Cleared Traditional

K030404 - C. DIFFICILE TOX A/B II

K030404 is the FDA 510(k) clearance for C. DIFFICILE TOX A/B II by Techlab, Inc.. It is a Class 1 Microbiology device (product code LLH) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K030404 · Techlab, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2003
Decision
77d
Days
Class 1
Risk

K030404 is an FDA 510(k) clearance for the C. DIFFICILE TOX A/B II. Classified as Reagents, Clostridium Difficile Toxin (product code LLH), Class I - General Controls.

Submitted by Techlab, Inc. (Blacksburg, US). The FDA issued a Cleared decision on April 24, 2003 after a review of 77 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Techlab, Inc. devices

Submission Details

510(k) Number K030404 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2003
Decision Date April 24, 2003
Days to Decision 77 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
25d faster than avg
Panel avg: 102d · This submission: 77d
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 29
Devices cleared under the same product code (LLH) and FDA review panel - the closest regulatory comparables to K030404.
IMMUNOCARD TOXINS A & B, MODEL 712050
K041003 · Meridian Bioscience, Inc. · Aug 2004
C. DIFF CHEK - 30
K030991 · Techlab, Inc. · Jul 2003
C. DIFF CHEK - 60
K030992 · Techlab, Inc. · Jul 2003
C. DIFFICILE TOX A/B II
K003306 · Techlab, Inc. · Nov 2000
PREMIER TOXINS A&B, MODEL 616096
K993914 · Meridian Diagnostics, Inc. · Dec 1999
COLORPAC TOXIN A
K980185 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1998