Cleared Traditional

S. AUREUS/CNS PNA FISH, MODEL KT005

K092166 · Advandx, Inc. · Microbiology
Nov 2009
Decision
125d
Days
Class 1
Risk

About This 510(k) Submission

K092166 is an FDA 510(k) clearance for the S. AUREUS/CNS PNA FISH, MODEL KT005, 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 November 23, 2009, 125 days after receiving the submission on July 21, 2009. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3700.

Submission Details

510(k) Number K092166 FDA.gov
FDA Decision Cleared SESE
Date Received July 21, 2009
Decision Date November 23, 2009
Days to Decision 125 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).