Cleared Traditional

PREMIER C. DIFFICILE GDH (K110620) - FDA 510(k) Clearance

Class I Microbiology device.

K110620 · Meridian Bioscience, Inc. · Microbiology device
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May 2011
Decision
61d
Days
Class 1
Risk

K110620 is an FDA 510(k) clearance for the PREMIER C. DIFFICILE GDH. Classified as Antigen, C. Difficile (product code MCB), Class I - General Controls.

Submitted by Meridian Bioscience, Inc. (Cincinnati, US). The FDA issued a Cleared decision on May 3, 2011 after a review of 61 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 K110620 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2011
Decision Date May 03, 2011
Days to Decision 61 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
41d faster than avg
Panel avg: 102d · This submission: 61d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MCB Antigen, C. Difficile
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
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.