Cleared Traditional

BD GENEOHM MRSA ACP ASSAY

K093346 · Bd Diagnostics (Geneohm Sciences, Inc.) · Microbiology

Dec 2009

Decision

50d

Days

Class 2

Risk

About This 510(k) Submission

K093346 is an FDA 510(k) clearance for the BD GENEOHM MRSA ACP ASSAY, a System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen (Class II — Special Controls, product code NQX), submitted by Bd Diagnostics (Geneohm Sciences, Inc.) (San Diego, US). The FDA issued a Cleared decision on December 15, 2009, 50 days after receiving the submission on October 26, 2009. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number	K093346 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 26, 2009
Decision Date	December 15, 2009
Days to Decision	50 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.