Xpert 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 Systems

Q: What is the product code of K161619?

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) K161619 · Cepheid

Substantially Equivalent

510(k) numberK161619

Submission

Device name: Xpert 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 Systems
Applicant: Cepheid
Sunnyvale, CA, US
Received: June 13, 2016
Decision date: August 29, 2016
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

510(k)	Device	Applicant	Decision
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
K161182	Solana Trichomonas AssayOUY · Traditional	Quidel Corporation	08/15/2016SE
K151565	Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert…OUY · Traditional	Cepheid	10/16/2015SE
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

More from Gen-Probe, Inc.

510(k)	Device	Decision
K261362	Xpert Hemorrhagic FeverQVR · Dual Track	08/07/2026SE
K261867	Xpert Carba-RPOC · Special	07/02/2026SE
K253653	Xpert Hemorrhagic Fever · Traditional	02/20/2026SE
K251721	Xpert GI PanelPCH · Traditional	01/16/2026SE
K250996	Xpert Xpress CoV-2/Flu/RSV plusQOF · Special	05/01/2025SE
K250995	Xpert Xpress CoV-2/Flu/RSV plusQOF · Special	05/01/2025SE
K243730	Xpert C. difficile/EpiOZN · Traditional	02/28/2025SE
K250218	Xpert® FII & FVNPR · Special	02/21/2025SE
K242109	Xpert® Xpress CoV-2 plus (XPRS-COV2-10)QQX · Dual Track	01/15/2025SE
K242071	Xpert Xpress CoV-2/Flu/RSV plusQOF · Dual Track	01/10/2025SE

Questions and answers

When was Xpert 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 Systems cleared by the FDA?

Xpert 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 Systems (K161619) received a 510(k) decision of Substantially Equivalent on August 29, 2016, 77 days after the submission was received.

What is the product code of K161619?

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.