Cleared Traditional

K935296 - CLOSTRIDIUM DIFFICILE TOX-B TEST (FDA 510(k) Clearance)

Class I Microbiology device.

K935296 · Techlab, Inc. · Microbiology device
Apr 1994
Decision
174d
Days
Class 1
Risk

K935296 is an FDA 510(k) clearance for the CLOSTRIDIUM DIFFICILE TOX-B TEST. 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 26, 1994 after a review of 174 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 K935296 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1993
Decision Date April 26, 1994
Days to Decision 174 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 174d · This submission: 174d
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.