Cleared Traditional

FT4 RADIOIMMUNOASSAY (K934012) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K934012 · Immunotech S.A. · Chemistry device
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Nov 1993
Decision
90d
Days
Class 2
Risk

K934012 is an FDA 510(k) clearance for the FT4 RADIOIMMUNOASSAY. Classified as Radioimmunoassay, Free Thyroxine (product code CEC), Class II - Special Controls.

Submitted by Immunotech S.A. (France, FR). The FDA issued a Cleared decision on November 16, 1993 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1695 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Immunotech S.A. devices

Submission Details

510(k) Number K934012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1993
Decision Date November 16, 1993
Days to Decision 90 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 88d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CEC Radioimmunoassay, Free Thyroxine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1695
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CEC Radioimmunoassay, Free Thyroxine

All 35
Devices cleared under the same product code (CEC) and FDA review panel - the closest regulatory comparables to K934012.
COBAS CORE FREE T3 EIA
K942376 · Roche Diagnostic Systems, Inc. · Apr 1995
AXSYM FREE THYROXINE ( FREE T4 )
K934544 · Abbott Laboratories · Jun 1994
COBAS(R) CORE FT4 EIA
K932607 · Roche Diagnostic Systems, Inc. · Jan 1994
IMMULITE FREE T4
K931704 · Diagnostic Products Corp. · Aug 1993
RADIAS FREE T4 ENZYME IMMUNOASSAY
K931110 · Bio-Rad · May 1993
BECTON DICKINSON SIMULTRAC COMPONENT SYSTEM
K925842 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1993