Atlas FDA

LSL

45 FDA 510(k) clearances · Product code

133 daysmedian time to decision
584 days90th percentile
45clearances measured

FDA profile

Official device name
Dna-Reagents, Neisseria
Device class
Class II (moderate risk)
Regulation
21 CFR 866.3390
Medical specialty
Microbiology
Adverse events (MAUDE)
2017: 10 · 2019: 14 · 2023: 19 · 2024: 17 · 2025: 42 · 2026: 41
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Aptima Neisseria gonorrhoeae Assay (K231329)Hologic, Inc.2024-01-26
Aptima Combo 2 Assay (Panther System) (K180681)Hologic, Inc.2018-06-13
cobas CT/NG for use on cobas 6800/8800 systems (K173887)Roche Molecular Systems, Inc.2018-03-21
Xpert CT/NG (K173840)Cepheid2018-03-16
cobas® CT/NG v2.0 Test (K163184)Roche Molecular Systems, Inc.2017-02-09
BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY (K140448)Becton, Dickinson & CO2014-05-20
ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, ABBOTT REAL TIME CT/NG (K140354)Abbott Molecular, Inc.2014-05-09
COBAS CT/NG V2.0 TEST (K140887)Roche Molecular Systems, Inc.2014-05-05
COBAS CT/NG V2.0 TEST (K132270)Roche Molecular Systems, Inc.2013-12-02
APTIMA COMBO 2 ASSAY (PANTHER SYSTEM) (K132251)Hologic / Gen-Probe Incorporated2013-10-17
XPERT CT/NG (K121710)Cepheid2012-12-27
APTIMA COMBO 2 ASSAY (K111409)Gen-Probe, Inc.2012-05-03
BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY (K091730)Becton, Dickinson & CO2009-11-13
BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY (K090971)Becton, Dickinson & CO2009-06-05
BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY (K090827)Becton, Dickinson & CO2009-05-27
BD PROBETEC NEISSERIA GONORRHOEAE (GC) Q AMPLIFIED DNA ASSAY (K081825)Becton, Dickinson & CO2008-12-11
AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE (K070172)Roche Diagnostics Corporation2007-04-17
GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE MODEL#1091 (K063664)Gen-Probe, Inc.2007-01-25
GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1091 (K062440)Gen-Probe, Inc.2006-11-07
TIGRIS DTS GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1196 (K061509)Gen-Probe, Inc.2006-10-04
TIGRIS DTS GEN-PROBE APTIMA COMBO 2 ASSAY (K060652)Gen-Probe, Inc.2006-08-17
COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE (K053289)Roche Diagnostics Corp.2006-08-10
BD VIPER SYSTEM (K052481)Becton, Dickinson & CO2005-11-28
BD PROBE TEC URINE PRESERVATIVE TRANSPORT (K052224)Becton, Dickinson & CO2005-09-12
GEN-PROBE APTIMA COMBO 2 ASSAY (K043224)Gen-Probe, Inc.2005-08-09
GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE (K043144)Gen-Probe, Inc.2005-03-14
GEN-PROBE APTIMA COMBO 2 ASSAY (K032554)Gen-Probe, Inc.2003-12-31
TIGRIS DTS AUTOMATED ANALYZER FOR AUTOMATING AMPLIFIED NUCLEIC ACID TEST ASSAYS (K032194)Gen-Probe, Inc.2003-12-24
MODIFICATION TO HYBRID CAPTURE 2 GC-ID DNA TEST, MODEL 03M92-01 (K010893)Digene Corp.2001-09-24
BDPROBETEC ET CT/GC AMPLIFIED DNA ASSAY (K012351)Becton, Dickinson & CO2001-09-18
GEN-PROBE APTIMA COMBO 2 ASSAY (K003395)Gen-Probe, Inc.2001-05-21
HYBRID CAPTURE II CT/GC TEST (K981567)Digene Corp.2000-02-29
ROCHE AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE (K974503)Roche Molecular Systems, Inc.1999-12-01
HYBRID CAPTURE II GC-ID (K981485)Digene Corp.1999-11-29
BDPROBETEC ET CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE AMPLIFIED DNA ASSAY (K984631)Becton Dickinson Microbiology Systems1999-11-04
GONOSTAT GONOCOCCAL DETECTION KIT (K991268)Sierra Diagnostics1999-08-11
ROCHE COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE (K974342)Roche Molecular Systems, Inc.1999-05-28
LCX NEISSERIA GONORRHOEAE ASSAY (K935833)Abbott Laboratories1996-05-06
GEN-PROBE PACE 2C SYST CHLAMYDIA TRAC/NEISSER GONORR (K940979)Gen-Probe, Inc.1994-10-31
PACE 2 NEISSERIA GONORRHOEAE PROBE CONFIRM. ASSAY (K920301)Gen-Probe, Inc.1994-04-26
ACCUPROBE NEISSERIA GONORRHOEAE CULTURE CONFIRMA. (K895583)Gen-Probe, Inc.1989-11-14
GONOSTAT (K883486)Technology Management & Marketing, Inc.1989-08-15
PACE SYSTEM FOR NEISSERIA GONORRHOEAE ADDI. CLAIMS (K881277)Gen-Probe, Inc.1988-04-25
GEN-PROBE PACE SYSTEM FOR NEISSERIA GONORRHOEAE (K874620)Gen-Probe, Inc.1988-03-01
GONOSPOT* DNA PROBE CULTURE CONFIRMATION TEST (K872628)Ortho Diagnostic Systems, Inc.1987-12-21

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Every clearance here is in the API, with alerts when new ones post.