Cleared Traditional

BD MAX MRSA XT, BD MAX INSTRUMENT

K133605 · Geneohm Sciences Canada, Inc. · Microbiology

Dec 2013

Decision

25d

Days

Class 2

Risk

About This 510(k) Submission

K133605 is an FDA 510(k) clearance for the BD MAX MRSA XT, BD MAX INSTRUMENT, a System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen (Class II — Special Controls, product code NQX), submitted by Geneohm Sciences Canada, Inc. (Quebec, CA). The FDA issued a Cleared decision on December 20, 2013, 25 days after receiving the submission on November 25, 2013. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number	K133605 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 25, 2013
Decision Date	December 20, 2013
Days to Decision	25 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.