Cleared Traditional

BD Vaginal Panel

K223653 · Becton, Dickinson and Company · Microbiology

Mar 2023

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K223653 is an FDA 510(k) clearance for the BD Vaginal Panel, a Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System (Class II — Special Controls, product code PQA), submitted by Becton, Dickinson and Company (Sparks, US). The FDA issued a Cleared decision on March 6, 2023, 90 days after receiving the submission on December 6, 2022. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3975.

Submission Details

510(k) Number	K223653 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 06, 2022
Decision Date	March 06, 2023
Days to Decision	90 days
Submission Type	Traditional
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.