Cleared Traditional

K132010 - VIDAS C DIFFICILE GDH

K132010 is an FDA 510(k) clearance for VIDAS C DIFFICILE GDH, manufactured by Biomerieux S.A.. The device is a Class 1 Microbiology device with product code MCB cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K132010 · Biomerieux S.A. · Microbiology device
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Oct 2013
Decision
100d
Days
Class 1
Risk

K132010 is an FDA 510(k) clearance for the VIDAS C DIFFICILE GDH. Classified as Antigen, C. Difficile (product code MCB), Class I - General Controls.

Submitted by Biomerieux S.A. (Craponne, FR). The FDA issued a Cleared decision on October 9, 2013 after a review of 100 days - within the typical 510(k) review window.

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 Biomerieux S.A. devices

FDA 510(k) Submission Details - K132010

510(k) Number K132010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2013
Decision Date October 09, 2013
Days to Decision 100 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
2d faster than avg
Panel avg: 102d · This submission: 100d
Pathway characteristics
Predicate-based equivalence.

MCB Device Classification - Class 1, General Controls

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

All 9
Devices cleared under the same product code (MCB) and FDA review panel - the closest regulatory comparables to K132010.
IMMUNOCARD C. DIFFICILE GDH
K112048 · Meridian Bioscience, Inc. · Dec 2011
PREMIER C. DIFFICILE GDH
K110620 · Meridian Bioscience, Inc. · May 2011
C. DIFF QUIK CHEK
K053572 · Techlab, Inc. · Apr 2006
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