Cleared Traditional

ARIES MRSA Assay

K191742 · Luminex Corporation · Microbiology

Sep 2019

Decision

86d

Days

Class 2

Risk

About This 510(k) Submission

K191742 is an FDA 510(k) clearance for the ARIES MRSA Assay, a System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen (Class II — Special Controls, product code NQX), submitted by Luminex Corporation (Austin, US). The FDA issued a Cleared decision on September 25, 2019, 86 days after receiving the submission on July 1, 2019. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number	K191742 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 01, 2019
Decision Date	September 25, 2019
Days to Decision	86 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.