Cleared Traditional

Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System

K212213 · Cepheid · Microbiology

Feb 2022

Decision

209d

Days

Class 2

Risk

About This 510(k) Submission

K212213 is an FDA 510(k) clearance for the Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System, a Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System (Class II — Special Controls, product code PQA), submitted by Cepheid (Sunnyvale, US). The FDA issued a Cleared decision on February 9, 2022, 209 days after receiving the submission on July 15, 2021. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3975.

Submission Details

510(k) Number	K212213 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 15, 2021
Decision Date	February 09, 2022
Days to Decision	209 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.