Cleared Traditional

K923463 - CLOSTRIDIUM DIFFICILE TOXIN/ANTITOXIN KIT (FDA 510(k) Clearance)

Class I Microbiology device.

K923463 · Techlab, Inc. · Microbiology device
Feb 1993
Decision
202d
Days
Class 1
Risk

K923463 is an FDA 510(k) clearance for the CLOSTRIDIUM DIFFICILE TOXIN/ANTITOXIN KIT. Classified as Reagents, Clostridium Difficile Toxin (product code LLH), Class I - General Controls.

Submitted by Techlab, Inc. (Washington, US). The FDA issued a Cleared decision on February 1, 1993 after a review of 202 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.

Submission Details

510(k) Number K923463 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1992
Decision Date February 01, 1993
Days to Decision 202 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 174d · This submission: 202d
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.