Cleared Traditional

ARIES System

K151917 · Luminex Corporation · Chemistry

Oct 2015

Decision

85d

Days

Class 2

Risk

About This 510(k) Submission

K151917 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 October 6, 2015, 85 days after receiving the submission on July 13, 2015. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2570.

Submission Details

510(k) Number	K151917 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 13, 2015
Decision Date	October 06, 2015
Days to Decision	85 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
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.