Cleared Traditional

C. ALBICANS/C. GLABRATA PNA FISH

K092784 · Advandx, Inc. · Microbiology

Mar 2010

Decision

183d

Days

Class 1

Risk

About This 510(k) Submission

K092784 is an FDA 510(k) clearance for the C. ALBICANS/C. GLABRATA 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 March 12, 2010, 183 days after receiving the submission on September 10, 2009. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number	K092784 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 10, 2009
Decision Date	March 12, 2010
Days to Decision	183 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.