Cleared Special

Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System

K190771 · Cepheid · Microbiology

Apr 2019

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K190771 is an FDA 510(k) clearance for the Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System, a System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen (Class II — Special Controls, product code NQX), submitted by Cepheid (Sunnyvale, US). The FDA issued a Cleared decision on April 25, 2019, 30 days after receiving the submission on March 26, 2019. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number	K190771 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 26, 2019
Decision Date	April 25, 2019
Days to Decision	30 days
Submission Type	Special
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	NQX — System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.1640
Definition	A Nucleic Acid Amplification Assay System (including Probes, Other Reagents, And Instrumentation) Is An Aid In The Identification Of Mrsa Colonization Status For The Prevention And Control Of Mrsa Infections In Healthcare Settings.