Cleared Traditional

Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48S System and GeneXpert Infinity-80 System

K181289 · Cepheid · Microbiology

Aug 2018

Decision

91d

Days

Class 2

Risk

About This 510(k) Submission

K181289 is an FDA 510(k) clearance for the Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48S System and GeneXpert Infinity-80 System, a Respiratory Virus Panel Nucleic Acid Assay System (Class II — Special Controls, product code OCC), submitted by Cepheid (Sunnyvale, US). The FDA issued a Cleared decision on August 15, 2018, 91 days after receiving the submission on May 16, 2018. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3980.

Submission Details

510(k) Number	K181289 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 16, 2018
Decision Date	August 15, 2018
Days to Decision	91 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	OCC — Respiratory Virus Panel Nucleic Acid Assay System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3980
Definition	A Respiratory Viral Panel Multiplex Nucleic Acid Assay Is A Qualitative In Vitro Diagnostic Device Intended To Simultaneously Detect And Identify Multiple Viral Nucleic Acids Extracted From Human Respiratory Specimens Or Viral Culture. The Detection And Identification Of A Specific Viral Nucleic Acid From Individuals Exhibiting Signs And Symptoms Of Respiratory Infection Aids In The Diagnosis Of Respiratory Viral Infection When Used In Conjunction With Other Clinical And Laboratory Findings. The Device Is Intended For Detection And Identification Of A Combination Of The Following Viruses: Influenza A And Influenza B, Influenza A Subtype H1 And Influenza A Subtype H3, Respiratory Syncytial Virus Subtype A And Respiratory Syncytial Virus Subtype B, Parainfluenza 1, Parainfluenza 2, And Parainfluenza 3 Virus, Human Metapneumovirus, Rhinovirus, And Adenovirus.