Cleared Traditional

K033479 - PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY (FDA 510(k) Clearance)

Class I Microbiology device.

K033479 · Remel, Inc. · Microbiology device
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Feb 2004
Decision
115d
Days
Class 1
Risk

K033479 is an FDA 510(k) clearance for the PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY. Classified as Reagents, Clostridium Difficile Toxin (product code LLH), Class I - General Controls.

Submitted by Remel, Inc. (Ramsey, US). The FDA issued a Cleared decision on February 26, 2004 after a review of 115 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 Remel, Inc. devices

Submission Details

510(k) Number K033479 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 2003
Decision Date February 26, 2004
Days to Decision 115 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
13d slower than avg
Panel avg: 102d · This submission: 115d
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.