Cleared Traditional

K904329 - CLOSTRIDIUM DIFFICILE TOXIN A ENZYME IMMUNOASSAY

K904329 is an FDA 510(k) clearance for CLOSTRIDIUM DIFFICILE TOXIN A ENZYME IM..., manufactured by Baxter Healthcare Corp. The device is a Class 1 Microbiology device with product code MCB cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K904329 · Baxter Healthcare Corp · Microbiology device
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Mar 1991
Decision
173d
Days
Class 1
Risk

K904329 is an FDA 510(k) clearance for the CLOSTRIDIUM DIFFICILE TOXIN A ENZYME IMMUNOASSAY. Classified as Antigen, C. Difficile (product code MCB), Class I - General Controls.

Submitted by Baxter Healthcare Corp (Bellevue, US). The FDA issued a Cleared decision on March 12, 1991 after a review of 173 days - an extended review cycle.

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 Baxter Healthcare Corp devices

FDA 510(k) Submission Details - K904329

510(k) Number K904329 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1990
Decision Date March 12, 1991
Days to Decision 173 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d slower than avg
Panel avg: 102d · This submission: 173d
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 K904329.
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
MERITEC(TM) - C. DIFFICILE LATEX TEST SYSTEM
K895915 · Meridian Diagnostics, Inc. · Mar 1990
CYTOTOXICITY ASSAY FOR CLOSTRIDIUM-
K833447 · Bartels Immunodiagnostic Supplies, Inc. · May 1984