Cleared Traditional

YEAST TRAFFIC LIGHT PNA FISH

K093024 · Advandx, Inc. · Microbiology

Jul 2010

Decision

289d

Days

Class 1

Risk

About This 510(k) Submission

K093024 is an FDA 510(k) clearance for the YEAST TRAFFIC LIGHT PNA FISH, a Fish (fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Yeast (Class I — General Controls, product code NZS), submitted by Advandx, Inc. (Woburn, US). The FDA issued a Cleared decision on July 15, 2010, 289 days after receiving the submission on September 29, 2009. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number	K093024 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 29, 2009
Decision Date	July 15, 2010
Days to Decision	289 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Statement

Device Classification

Product Code	NZS — Fish (fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Yeast
Device Class	Class I — General Controls
CFR Regulation	21 CFR 866.2660
Definition	Indicated As A Qualitative Nucleic Acid Hybridization Assay Intended For Identification Of Candida Albicans From Blood Cultures With Yeast.