Cleared Traditional

K924979 - IMMUNOCARD(TM) C. DIFFICILE (FDA 510(k) Clearance)

Class I Microbiology device.

K924979 · Meridian Diagnostics, Inc. · Microbiology device
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Jan 1993
Decision
117d
Days
Class 1
Risk

K924979 is an FDA 510(k) clearance for the IMMUNOCARD(TM) C. DIFFICILE. Classified as Reagents, Clostridium Difficile Toxin (product code LLH), Class I - General Controls.

Submitted by Meridian Diagnostics, Inc. (Cincinnati, US). The FDA issued a Cleared decision on January 26, 1993 after a review of 117 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 Meridian Diagnostics, Inc. devices

Submission Details

510(k) Number K924979 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1992
Decision Date January 26, 1993
Days to Decision 117 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
15d slower than avg
Panel avg: 102d · This submission: 117d
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.