Cleared Traditional

K925110 - ABBOTT IMX T4

K925110 is an FDA 510(k) clearance for ABBOTT IMX T4, manufactured by Abbott Laboratories. The device is a Class 2 Chemistry device with product code CDX cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K925110 · Abbott Laboratories · Chemistry device
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Jan 1993
Decision
109d
Days
Class 2
Risk

K925110 is an FDA 510(k) clearance for the ABBOTT IMX 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 January 26, 1993 after a review of 109 days - within the typical 510(k) review window.

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

FDA 510(k) Submission Details - K925110

510(k) Number K925110 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 1992
Decision Date January 26, 1993
Days to Decision 109 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
21d slower than avg
Panel avg: 88d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CDX Device Classification - Class 2, Special Controls

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 81
Devices cleared under the same product code (CDX) and FDA review panel - the closest regulatory comparables to K925110.
AXSYM(TM) TOTAL T4
K934384 · Abbott Laboratories · Jun 1994
TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116
K932980 · Sigma Diagnostics, Inc. · Oct 1993
STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNO
K933426 · Baxter Diagnostics, Inc. · Aug 1993
ABBOTT TDX/TDXFLX TT4
K925109 · Abbott Laboratories · Jan 1993
TECHNICON DAX SYSTEM THYROXINE (T4) METHOD
K922945 · Heraeus Kulzer, Inc. · Oct 1992
T4 EIA BEAD ASSAY
K920766 · Tech-Co, Inc. · Apr 1992