Cleared Traditional

SHIGA TOXIN CHEK (K121411) - FDA 510(k) Clearance

Class I Microbiology device.

K121411 · Techlab Inc., Corporate Research Center · Microbiology device
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Oct 2012
Decision
144d
Days
Class 1
Risk

K121411 is an FDA 510(k) clearance for the SHIGA TOXIN CHEK. Classified as Antigens, All Types, Escherichia Coli (product code GMZ), Class I - General Controls.

Submitted by Techlab Inc., Corporate Research Center (Blacksburg, US). The FDA issued a Cleared decision on October 2, 2012 after a review of 144 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3255 - 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., Corporate Research Center devices

Submission Details

510(k) Number K121411 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2012
Decision Date October 02, 2012
Days to Decision 144 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 102d · This submission: 144d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GMZ Antigens, All Types, Escherichia Coli
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3255
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.