Cleared Traditional

K923463 - CLOSTRIDIUM DIFFICILE TOXIN/ANTITOXIN KIT

K923463 is an FDA 510(k) clearance for CLOSTRIDIUM DIFFICILE TOXIN/ANTITOXIN KIT, manufactured by Techlab, Inc.. The device is a Class 1 Microbiology device with 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

FDA 510(k) Submission Details - K923463

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d slower than avg
Panel avg: 102d · This submission: 202d
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 K923463.
CLOSTRIDIUM DIFFICILE TOX-B TEST
K935296 · Techlab, Inc. · Apr 1994
TECHLAB 1-HOUR TOX-A-TEST
K931129 · Techlab, Inc. · Sep 1993
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