Cleared Traditional

ENTEROCOCCUS QUICKFISH BC

K121991 · Advandx, Inc. · Microbiology

Jan 2013

Decision

185d

Days

Class 1

Risk

About This 510(k) Submission

K121991 is an FDA 510(k) clearance for the ENTEROCOCCUS QUICKFISH BC, a Fish (fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis (Class I — General Controls, product code OAH), submitted by Advandx, Inc. (Woburn, US). The FDA issued a Cleared decision on January 7, 2013, 185 days after receiving the submission on July 6, 2012. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3740.

Submission Details

510(k) Number	K121991 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 06, 2012
Decision Date	January 07, 2013
Days to Decision	185 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Statement

Device Classification

Product Code	OAH — Fish (fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis
Device Class	Class I — General Controls
CFR Regulation	21 CFR 866.3740
Definition	E. Faecalis Pna Fish Is A Qualitative Nucleic Acid Hybridization Assay Intended For The Identification Of Enterococcus Faecalis And Other Enterococci (oe) From Blood Cultures Showing Gram-positive Cocci In Pairs And Chains.