FDA.reportPublic FDA data

510(k) K130268

Device
BD PROBETEC TRICHOMONAS VAGINALIS (TV) QX AMPLIFIED DNA ASSAY
Applicant
BECTON, DICKINSON & CO.
510(k) number
K130268
Product code
OUY  
Decision
Substantially Equivalent (SESE)
Decision date
2013-08-23
Date received
2013-02-04
Regulation
866.3860
Classification name
Trichomonas Vaginalis Nucleic Acid Amplification Test System
Medical specialty
Immunology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
EMILY HOWARD
Address
7loveton Cir. Sparks MD US 21152 21152

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
K231316Aptima Trichomonas vaginalis AssayHologic, Inc.2023-11-06
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
K122062APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHERGen-Probe, Inc.2013-01-09
DEN110012APTIMA TRICHOMONAS VAGINALIS ASSAYGen-Probe Incorporated2011-04-19

Legacy Summary#

summary

FDA Review#

Decision Summary