Cleared Traditional

ILLUMIGENE C. DIFFICILE, AND ILLUMIPRO-10 (K110012) - FDA 510(k) Clearance

Class I Microbiology device.

K110012 · Meridian Bioscience, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2011
Decision
52d
Days
Class 1
Risk

K110012 is an FDA 510(k) clearance for the ILLUMIGENE C. DIFFICILE, AND ILLUMIPRO-10. Classified as C. Difficile Nucleic Acid Amplification Test Assay (product code OMN), Class I - General Controls.

Submitted by Meridian Bioscience, Inc. (Cincinnati, US). The FDA issued a Cleared decision on February 24, 2011 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2660 - 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 Meridian Bioscience, Inc. devices

Submission Details

510(k) Number K110012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2011
Decision Date February 24, 2011
Days to Decision 52 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
50d faster than avg
Panel avg: 102d · This submission: 52d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code OMN C. Difficile Nucleic Acid Amplification Test Assay
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
Definition In Vitro Diagnostic Test For The Qualitative Detection Of Toxigenic Clostridium Difficile Nucleic Acids Isolated And Purified From Stool Specimens Obtained From Symptomatic Patients.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.