Cleared Traditional

BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit

K201017 · Geneohm Sciences Canada, Inc. (Bd Life Sciences) · Microbiology

Oct 2021

Decision

549d

Days

Class 2

Risk

About This 510(k) Submission

K201017 is an FDA 510(k) clearance for the BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit, a Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System (Class II — Special Controls, product code PQA), submitted by Geneohm Sciences Canada, Inc. (Bd Life Sciences) (Quebec, CA). The FDA issued a Cleared decision on October 18, 2021, 549 days after receiving the submission on April 17, 2020. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3975.

Submission Details

510(k) Number	K201017 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 17, 2020
Decision Date	October 18, 2021
Days to Decision	549 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.