Cleared Traditional

K092655 - C. ALBICANS PNA FISH
(FDA 510(k) Clearance)

K092655 · Advandx, Inc. · Microbiology

Jan 2010

Decision

144d

Days

Class 1

Risk

K092655 is an FDA 510(k) clearance for the C. ALBICANS PNA FISH. This device is classified as 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 January 19, 2010, 144 days after receiving the submission on August 28, 2009.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2660. Indicated As A Qualitative Nucleic Acid Hybridization Assay Intended For Identification Of Candida Albicans From Blood Cultures With Yeast..

Submission Details

510(k) Number	K092655 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 28, 2009
Decision Date	January 19, 2010
Days to Decision	144 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.