Cleared Special

Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System

K221160 · Cepheid · Microbiology

Jun 2022

Decision

47d

Days

Class 2

Risk

About This 510(k) Submission

K221160 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 June 7, 2022, 47 days after receiving the submission on April 21, 2022. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3975.

Submission Details

510(k) Number	K221160 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 21, 2022
Decision Date	June 07, 2022
Days to Decision	47 days
Submission Type	Special
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.