Cleared Special

ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD)

K161495 · Luminex Corporation · Microbiology
Jun 2016
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K161495 is an FDA 510(k) clearance for the ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD), 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 June 30, 2016, 29 days after receiving the submission on June 1, 2016. This device falls under the Microbiology review panel. Regulated under 21 CFR 862.2570.

Submission Details

510(k) Number K161495 FDA.gov
FDA Decision Cleared SESE
Date Received June 01, 2016
Decision Date June 30, 2016
Days to Decision 29 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.