 364 | 0 |
| K881277 | PACE SYSTEM FOR NEISSERIA GONORRHOEAE ADDI. CLAIMS | Gen-Probe, Inc. | 1988-04-25 | 38 | 0 |
| K874620 | GEN-PROBE PACE SYSTEM FOR NEISSERIA GONORRHOEAE | Gen-Probe, Inc. | 1988-03-01 | 113 | 0 |
| K872628 | GONOSPOT* DNA PROBE CULTURE CONFIRMATION TEST | Ortho Diagnostic Systems, Inc. | 1987-12-21 | 168 | 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