Cleared Special

K003306 - C. DIFFICILE TOX A/B II

K003306 is an FDA 510(k) clearance for C. DIFFICILE TOX A/B II, manufactured by Techlab, Inc.. The device is a Class 1 Microbiology device with product code LLH cleared through the Special 510(k) pathway after a 33-day FDA review.

K003306 · Techlab, Inc. · Microbiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2000
Decision
33d
Days
Class 1
Risk

K003306 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 November 22, 2000 after a review of 33 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K003306

510(k) Number K003306 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 2000
Decision Date November 22, 2000
Days to Decision 33 days
Submission Type Special
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
69d faster than avg
Panel avg: 102d · This submission: 33d
Pathway characteristics
Modification to existing cleared device.

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 41
Devices cleared under the same product code (LLH) and FDA review panel - the closest regulatory comparables to K003306.
C. DIFF CHEK - 30
K030991 · Techlab, Inc. · Jul 2003
C. DIFF CHEK - 60
K030992 · Techlab, Inc. · Jul 2003
C. DIFFICILE TOX A/B II
K030404 · Techlab, Inc. · Apr 2003
PREMIER TOXINS A&B, MODEL 616096
K993914 · Meridian Diagnostics, Inc. · Dec 1999
CDTOX A OIA
K991829 · Biostar, Inc. · Nov 1999
PRIMA SYSTEM - OLD, BARTELS ELISA - NEW
K990664 · Intracel Corp. · Mar 1999
K003306 · C. DIFFICILE TOX A/B II
Download PDF FDA Summary Techlab, Inc.