Cleared Traditional

Aptima Trichomonas vaginalis Assay

K231316 · Hologic, Inc. · Microbiology

Nov 2023

Decision

182d

Days

Class 2

Risk

About This 510(k) Submission

K231316 is an FDA 510(k) clearance for the Aptima Trichomonas vaginalis Assay, a Trichomonas Vaginalis Nucleic Acid Amplification Test System (Class II — Special Controls, product code OUY), submitted by Hologic, Inc. (San Diedgo, US). The FDA issued a Cleared decision on November 6, 2023, 182 days after receiving the submission on May 8, 2023. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3860.

Submission Details

510(k) Number	K231316 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 08, 2023
Decision Date	November 06, 2023
Days to Decision	182 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