Cleared Traditional

K113371 - STAPHYLOCOCCUS QUICKFISH BC
(FDA 510(k) Clearance)

K113371 · Advandx, Inc. · Microbiology

Apr 2012

Decision

139d

Days

Class 1

Risk

K113371 is an FDA 510(k) clearance for the STAPHYLOCOCCUS QUICKFISH BC, a Fish (fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus (Class I — General Controls, product code NXX), submitted by Advandx, Inc. (Woburn, US). The FDA issued a Cleared decision on April 3, 2012, 139 days after receiving the submission on November 16, 2011. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3700.

Submission Details

510(k) Number	K113371 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 16, 2011
Decision Date	April 03, 2012
Days to Decision	139 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Statement

Device Classification

Product Code	NXX — Fish (fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus
Device Class	Class I — General Controls
CFR Regulation	21 CFR 866.3700
Definition	The S. Aureus Pna Fish Is A Qualitative Nucleic Acid Hybridization Assay Intended For Presumptive Identification Of Staphylococcus Aureus From Blood Cultures With Gram-positive Cocci In Clusters (gpcc). This Device Is Not Exempt Per 21 Cfr Part 866.9(c)(6).