Cleared Traditional

S. AUREUS PNA FISH

K091827 · Advandx, Inc. · Microbiology

Aug 2009

Decision

60d

Days

Class 1

Risk

About This 510(k) Submission

K091827 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. (Woburn, US). The FDA issued a Cleared decision on August 18, 2009, 60 days after receiving the submission on June 19, 2009. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3700.

Submission Details

510(k) Number	K091827 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 19, 2009
Decision Date	August 18, 2009
Days to Decision	60 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).