Cleared Traditional

cobas MRSA/SA Test

K142721 · Roche Molecular Systems, Inc. · Microbiology

Dec 2014

Decision

85d

Days

Class 2

Risk

About This 510(k) Submission

K142721 is an FDA 510(k) clearance for the cobas MRSA/SA Test, a System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen (Class II — Special Controls, product code NQX), submitted by Roche Molecular Systems, Inc. (Pleasanton, US). The FDA issued a Cleared decision on December 17, 2014, 85 days after receiving the submission on September 23, 2014. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number	K142721 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 23, 2014
Decision Date	December 17, 2014
Days to Decision	85 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.