BD MAX Vaginal Panel

Q: What is the product code of K191957?

The FDA product code is PQA – Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System, a Class II (moderate risk) device regulated under 21 CFR 866.3975.

FDA 510(k) K191957 · Geneohm Sciences Canada, Inc. (Bd Diagnostics)

Substantially Equivalent

510(k) numberK191957

Submission

Device name: BD MAX Vaginal Panel
Applicant: Geneohm Sciences Canada, Inc. (Bd Diagnostics)
Quebec, CA
Received: July 23, 2019
Decision date: October 21, 2019
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: PQA – Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
Device class: Class II (moderate risk)
Regulation: 21 CFR 866.3975
Specialty: Microbiology

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.

Other 510(k)s with product code PQA

510(k)	Device	Applicant	Decision
K260021	cobas® BV/CVPQA · Traditional	Roche Molecular Systems, Inc.	07/16/2026SE
K243725	BD Vaginal PanelPQA · Special	Becton, Dickinson and Company	12/19/2024SE
K243345	Aptima BV Assay; Aptima CV/TV AssayPQA · Special	Hologic, Inc.	11/25/2024SE
K231381	Xpert Xpress MVP; GeneXpert Xpress SystemPQA · Dual Track	Cepheid	10/19/2023SE
K223653	BD Vaginal PanelPQA · Traditional	Becton, Dickinson and Company	03/06/2023SE
K221160	Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity SystemPQA · Special	Cepheid	06/07/2022SE
K212213	Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity SystemPQA · Traditional	Cepheid	02/09/2022SE
K201017	BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection KitPQA · Traditional	Geneohm Sciences Canada, Inc. (Bd Life Sciences)	10/18/2021SE
K190452	Aptima BV AssayPQA · Traditional	Hologic, Inc.	05/23/2019SE
K190472	Aptima CV/TV AssayPQA · Traditional	Hologic, Inc.	05/16/2019SE

More from Hologic, Inc.

510(k)	Device	Decision
K132822	BD Max Staphsr Assay, InstrumentNQX · Traditional	11/26/2013SE
K130470	BD Max Cdiff Assay, BD Max InstrumentOZN · Traditional	04/02/2013SE

Questions and answers

When was BD MAX Vaginal Panel cleared by the FDA?

BD MAX Vaginal Panel (K191957) received a 510(k) decision of Substantially Equivalent on October 21, 2019, 90 days after the submission was received.

What is the product code of K191957?

The FDA product code is PQA – Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System, a Class II (moderate risk) device regulated under 21 CFR 866.3975.