Cleared Special

Aptima BV Assay; Aptima CV/TV Assay

K243345 · Hologic, Inc. · Microbiology

Nov 2024

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K243345 is an FDA 510(k) clearance for the Aptima BV Assay; Aptima CV/TV Assay, a Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System (Class II — Special Controls, product code PQA), submitted by Hologic, Inc. (San Diedgo, US). The FDA issued a Cleared decision on November 25, 2024, 28 days after receiving the submission on October 28, 2024. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3975.

Submission Details

510(k) Number	K243345 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 28, 2024
Decision Date	November 25, 2024
Days to Decision	28 days
Submission Type	Special
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	PQA — Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3975
Definition	A Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System Is A Qualitative In Vitro Diagnostic Device For The Direct Detection Of Nucleic Acid Sequences From Microorganisms Associated With Vaginitis Or Bacterial Vaginosis. The Device Is Indicated For Individuals With Signs And Symptoms Of Vaginitis Or Bacterial Vaginosis And Aids In The Diagnosis Of These Vaginal Infections.