Atlas FDA

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

Gen-Probe, Inc. — Predicate Candidate Screening

62 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

113 daysmedian FDA review time
244 days90th percentile
62clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K122062APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHERGen-Probe, Inc.2013-01-091800
K111409APTIMA COMBO 2 ASSAYGen-Probe, Inc.2012-05-033500
K063664GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE MODEL#1091Gen-Probe, Inc.2007-01-25480
K063451GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1199Gen-Probe, Inc.2007-01-22680
K062440GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1091Gen-Probe, Inc.2006-11-07780
K061413APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEMGen-Probe, Inc.2006-10-131440
K061509TIGRIS DTS GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE,Gen-Probe, Inc.2006-10-041250
K060652TIGRIS DTS GEN-PROBE APTIMA COMBO 2 ASSAYGen-Probe, Inc.2006-08-171570
K053446GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1088Gen-Probe, Inc.2006-07-252250
K043224GEN-PROBE APTIMA COMBO 2 ASSAYGen-Probe, Inc.2005-08-092600
K043144GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAEGen-Probe, Inc.2005-03-141190
K043072GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATISGen-Probe, Inc.2005-01-27800
K032554GEN-PROBE APTIMA COMBO 2 ASSAYGen-Probe, Inc.2003-12-311340
K032194TIGRIS DTS AUTOMATED ANALYZER FOR AUTOMATING AMPLIFIED NUCLEGen-Probe, Inc.2003-12-241590
K022874GEN-PROBE APTIMA COMBO 2 ASSAYGen-Probe, Inc.2002-09-17530
K003395GEN-PROBE APTIMA COMBO 2 ASSAYGen-Probe, Inc.2001-05-212011
K962217GEN-PROBE AMPLIFIED CHLAMYDIA TRACHOMATIS ASSAY KITGen-Probe, Inc.1996-11-271700
K940979GEN-PROBE PACE 2C SYST CHLAMYDIA TRAC/NEISSER GONORRGen-Probe, Inc.1994-10-312440
K920301PACE 2 NEISSERIA GONORRHOEAE PROBE CONFIRM. ASSAYGen-Probe, Inc.1994-04-268260
K920302PACE 2 CHLAMYDIA TRACHOMATIS PROBE CONFIRM ASSAYGen-Probe, Inc.1994-04-068060
K924715GEN-PROBE DIRECT GROUP A STREPTOCOCUS TESTGen-Probe, Inc.1994-03-115360
K921435ACCUPROBE MYCOBACTERIUM AVIUM COMPLEX CULTUREGen-Probe, Inc.1992-07-231201
K920378PACE 2 SYSTEM FOR CHLAMYDIA TRACHOMATISGen-Probe, Inc.1992-04-29910
K915852ACCUPACE GROUP A STREPTOCOCCUS ID TESTGen-Probe, Inc.1992-04-02970
K905762GEN-PROBE LUMINOMETER-LEADER 450Gen-Probe, Inc.1991-01-23270
K904268ACCUPROBE STREPTOCOCCUS PYOGENES CULTURE CONFIRM.Gen-Probe, Inc.1990-11-13560
K904463ACCUPROBE MYCOBACTERIUM KANSASII CULT CONFIRM TESTGen-Probe, Inc.1990-11-13430
K903911GEN-PROBE PAL LUMINOMETERGen-Probe, Inc.1990-10-04410
K903556ACCUPROBE CRYPTOCOCCUS NEOFORMANS CULTURE TESTGen-Probe, Inc.1990-10-02560
K904047ACCUPROBE COCCIDIOIDES IMMITIS CULTURE CONFIRM.Gen-Probe, Inc.1990-10-02280
K903934GEN-PROBE LUMINOMETER-LEADER 50Gen-Probe, Inc.1990-09-27310
K903201ACCUPROBE BLASTOMYCES DERMATIT CULT CONFIRM TESTGen-Probe, Inc.1990-09-12540
K897077ACCUPROBE MYCOBACTERIUM INTRACELLULARE CULTUREGen-Probe, Inc.1990-08-232440
K896494ACCUPROBE MYCOBACTERIUM AVIUM CULTURE TESTGen-Probe, Inc.1990-08-232830
K902213ACCUPROBE STAPHYLOCOCCUS AUREUS CULTURE CONFIRMA.Gen-Probe, Inc.1990-08-06820
K902908ACCUPROBE STREPTOCOCCUS PNEUMONIAE CULTURE CONFIR.Gen-Probe, Inc.1990-08-06350
K901397ACCUPROBE LISTERIA MONOCYTOGENES CULTURE CONFIRMA.Gen-Probe, Inc.1990-06-20860
K897078ACCUPROBE MYCOBACTERIUM AVIUM COMPLEX CULTUREGen-Probe, Inc.1990-05-021310
K896492ACCUPROBE MYCOBACTERIUM GORDONAE CULTURE TESTGen-Probe, Inc.1990-04-161540
K896493ACCUPROBE MYCOBACTERIUM TUBERCULOSIS COMPLEX TESTGen-Probe, Inc.1990-04-111491
K897079ACCUPROBE HAEOMPHILUS INFLUENZAE CULTUREGen-Probe, Inc.1990-03-08760
K896859ACCUPROBE HISTOPLASMA CAPSULATUM CULTURE CONF.TESTGen-Probe, Inc.1990-02-01580
K895103ACCUPROBE ENTEROCOCCUS CULTURE CONFIRMATIONGen-Probe, Inc.1989-11-291060
K894712ACCUPROBE CAMPYLOBACTER CULTURE CONFIRMATIONGen-Probe, Inc.1989-11-141110
K895583ACCUPROBE NEISSERIA GONORRHOEAE CULTURE CONFIRMA.Gen-Probe, Inc.1989-11-14600
K894711ACCUPROBE GROUP B STREPTOCOCCUS CULTURE CONFIRMA.Gen-Probe, Inc.1989-11-141110
K892216GEN-PROBE PACE SYSTEM URINE SCREENGen-Probe, Inc.1989-09-151650
K890089RAPID DIAG. SYSTEM FOR MYCOBACTERIUM GORDONAEGen-Probe, Inc.1989-03-13620
K881277PACE SYSTEM FOR NEISSERIA GONORRHOEAE ADDI. CLAIMSGen-Probe, Inc.1988-04-25380
K874620GEN-PROBE PACE SYSTEM FOR NEISSERIA GONORRHOEAEGen-Probe, Inc.1988-03-011130

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