Cleared Traditional

ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit

K171441 · Luminex Corporation · Microbiology

Jul 2017

Decision

66d

Days

Class 2

Risk

About This 510(k) Submission

K171441 is an FDA 510(k) clearance for the ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit, a C. Difficile Toxin Gene Amplification Assay (Class II — Special Controls, product code OZN), submitted by Luminex Corporation (Austin, US). The FDA issued a Cleared decision on July 21, 2017, 66 days after receiving the submission on May 16, 2017. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3130.

Submission Details

510(k) Number	K171441 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 16, 2017
Decision Date	July 21, 2017
Days to Decision	66 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	OZN — C. Difficile Toxin Gene Amplification Assay
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3130
Definition	Amplification Assay For The Detection Of C. Difficile Toxin Genes From Stool Specimens Of Symptomatic Patients.