Cleared Traditional

APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER

K122062 · Gen-Probe, Inc. · Microbiology

Jan 2013

Decision

180d

Days

Class 2

Risk

About This 510(k) Submission

K122062 is an FDA 510(k) clearance for the APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER, a Trichomonas Vaginalis Nucleic Acid Amplification Test System (Class II — Special Controls, product code OUY), submitted by Gen-Probe, Inc. (San Diego, US). The FDA issued a Cleared decision on January 9, 2013, 180 days after receiving the submission on July 13, 2012. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3860.

Submission Details

510(k) Number	K122062 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 13, 2012
Decision Date	January 09, 2013
Days to Decision	180 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