Cleared Traditional

AXSYM(TM) TOTAL T4 (K934384) - FDA 510(k) Clearance

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

K934384 · Abbott Laboratories · Chemistry device
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Jun 1994
Decision
293d
Days
Class 2
Risk

K934384 is an FDA 510(k) clearance for the AXSYM(TM) TOTAL T4. Classified as Radioimmunoassay, Total Thyroxine (product code CDX), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on June 21, 1994 after a review of 293 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1700 - 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 Abbott Laboratories devices

Submission Details

510(k) Number K934384 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1993
Decision Date June 21, 1994
Days to Decision 293 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
205d slower than avg
Panel avg: 88d · This submission: 293d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CDX Radioimmunoassay, Total Thyroxine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1700
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 - CDX Radioimmunoassay, Total Thyroxine

All 40
Devices cleared under the same product code (CDX) and FDA review panel - the closest regulatory comparables to K934384.
ELECSYS T4 ASSAY
K961490 · Boehringer Mannheim Corp. · Jun 1996
TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116
K932980 · Sigma Diagnostics, Inc. · Oct 1993
ABBOTT IMX T4
K925110 · Abbott Laboratories · Jan 1993
ABBOTT TDX/TDXFLX TT4
K925109 · Abbott Laboratories · Jan 1993
TECHNICON DAX SYSTEM THYROXINE (T4) METHOD
K922945 · Heraeus Kulzer, Inc. · Oct 1992
MILENIA TOTAL T4, CATALOG: MKT41,5
K912541 · Diagnostic Products Corp. · Aug 1991