Cleared Dual Track

Xpert Xpress MVP; GeneXpert Xpress System

K231381 · Cepheid · Microbiology

Oct 2023

Decision

160d

Days

Class 2

Risk

About This 510(k) Submission

K231381 is an FDA 510(k) clearance for the Xpert Xpress MVP; GeneXpert Xpress 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 October 19, 2023, 160 days after receiving the submission on May 12, 2023. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3975.

Submission Details

510(k) Number	K231381 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 12, 2023
Decision Date	October 19, 2023
Days to Decision	160 days
Submission Type	Dual Track
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.