Cleared Traditional

K112048 - IMMUNOCARD C. DIFFICILE GDH

K112048 is the FDA 510(k) clearance for IMMUNOCARD C. DIFFICILE GDH by Meridian Bioscience, Inc.. It is a Class 1 Microbiology device (product code MCB) cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K112048 · Meridian Bioscience, Inc. · Microbiology device
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Dec 2011
Decision
151d
Days
Class 1
Risk

K112048 is an FDA 510(k) clearance for the IMMUNOCARD 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 December 16, 2011 after a review of 151 days - an extended review 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: 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 Meridian Bioscience, Inc. devices

Submission Details

510(k) Number K112048 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2011
Decision Date December 16, 2011
Days to Decision 151 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
49d slower than avg
Panel avg: 102d · This submission: 151d
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.

Regulatory Peers - MCB Antigen, C. Difficile

Devices cleared under the same product code (MCB) and FDA review panel - the closest regulatory comparables to K112048.
TRIAGE C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DIFFICILE TOXIN A
K974881 · Biosite Incorporated · Mar 1998
CLEARVIEW C. DIFF A
K955067 · Unipath , Ltd. · Sep 1996
MERITEC C. DIFFICILE CONTROLS
K924062 · Meridian Diagnostics, Inc. · Oct 1992
CLOSTRIDIUM DIFFICILE TOXIN A ENZYME IMMUNOASSAY
K904329 · Baxter Healthcare Corp · Mar 1991
MERITEC(TM) - C. DIFFICILE LATEX TEST SYSTEM
K895915 · Meridian Diagnostics, Inc. · Mar 1990