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510(k) K231316

Device
Aptima Trichomonas vaginalis Assay
Applicant
Hologic, Inc.
510(k) number
K231316
Product code
OUY
Decision
Substantially Equivalent (SESE)
Decision date
2023-11-06
Date received
2023-05-08
Regulation
866.3860
Classification name
Trichomonas Vaginalis Nucleic Acid Amplification Test System
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jingwen Chen
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 OUY#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K182692BD MAX CTGCTV2, BD MAX SystemBecton, Dickinson and Company2019-01-08
K151589BD MAX CT/GC/TV, BD MAX INSTRUMENTBecton, Dickinson and Company2016-09-06
K161619Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48, Genxpert Infinity-48s and GeneXpert Infinity-80 SystemsCepheid2016-08-29
K161182Solana Trichomonas AssayQuidel Corporation2016-08-15
K151565Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpertInfinity-80 systems), Xpert Vaginal/Endocervical Specimen Collection Kit, and Xpert Urine Specimen Collection KitCepheid2015-10-16
K143329AmpliVue Trichomonas AssayQuidel Corporation2015-03-17
K130268BD PROBETEC TRICHOMONAS VAGINALIS (TV) QX AMPLIFIED DNA ASSAYBecton, Dickinson & CO2013-08-23
K122062APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHERGen-Probe, Inc.2013-01-09
DEN110012APTIMA TRICHOMONAS VAGINALIS ASSAYGen-Probe Incorporated2011-04-19