FDA.reportPublic FDA data

510(k) K231329

Device
Aptima Neisseria gonorrhoeae Assay
Applicant
Hologic, Inc.
510(k) number
K231329
Product code
LSL
Decision
Substantially Equivalent (SESE)
Decision date
2024-01-26
Date received
2023-05-08
Regulation
866.3390
Classification name
Dna-Reagents, Neisseria
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jon Kukowski
Address
10210 Genetic Center Dr. San Diego CA US 92121 92121

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LSL#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K180681Aptima Combo 2 Assay (Panther System)Hologic, Inc.2018-06-13
K173887cobas CT/NG for use on cobas 6800/8800 systemsRoche Molecular Systems, Inc.2018-03-21
K173840Xpert CT/NGCepheid2018-03-16
K163184cobas® CT/NG v2.0 TestRoche Molecular Systems, Inc.2017-02-09
K140448BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAYBecton, Dickinson & CO2014-05-20
K140354ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, ABBOTT REAL TIME CT/NGAbbott Molecular, Inc.2014-05-09
K140887COBAS CT/NG V2.0 TESTRoche Molecular Systems, Inc.2014-05-05
K132270COBAS CT/NG V2.0 TESTRoche Molecular Systems, Inc.2013-12-02
K132251APTIMA COMBO 2 ASSAY (PANTHER SYSTEM)Hologic / Gen-Probe Incorporated2013-10-17
K121710XPERT CT/NGCepheid2012-12-27
K111409APTIMA COMBO 2 ASSAYGen-Probe, Inc.2012-05-03
K091730BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAYBecton, Dickinson & CO2009-11-13
K090971BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAYBecton, Dickinson & CO2009-06-05
K090827BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAYBecton, Dickinson & CO2009-05-27
K081825BD PROBETEC NEISSERIA GONORRHOEAE (GC) Q AMPLIFIED DNA ASSAYBecton, Dickinson & CO2008-12-11