Cleared Traditional

K132010 - VIDAS C DIFFICILE GDH (FDA 510(k) Clearance)

Class I Microbiology device.

K132010 · Biomerieux S.A. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

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.