Cleared Special

ARIES System

K160517 · Luminex Corporation · Microbiology

Apr 2016

Decision

48d

Days

Class 2

Risk

About This 510(k) Submission

K160517 is an FDA 510(k) clearance for the ARIES System, a Real Time Nucleic Acid Amplification System (Class II — Special Controls, product code OOI), submitted by Luminex Corporation (Austin, US). The FDA issued a Cleared decision on April 12, 2016, 48 days after receiving the submission on February 24, 2016. This device falls under the Microbiology review panel. Regulated under 21 CFR 862.2570.

Submission Details

510(k) Number	K160517 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 24, 2016
Decision Date	April 12, 2016
Days to Decision	48 days
Submission Type	Special
Review Panel	Microbiology (MI)
Summary	Statement

Device Classification

Product Code	OOI — Real Time Nucleic Acid Amplification System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 862.2570
Definition	The System Is A Clinical Multiplex Instrument Intended To Measure And Sort Multiple Signals Generated My Multiple Probes, Intercalating Dyes, Or Other Ligands In An Assay From A Clinical Sample. Signals May Be Generated By Fluorescence Or Other Phenomena And May Be Measured Using Filters On A Photodiode Or Other Detector. It May Integrate Sample And/or Reagent Handling, Amplification, Dedicated Instrument Control, Data Acquisition Software, Raw Data Storage Mechanisms And Other Essential Hardware Components Along With The Signal Reader Unit. The System Is Used With Specific Assays To Comprise An Assay Test System.