Cleared Traditional

BD MAX CT/GC/TV, BD MAX INSTRUMENT

K151589 · Becton, Dickinson and Company · Microbiology
Sep 2016
Decision
452d
Days
Class 2
Risk

About This 510(k) Submission

K151589 is an FDA 510(k) clearance for the BD MAX CT/GC/TV, BD MAX INSTRUMENT, 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 September 6, 2016, 452 days after receiving the submission on June 12, 2015. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3860.

Submission Details

510(k) Number K151589 FDA.gov
FDA Decision Cleared SESE
Date Received June 12, 2015
Decision Date September 06, 2016
Days to Decision 452 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

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