Cleared Traditional

Solana Trichomonas Assay

K161182 · Quidel Corporation · Microbiology

Aug 2016

Decision

110d

Days

Class 2

Risk

About This 510(k) Submission

K161182 is an FDA 510(k) clearance for the Solana 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 August 15, 2016, 110 days after receiving the submission on April 27, 2016. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3860.

Submission Details

510(k) Number	K161182 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 27, 2016
Decision Date	August 15, 2016
Days to Decision	110 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