BD MAX CTGCTV2, BD MAX System

Q: What is the product code of K182692?

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) K182692 · Becton, Dickinson and Company

Substantially Equivalent

510(k) numberK182692

Submission

Device name: BD MAX CTGCTV2, BD MAX System
Applicant: Becton, Dickinson and Company
Sparks, MD, US
Received: September 27, 2018
Decision date: January 8, 2019
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
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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
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

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Questions and answers

When was BD MAX CTGCTV2, BD MAX System cleared by the FDA?

BD MAX CTGCTV2, BD MAX System (K182692) received a 510(k) decision of Substantially Equivalent on January 8, 2019, 103 days after the submission was received.

What is the product code of K182692?

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.