Cleared Traditional

Xpert MRSA NxG

K162444 · Cepheid · Microbiology

Nov 2016

Decision

84d

Days

Class 2

Risk

About This 510(k) Submission

K162444 is an FDA 510(k) clearance for the Xpert MRSA NxG, 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 November 23, 2016, 84 days after receiving the submission on August 31, 2016. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number	K162444 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 31, 2016
Decision Date	November 23, 2016
Days to Decision	84 days
Submission Type	Traditional
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.