Cleared Traditional

K924979 - IMMUNOCARD(TM) C. DIFFICILE

K924979 is an FDA 510(k) clearance for IMMUNOCARD(TM) C. DIFFICILE, manufactured by Meridian Diagnostics, Inc.. The device is a Class 1 Microbiology device with product code LLH cleared through the Traditional 510(k) pathway after a 117-day FDA review.

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

FDA 510(k) Submission Details - K924979

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.

LLH Device Classification - Class 1, General Controls

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.

Regulatory Peers - LLH Reagents, Clostridium Difficile Toxin

All 35
Devices cleared under the same product code (LLH) and FDA review panel - the closest regulatory comparables to K924979.
CULTURETTE BRAND TOXIN CD TEST
K925329 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1993
CLOSTRIDIUM DIFFICILE TOXIN/ANTITOXIN KIT
K923463 · Techlab, Inc. · Feb 1993
PREMIER C. DIFFICILE, MODIFICATION
K926442 · Meridian Diagnostics, Inc. · Jan 1993
PREMIER C. DIFFICILE TOXIN A CONTROLS
K924136 · Meridian Diagnostics, Inc. · Oct 1992
CLOSTRIDIUM DIFFICILE TOX-A-TEST
K914902 · Techlab, Inc. · Mar 1992
VIDAS CLOSTRIDIUM DIFFICILE TOXIN A (CDA) ASSAY
K905211 · Vitek Systems, Inc. · Oct 1991