Cleared Traditional

AVANDX E. FAECALIS/OE PNA FISH CULTURE IDENTIFICATION KIT

K083074 · Advandx, Inc. · Microbiology
Jul 2009
Decision
282d
Days
Class 1
Risk

About This 510(k) Submission

K083074 is an FDA 510(k) clearance for the AVANDX E. FAECALIS/OE PNA FISH CULTURE IDENTIFICATION KIT, 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 July 24, 2009, 282 days after receiving the submission on October 15, 2008. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3740.

Submission Details

510(k) Number K083074 FDA.gov
FDA Decision Cleared SESE
Date Received October 15, 2008
Decision Date July 24, 2009
Days to Decision 282 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.