Cleared Traditional

K171441 - 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 is an FDA 510(k) clearance for ARIES C. difficile Assay Complete Kit, manufactured by Luminex Corporation. The device is a Class 2 Microbiology device with product code OZN cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K171441 · Luminex Corporation · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2017
Decision
66d
Days
Class 2
Risk

K171441 is an FDA 510(k) clearance for the ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File.... Classified as C. Difficile Toxin Gene Amplification Assay (product code OZN), Class II - Special Controls.

Submitted by Luminex Corporation (Austin, US). The FDA issued a Cleared decision on July 21, 2017 after a review of 66 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Luminex Corporation devices

FDA 510(k) Submission Details - K171441

510(k) Number K171441 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 102d · This submission: 66d
Pathway characteristics
Predicate-based equivalence.

OZN Device Classification - Class 2, Special Controls

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Microbiology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT02497417 Completed Observational Industry-sponsored

A Multi-Site Clinical Evaluation of the ARIES Clostridium Difficile Assay in Symptomatic Patients

1021
Patients (actual)
4
Sites
Condition studied Gastroenteritis; Infectious Colitis
Eligibility All sexes
Principal investigator Ronald Dunn
Sponsor Luminex Corporation (industry)
Started 2016-10-01 → Primary completion 2017-02-01
Primary outcome
Diagnostic accuracy will be a composite expressed in terms of clinical sensitivity (or positive agreement) and specificity (or negative agreement).
Study completed - no results published. This trial concluded in 2017 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

Regulatory Peers - OZN C. Difficile Toxin Gene Amplification Assay

All 17
Devices cleared under the same product code (OZN) and FDA review panel - the closest regulatory comparables to K171441.
cobas Cdiff nucleic acid test for use on the cobas Liat System
K210385 · Roche Molecular Systems, Inc. · Sep 2021
GenePOC CDiff
K172569 · Genepoc, Inc. · Nov 2017
cobas Cdiff Nucleic acid test for use on the cobas Liat System
K171770 · Roche Molecular Systems, Inc. · Sep 2017
Solana C. difficile Assay
K170491 · Quidel Corporation · May 2017
Simplexa C. difficile Direct
K163085 · Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC · Feb 2017
cobas Cdiff Test
K142422 · Roche Molecular Systems, Inc. · May 2015