Cleared Traditional

K923463 - CLOSTRIDIUM DIFFICILE TOXIN/ANTITOXIN KIT

K923463 is the FDA 510(k) clearance for CLOSTRIDIUM DIFFICILE TOXIN/ANTITOXIN KIT by Techlab, Inc.. It is a Class 1 Microbiology device (product code LLH) cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K923463 · Techlab, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Techlab, Inc. devices

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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d slower than avg
Panel avg: 102d · 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.

Regulatory Peers - LLH Reagents, Clostridium Difficile Toxin

All 14
Devices cleared under the same product code (LLH) and FDA review panel - the closest regulatory comparables to K923463.
VIDAS C. DIFFICILE TOXIN A II ASSAY
K964887 · Biomerieux Vitek, Inc. · Apr 1997
IMMUNOCARD TOXIN A
K955859 · Meridian Diagnostics, Inc. · Apr 1996
CULTURETTE BRAND TOXIN CD TEST
K925329 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1993
PREMIER C. DIFFICILE, MODIFICATION
K926442 · Meridian Diagnostics, Inc. · Jan 1993
IMMUNOCARD(TM) C. DIFFICILE
K924979 · Meridian Diagnostics, Inc. · Jan 1993
PREMIER C. DIFFICILE TOXIN A CONTROLS
K924136 · Meridian Diagnostics, Inc. · Oct 1992