Cleared Traditional

VERIGENE STAPHYLOCOCCUS BLOOD CULTURE NUCLEIC ACID TEST (BC-S)

K112424 · Nanosphere, Inc. · Microbiology

Dec 2011

Decision

115d

Days

Class 2

Risk

About This 510(k) Submission

K112424 is an FDA 510(k) clearance for the VERIGENE STAPHYLOCOCCUS BLOOD CULTURE NUCLEIC ACID TEST (BC-S), a System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen (Class II — Special Controls, product code NQX), submitted by Nanosphere, Inc. (Northbrook, US). The FDA issued a Cleared decision on December 16, 2011, 115 days after receiving the submission on August 23, 2011. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number	K112424 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 23, 2011
Decision Date	December 16, 2011
Days to Decision	115 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.