Cleared Traditional

ENTEROCOCCUS FAECALIS PNA FISH

K063127 · Advandx, Inc. · Microbiology
Dec 2006
Decision
70d
Days
Class 1
Risk

About This 510(k) Submission

K063127 is an FDA 510(k) clearance for the ENTEROCOCCUS FAECALIS PNA FISH, a Fish (fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis (Class I — General Controls, product code OAH), submitted by Advandx, Inc. (Canton, US). The FDA issued a Cleared decision on December 22, 2006, 70 days after receiving the submission on October 13, 2006. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3740.

Submission Details

510(k) Number K063127 FDA.gov
FDA Decision Cleared SESE
Date Received October 13, 2006
Decision Date December 22, 2006
Days to Decision 70 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.