Cleared Traditional

BD PROBETEC TRICHOMONAS VAGINALIS (TV) QX AMPLIFIED DNA ASSAY

K130268 · Becton, Dickinson & CO · Microbiology

Aug 2013

Decision

200d

Days

Class 2

Risk

About This 510(k) Submission

K130268 is an FDA 510(k) clearance for the BD PROBETEC TRICHOMONAS VAGINALIS (TV) QX AMPLIFIED DNA ASSAY, a Trichomonas Vaginalis Nucleic Acid Amplification Test System (Class II — Special Controls, product code OUY), submitted by Becton, Dickinson & CO (Sparks, US). The FDA issued a Cleared decision on August 23, 2013, 200 days after receiving the submission on February 4, 2013. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3860.

Submission Details

510(k) Number	K130268 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 04, 2013
Decision Date	August 23, 2013
Days to Decision	200 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