Cleared Traditional

AmpliVue Trichomonas Assay

K143329 · Quidel Corporation · Microbiology

Mar 2015

Decision

117d

Days

Class 2

Risk

About This 510(k) Submission

K143329 is an FDA 510(k) clearance for the AmpliVue Trichomonas Assay, a Trichomonas Vaginalis Nucleic Acid Amplification Test System (Class II — Special Controls, product code OUY), submitted by Quidel Corporation (Athens, US). The FDA issued a Cleared decision on March 17, 2015, 117 days after receiving the submission on November 20, 2014. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3860.

Submission Details

510(k) Number	K143329 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 20, 2014
Decision Date	March 17, 2015
Days to Decision	117 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