Cleared Traditional

OSOM C. DIFFICILE TOXIN A/B TEST (K102242) - FDA 510(k) Clearance

Class I Microbiology device.

K102242 · Genzyme Corporation · Microbiology device
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Dec 2010
Decision
134d
Days
Class 1
Risk

K102242 is an FDA 510(k) clearance for the OSOM C. DIFFICILE TOXIN A/B TEST. Classified as Reagents, Clostridium Difficile Toxin (product code LLH), Class I - General Controls.

Submitted by Genzyme Corporation (Framingham, US). The FDA issued a Cleared decision on December 21, 2010 after a review of 134 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 Genzyme Corporation devices

Submission Details

510(k) Number K102242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2010
Decision Date December 21, 2010
Days to Decision 134 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
32d slower than avg
Panel avg: 102d · This submission: 134d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LLH Reagents, Clostridium Difficile Toxin
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.