Cleared Traditional

GBS PNA FISH

K082612 · Advandx, Inc. · Microbiology
May 2009
Decision
238d
Days
Class 1
Risk

About This 510(k) Submission

K082612 is an FDA 510(k) clearance for the GBS 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. (Woburn, US). The FDA issued a Cleared decision on May 5, 2009, 238 days after receiving the submission on September 9, 2008. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3740.

Submission Details

510(k) Number K082612 FDA.gov
FDA Decision Cleared SESE
Date Received September 09, 2008
Decision Date May 05, 2009
Days to Decision 238 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.