Cleared Traditional

S. AUREUS PNA FISH

K060099 · Advandx, Inc. · Microbiology

May 2006

Decision

115d

Days

Class 1

Risk

About This 510(k) Submission

K060099 is an FDA 510(k) clearance for the S. AUREUS PNA FISH, a Fish (fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus (Class I — General Controls, product code NXX), submitted by Advandx, Inc. (Canton, US). The FDA issued a Cleared decision on May 8, 2006, 115 days after receiving the submission on January 13, 2006. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3700.

Submission Details

510(k) Number	K060099 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 13, 2006
Decision Date	May 08, 2006
Days to Decision	115 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Statement

Device Classification

Product Code	NXX — Fish (fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus
Device Class	Class I — General Controls
CFR Regulation	21 CFR 866.3700
Definition	The S. Aureus Pna Fish Is A Qualitative Nucleic Acid Hybridization Assay Intended For Presumptive Identification Of Staphylococcus Aureus From Blood Cultures With Gram-positive Cocci In Clusters (gpcc). This Device Is Not Exempt Per 21 Cfr Part 866.9(c)(6).