Cleared Traditional

BD MAX CTGCTV2, BD MAX System

K182692 · Becton, Dickinson and Company · Microbiology
Jan 2019
Decision
103d
Days
Class 2
Risk

About This 510(k) Submission

K182692 is an FDA 510(k) clearance for the BD MAX CTGCTV2, BD MAX System, a Trichomonas Vaginalis Nucleic Acid Amplification Test System (Class II — Special Controls, product code OUY), submitted by Becton, Dickinson and Company (Sparks, US). The FDA issued a Cleared decision on January 8, 2019, 103 days after receiving the submission on September 27, 2018. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3860.

Submission Details

510(k) Number K182692 FDA.gov
FDA Decision Cleared SESE
Date Received September 27, 2018
Decision Date January 08, 2019
Days to Decision 103 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code OUY — Trichomonas Vaginalis Nucleic Acid Amplification Test System
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3860
Definition 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

Similar Devices — OUY Trichomonas Vaginalis Nucleic Acid Amplification Test System

All 9
Aptima Trichomonas vaginalis Assay
K231316 · Hologic, Inc. · Nov 2023
BD MAX CT/GC/TV, BD MAX INSTRUMENT
K151589 · Becton, Dickinson and Company · Sep 2016
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 · Cepheid · Aug 2016
Solana Trichomonas Assay
K161182 · Quidel Corporation · Aug 2016
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 · Cepheid · Oct 2015
AmpliVue Trichomonas Assay
K143329 · Quidel Corporation · Mar 2015

More from Becton, Dickinson and Company

View all
BD Vacutainer? Plasma Separator Tubes (PST?), BD Vacutainer? Sodium Heparin Blood Collection Tubes
K252040 · JKA · Mar 2026
0.9 % Sodium Chloride Injection, USP, BD PosiFlush? SP Syringe
K250884 · NGT · Dec 2025
BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR System, and Enteric Bacterial Panel Diluent for BD COR System
K250358 · PCI · Oct 2025
BD PhaSeal? Optima Connecting Set (C83-O); BD PhaSeal? Optima Spike Set (C180-O)
K250059 · ONB · Sep 2025
BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 ?g/mL)
K251713 · LON · Aug 2025