Xpert® 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 Kit

Q: What is the product code of K151565?

The FDA product code is OUY – Trichomonas Vaginalis Nucleic Acid Amplification Test System, a Class II (moderate risk) device regulated under 21 CFR 866.3860.

FDA 510(k) K151565 · Cepheid

Substantially Equivalent

510(k) numberK151565

Submission

Device name: Xpert® 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 Kit
Applicant: Cepheid
Sunnyvale, CA, US
Received: June 10, 2015
Decision date: October 16, 2015
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: OUY – Trichomonas Vaginalis Nucleic Acid Amplification Test System
Device class: Class II (moderate risk)
Regulation: 21 CFR 866.3860
Specialty: Immunology

In vitro nucleic acid amplification test for the qualitative detection of ribosomal rna from trichomonas vaginalis as an aid in the diagnosis of trichomoniasis from vaginal, cervical, urogenital and gynecological specimens from symptomatic patients

Other 510(k)s with product code OUY

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K231316	Aptima Trichomonas vaginalis AssayOUY · Traditional	Hologic, Inc.	11/06/2023SE
K182692	BD MAX CTGCTV2, BD MAX SystemOUY · Traditional	Becton, Dickinson and Company	01/08/2019SE
K151589	BD Max Ct/Gc/Tv, BD Max InstrumentOUY · Traditional	Becton, Dickinson and Company	09/06/2016SE
K161619	Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV…OUY · Traditional	Cepheid	08/29/2016SE
K161182	Solana Trichomonas AssayOUY · Traditional	Quidel Corporation	08/15/2016SE
K143329	AmpliVue Trichomonas AssayOUY · Traditional	Quidel Corporation	03/17/2015SE
K130268	BD Probetec Trichomonas Vaginalis (TV) QX Amplified DNA AssayOUY · Traditional	Becton, Dickinson & CO	08/23/2013SE
K122062	Aptima Trichomonas Vaginalis Assay - PantherOUY · Traditional	Gen-Probe, Inc.	01/09/2013SE

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K250218	Xpert® FII & FVNPR · Special	02/21/2025SE
K242109	Xpert® Xpress CoV-2 plus (XPRS-COV2-10)QQX · Dual Track	01/15/2025SE
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Questions and answers

When was Xpert® 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 Kit cleared by the FDA?

Xpert® 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 Kit (K151565) received a 510(k) decision of Substantially Equivalent on October 16, 2015, 128 days after the submission was received.

What is the product code of K151565?

The FDA product code is OUY – Trichomonas Vaginalis Nucleic Acid Amplification Test System, a Class II (moderate risk) device regulated under 21 CFR 866.3860.