Cleared Traditional

K931129 - TECHLAB 1-HOUR TOX-A-TEST (FDA 510(k) Clearance)

Class I Microbiology device.

K931129 · Techlab, Inc. · Microbiology device
Sep 1993
Decision
209d
Days
Class 1
Risk

K931129 is an FDA 510(k) clearance for the TECHLAB 1-HOUR TOX-A-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 September 30, 1993 after a review of 209 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 K931129 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1993
Decision Date September 30, 1993
Days to Decision 209 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 174d · This submission: 209d
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.