Cleared Traditional

ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit

K172402 · Luminex Corporation · Microbiology

Oct 2017

Decision

82d

Days

Class 2

Risk

About This 510(k) Submission

K172402 is an FDA 510(k) clearance for the ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit, a Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System (Class II — Special Controls, product code PGX), submitted by Luminex Corporation (Austin, US). The FDA issued a Cleared decision on October 30, 2017, 82 days after receiving the submission on August 9, 2017. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2680.

Submission Details

510(k) Number	K172402 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 09, 2017
Decision Date	October 30, 2017
Days to Decision	82 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	PGX — Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.2680
Definition	An In Vitro Diagnostic Test For The Detection Of Group A, C And G Beta Hemolytic Streptococcus In Throat Swab Specimens From Symptomatic Patients.