Cleared Traditional

ARTUS C. DIFFICILE QS-RGQ MDX KIT

K133936 · QIAGEN GmbH · Microbiology

Apr 2014

Decision

102d

Days

Class 2

Risk

About This 510(k) Submission

K133936 is an FDA 510(k) clearance for the ARTUS C. DIFFICILE QS-RGQ MDX KIT, a C. Difficile Toxin Gene Amplification Assay (Class II — Special Controls, product code OZN), submitted by QIAGEN GmbH (Gaithersburg, US). The FDA issued a Cleared decision on April 4, 2014, 102 days after receiving the submission on December 23, 2013. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3130.

Submission Details

510(k) Number	K133936 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 23, 2013
Decision Date	April 04, 2014
Days to Decision	102 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.