Product Code: CEC FDA class 2 21 CFR 862.1695

Radioimmunoassay, Free Thyroxine

Clinical Chemistry

The Free Thyroxine Radioimmunoassay is a clinical chemistry device that uses radiolabeled antibody techniques to specifically measure free (unbound) thyroxine (free T4) in serum, a more clinically informative measure of thyroid hormone status than total T4, used in diagnosing thyroid dysfunction. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is CEC, regulated under 21 CFR 862.1695, within the Clinical Chemistry medical specialty. This device is eligible for third-party review.

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FEI Numbers

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Basic Information

Product Code: CEC
Device Class: FDA class 2
Regulation Number: 862.1695
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 92 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K240273	Access Free T4	Mar 06, 2024	Substantially Equivalent	Beckman Coulter, Inc.
K220456	Elecsys FT4 IV	Apr 07, 2023	Substantially Equivalent	Roche Diagnostics
K182423	MAGLUMI 2000 FT4	Oct 04, 2018	Substantially Equivalent	Shenzhen New Industries Biomedical Engineering Co., Ltd.
K181233	Elecsys FT4 III	Sep 18, 2018	Substantially Equivalent	Roche Diagnostics
K173122	Abbott Architect Free T4	Oct 27, 2017	Substantially Equivalent	Abbott Laboratories
K152422	FREND Free T4 Test System	Feb 17, 2016	Substantially Equivalent	Nanoentek USA, Inc.
K132058	VIDAS FT4	Jun 08, 2015	Substantially Equivalent	Biomerieux S.A.
K140859	DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4, DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT	Nov 26, 2014	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K140842	DIMENSION LOCI FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4L, DIMENSION LOCI THYROID STIMULATING HORMONE FLEX REAGENT CART	Nov 26, 2014	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K131244	ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSET	Jan 27, 2014	Substantially Equivalent	Roche Diagnostics
K132249	ADVIA CENTAUR FT4, ADVIA CENTAUR T4	Sep 13, 2013	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K121951	LIAISON FT4 LIAISON CONTROL THYROID 1 LIAISON CONTROL THYROID 2 LIAISON CONTROL THYROID 3	Apr 04, 2013	Substantially Equivalent	DiaSorin, Inc.
K123379	ABBOTT ARCHITECT FREE T4	Nov 27, 2012	Substantially Equivalent	Abbott Laboratories
K083373	IMMULITE 2000 FREE T4	Feb 02, 2009	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K080167	ACS 180 AND ADVIA CENTAUR FT4 IMMUNOASSAYS	Aug 08, 2008	Substantially Equivalent	Siemens Healthcare Diagnostics
K073604	DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD	Mar 13, 2008	Substantially Equivalent	Dade Behring, Inc.
K070708	OLYMPUS FT4-FREE THYROXINE, OLYMPUS T4- TOTAL THYROXINE, MODEL# OSR210102, OSR210104	Aug 21, 2007	Substantially Equivalent	Olympus Life & Material Science Europa GmbH (Irish
K053531	DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE AND LOCI 1 CALIBRATOR	Mar 03, 2006	Substantially Equivalent	Dade Behring, Inc.
K030329	FASTPACK FREE T4 IMMUNOASSAY	Jul 03, 2003	Substantially Equivalent	Qualigen, Inc.
K020548	FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300	Apr 05, 2002	Substantially Equivalent	Monobind
K983417	ABBOTT ARCHITECT FREE T4	Nov 20, 1998	Substantially Equivalent	Abbott Laboratories
K982954	FREE T4 MICROWELL EIA, MODEL #7019	Sep 24, 1998	Substantially Equivalent	Biomerica, Inc.
K982250	ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER	Jul 14, 1998	Substantially Equivalent	Beckman Instruments, Inc.
K981243	BIOSTRIDE FREE T4 EIA TEST KIT	Jun 29, 1998	Substantially Equivalent	Biostride Diagnostics, Inc.
K980819	BIOCIRCUITS IOS FREE THYROXINE (FT4) TEST CARTRIDGES BIOCIRCUITS IOS CONTROLS	Apr 03, 1998	Substantially Equivalent	Biocircuits Corp.
K974551	SEALITE SCIENCES, INC. AQUALITE FREE T, ASSAY	Dec 22, 1997	Substantially Equivalent	Sealite Sciences, Inc.
K971792	IMMULITE FREE T4 (2-STEP)	Jul 25, 1997	Substantially Equivalent	Diagnostic Products Corp.
K971141	FT4 METHOD FOR THE DIMENSION RXL CLINICAL CHEMISTRY SYSTEM	Apr 28, 1997	Substantially Equivalent	Dade Chemistry Systems, Inc.
K965142	VITROS IMMUNODIAGNOSTICS PRODUCTS FREE T4 REAGENT PACK (GEM.1015) FREE T4 CALIBRATORS (GEM.CO15)	Mar 18, 1997	Substantially Equivalent	Johnson & Johnson Clinical Diagnostics, Inc.
K962408	NICHOLS ADVANTAGE CHEMILUMINESCENCE FREE T4- ESTIMATE KIT	Mar 18, 1997	Substantially Equivalent	Nichols Institute Diagnostics
K962602	ACA PLUS FREE THYROXINE(FT4) METHOD	Aug 15, 1996	Substantially Equivalent	Dade Intl., Inc.
K961489	ELECSYS FT4 ASSAY	Jun 11, 1996	Substantially Equivalent	Boehringer Mannheim Corp.
K955097	AMERLITE MAB FT4 ASSAY	Dec 20, 1995	Substantially Equivalent	Kodak Clinical Diagnostics, Ltd.
K942376	COBAS CORE FREE T3 EIA	Apr 21, 1995	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K944697	AURA FLEX FT4 200 TEST PACK, FT4 CALIBRATOR PACK	Feb 22, 1995	Substantially Equivalent	Organon Teknika Corp.
K940507	OPUS FT4 TEST SYSTEM	Jul 28, 1994	Substantially Equivalent	Pb Diagnostic Systems, Inc.
K934544	AXSYM FREE THYROXINE ( FREE T4 )	Jun 21, 1994	Substantially Equivalent	Abbott Laboratories
K940482	CIBA CORNING ACS FT3 IMMUNOASSAY	Apr 26, 1994	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K932607	COBAS(R) CORE FT4 EIA	Jan 24, 1994	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K934012	FT4 RADIOIMMUNOASSAY	Nov 16, 1993	Substantially Equivalent	Immunotech S.A.
K930322	FREE THYROXINE(F T4) METHOD/TECHNICON IMMUNO 1(R)	Nov 10, 1993	Substantially Equivalent	Heraeus Kulzer, Inc.
K932912	STRATUS FREE THYROXINE (FREE T4) FLUOROMETRIC	Oct 28, 1993	Substantially Equivalent	Baxter Diagnostics, Inc.
K931704	IMMULITE FREE T4	Aug 16, 1993	Substantially Equivalent	Diagnostic Products Corp.
K931110	RADIAS FREE T4 ENZYME IMMUNOASSAY	May 20, 1993	Substantially Equivalent	Bio-Rad
K925842	BECTON DICKINSON SIMULTRAC COMPONENT SYSTEM	Apr 20, 1993	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K925649	NAT. SCREENING INSTITUTE MICRO-PLATE FREE T4 ASSAY	Mar 01, 1993	Substantially Equivalent	Solarcare Technologies Corp,Inc.
K925913	ACCESS(R) FREE T4 ASSAY	Jan 27, 1993	Substantially Equivalent	Bio-Rad Laboratories, Inc.
K925177	VIDAS FREE THYROXINE(FT4) ASSAY	Nov 30, 1992	Substantially Equivalent	Biomerieux Vitek, Inc.
K923572	VISTA FREE THYROXINE ASSAY	Nov 16, 1992	Substantially Equivalent	Syva Co.
K922713	KODAK AMERLITE MAB FT3 ASSAY	Oct 26, 1992	Substantially Equivalent	Eastman Kodak Company
K922284	ELEGANCE FT4 ELISA	Jul 10, 1992	Substantially Equivalent	Bioclone Australia Pty , Ltd.
K920247	AMERLITE MAB FT4 ASSAY	Mar 02, 1992	Substantially Equivalent	Eastman Kodak Company
K914835	LUMATAG FREE T4 CHEMILUMINESCENCE ASSAY	Dec 17, 1991	Substantially Equivalent	London Diagnostics, Inc.
K912937	SR1 FREE T4 ENZYME IMMUNOASSAY	Nov 19, 1991	Substantially Equivalent	Serono-Baker Diagnostics, Inc.
K912698	AFFINITY FREE T4 TEST SYSTEM	Oct 07, 1991	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K913493	AIA-PACK FT4	Sep 10, 1991	Substantially Equivalent	Tosoh Corp.
K911634	MICROZYME(TM) FREE T4 ENZYME IMMUNOASSAY TEST	Jun 24, 1991	Substantially Equivalent	Immunotech Corp.
K910684	CIBA CORNING ACS FT4 IMMUNOASSAY	May 01, 1991	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K904539	FLAGEN TM FREE T4	Nov 30, 1990	Substantially Equivalent	Cyberfluor, Inc.
K903384	IMX FREE T4 CALCULATION	Sep 10, 1990	Substantially Equivalent	Abbott Laboratories
K903383	TDX FREE T4 CALCULATION	Sep 10, 1990	Substantially Equivalent	Abbott Laboratories
K902834	ABBOTT IMX FREE T4	Sep 07, 1990	Substantially Equivalent	Abbott Laboratories
K900883	ENZYMUN TEST(R) FT4 (FREE THYROXINE)	May 15, 1990	Substantially Equivalent	Boehringer Mannheim Corp.
K900060	FREE T4 IMMUNOASSAY KIT	Mar 29, 1990	Substantially Equivalent	Advanced Magnetics, Inc.
K896222	FREE THYROXINE (FT4) RADIOIMMUNOASSAY KIT	Nov 17, 1989	Substantially Equivalent	Nichols Institute Diagnostics
K894605	DELFIA FREE THYROXINE (FT4) KIT	Sep 18, 1989	Substantially Equivalent	Pharmacia, Inc.
K894091	AMERLEX-MAB FT4 KIT	Aug 03, 1989	Substantially Equivalent	Amersham Corp.
K884753	MODIFIED FREE T4 RADIOIMMUNOASSAY KIT	Feb 27, 1989	Substantially Equivalent	Advanced Magnetics, Inc.
K883123	AMERLIITE FT4 ASSAY LAN.0006/2006 240/144 TEST KIT	Dec 22, 1988	Substantially Equivalent	Amersham Corp.
K883971	QLIA T UPTAKE ASSAY	Oct 25, 1988	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K874875	CHEMELIA FREE THYROXINE(FT4)/ENZYME IMMUNO. (EIA)	Mar 24, 1988	Substantially Equivalent	Boots-Celltech Diagnostics, Inc.
K870268	DIAGNOSTIC KIT FREE T3 AND FREE T4	Sep 14, 1987	Substantially Equivalent	Sclavo, Inc.
K870158	STRATUS FREE THYROXINE (FT4) FLUOR. ENZYME IMMUNO.	Mar 19, 1987	Substantially Equivalent	American Dade
K865104	IQ FTI IMMUNOASSAY	Mar 16, 1987	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K864658	IQ FREE T4 IMMUNOASSAY	Mar 12, 1987	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K864838	SIMULTRAC FREE T4[57CO]/TSH MAB[125I]	Feb 18, 1987	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K860251	AMERLEX-M T4 RIA KIT FOR SERUM AND PLASMA	Feb 11, 1986	Substantially Equivalent	Amersham Corp.
K853628	SIMULTRAC FREE T4(57CO)/TSH[125I] RADIOIMMUNOASSAY	Sep 18, 1985	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K842482	AMERLEX-M FREE T-4 RADIOIMMUNOASSAY KIT	Aug 10, 1984	Substantially Equivalent	Amersham Corp.
K840901	PHASE II FREE T4 KIT	Apr 25, 1984	Substantially Equivalent	Medical & Scientific Designs, Inc.
K832381	CORNING MAGIC SINGLE STEP FREE T4	Sep 01, 1983	Substantially Equivalent	Corning Medical & Scientific
K823264	THYROXINE ANALYSIS PRODUCTS/RADIO-FREE	Jan 12, 1983	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K823005	BIO MAG FREE T4 RADIOIMMUNOASSAY KIT	Dec 15, 1982	Substantially Equivalent	Bioclinical Group
K823144	SINGLE STEP FREE-T4 125I RADIOIMMUNO-	Nov 29, 1982	Substantially Equivalent	Corning Medical & Scientific
K822882	COAT-A-COUNT FREE THYROXINE KIT/COMPONEN	Nov 05, 1982	Substantially Equivalent	Diagnostic Products Corp.
K821241	FREE T4 RADIOIMMUNOASSAY KIT	Jun 01, 1982	Substantially Equivalent	Bioclinical Group
K813465	FREE T4 RIA TEST SET	Dec 31, 1981	Substantially Equivalent	Ventrex Laboratories, Inc.
K810231	CODE IM 2050 AMERLEX FREE T4 RIA KIT	Feb 10, 1981	Substantially Equivalent	Amersham Corp.
K781560	RIA DIAG. TEST KIT FOR INDEXING THYROX.	Oct 17, 1978	Substantially Equivalent	Nuclear Diagnostics, Inc.
K781012	RIA TEST KIT SYS. DAMON KIQUISOL FREE	Jul 27, 1978	Substantially Equivalent	Damon Corp.
K772194	IMMO PHASE FT4 ASSAY	Jan 06, 1978	Substantially Equivalent	Corning Medical & Scientific
K771236	TRIOBEAD-125 DIAGNOSTIC KIT	Aug 03, 1977	Substantially Equivalent	Abbott Laboratories