Cleared Traditional

K133936 - ARTUS C. DIFFICILE QS-RGQ MDX KIT (FDA 510(k) Clearance)

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K133936 · QIAGEN GmbH · Microbiology device
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Apr 2014
Decision
102d
Days
Class 2
Risk

K133936 is an FDA 510(k) clearance for the ARTUS C. DIFFICILE QS-RGQ MDX KIT. Classified as C. Difficile Toxin Gene Amplification Assay (product code OZN), Class II - Special Controls.

Submitted by QIAGEN GmbH (Gaithersburg, US). The FDA issued a Cleared decision on April 4, 2014 after a review of 102 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3130 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all QIAGEN GmbH devices

Submission Details

510(k) Number K133936 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 102d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OZN C. Difficile Toxin Gene Amplification Assay
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - OZN C. Difficile Toxin Gene Amplification Assay

All 16
Devices cleared under the same product code (OZN) and FDA review panel - the closest regulatory comparables to K133936.
Xpert C. difficile/Epi
K243730 · Cepheid · Feb 2025
Great Basin Toxigenic C. difficile Direct Test (CDF2)
K232092 · Vela Operations USA · Nov 2023
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K212427 · Roche Molecular Systems, Inc. · Oct 2021
cobas Cdiff nucleic acid test for use on the cobas Liat System
K210385 · Roche Molecular Systems, Inc. · Sep 2021