Product Code: CDX FDA class 2 21 CFR 862.1700

Radioimmunoassay, Total Thyroxine

Clinical Chemistry

The Total Thyroxine Radioimmunoassay is a clinical chemistry device that uses radiolabeled antibody competition to measure total thyroxine (T4) levels in serum, providing essential data for diagnosing and monitoring thyroid function disorders including hypothyroidism and hyperthyroidism. It is classified as FDA Class 2 (moderate risk), though it is exempt from 510(k) premarket notification. The product code is CDX, regulated under 21 CFR 862.1700, within the Clinical Chemistry medical specialty. No special flags apply to this device.

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510(k)s

121

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: CDX
Device Class: FDA class 2
Regulation Number: 862.1700
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 121 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K961490	ELECSYS T4 ASSAY	Jun 13, 1996	Substantially Equivalent	Boehringer Mannheim Corp.
K954312	ACTIVE THYROXINE RIA	Oct 07, 1995	Substantially Equivalent	Diagnostic Systems Laboratories, Inc.
K943416	DELFIA NEONATAL THYROXINE KIT	Mar 10, 1995	Substantially Equivalent	Wallac OY
K934384	AXSYM(TM) TOTAL T4	Jun 21, 1994	Substantially Equivalent	Abbott Laboratories
K932980	TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116	Oct 18, 1993	Substantially Equivalent	Sigma Diagnostics, Inc.
K933426	STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNO	Aug 26, 1993	Substantially Equivalent	Baxter Diagnostics, Inc.
K931295	IQ TT4 ASSAY	Jul 20, 1993	Substantially Equivalent	Becton Dickinson Advanced Diagnostics
K926563	AUTOBEAD(TM) T4 ENZYME IMMUNOASSAY TEST KIT	Mar 18, 1993	Substantially Equivalent	Bio-Chem Laboratory Systems, Inc.
K925110	ABBOTT IMX T4	Jan 26, 1993	Substantially Equivalent	Abbott Laboratories
K925109	ABBOTT TDX/TDXFLX TT4	Jan 04, 1993	Substantially Equivalent	Abbott Laboratories
K922945	TECHNICON DAX SYSTEM THYROXINE (T4) METHOD	Oct 14, 1992	Substantially Equivalent	Heraeus Kulzer, Inc.
K921935	THYROXINE (T4) COATED TUBE RIA	Jul 07, 1992	Substantially Equivalent	Monobind
K920766	T4 EIA BEAD ASSAY	Apr 17, 1992	Substantially Equivalent	Tech-Co, Inc.
K915235	CLINICAL ASSAYS GAMMA COAT FREE T4 RADIOIMM. KIT	Jan 28, 1992	Substantially Equivalent	Incstar Corp.
K912541	MILENIA TOTAL T4, CATALOG: MKT41,5	Aug 12, 1991	Substantially Equivalent	Diagnostic Products Corp.
K911985	LUMATAG T4 CHEMILUMINESCENCE ASSAY	Aug 02, 1991	Substantially Equivalent	London Diagnostics, Inc.
K904816	THYROXINE MONOCLONAL ANTIBODY SOLID PHASE RADIOIMM	Jan 17, 1991	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K905532	CIBA CORNING ACS T4 IMMUNOASSAY	Jan 15, 1991	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K902922	MICROZYME T4 ENZYME IMMUNOASSAY KIT	Jul 27, 1990	Substantially Equivalent	Immunotech Corp.
K901475	CLINICAL ASSAYS(TM) GAMMACOAT(TM) M [125I] T4	Jun 20, 1990	Substantially Equivalent	Baxter Healthcare Corp
K901939	NEOCOAT T4	May 31, 1990	Substantially Equivalent	Neometrics, Inc.
K894575	TECHNICON RA SYSTEM THYROXINE T4 METHOD	Oct 04, 1989	Substantially Equivalent	Technicon Instruments Corp.
K883559	DELFIA THYROXINE (T4) KIT	Dec 14, 1988	Substantially Equivalent	Pharmacia, Inc.
K874623	FIAGEN(TM) THYROXINE (T4), CATALOGUE #101-101	Feb 16, 1988	Substantially Equivalent	Cyberfluor, Inc.
K875081	IMMPULSE T4 ASSAY REAGENTS	Feb 11, 1988	Substantially Equivalent	Sclavo, Inc.
K872286	CIBA CORNING MAGIC LITE FT4 IMMUNOASSAY	Jul 21, 1987	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K871303	DELFIA(TM) THYROXINE (T4) KIT	Jun 17, 1987	Substantially Equivalent	Lkb Instruments, Inc.
K871008	MICROMEDIC NEONATAL T4 KIT	May 26, 1987	Substantially Equivalent	Micromedic Systems
K870965	CIBA CORNING MAGIC(R) LITE T4 IMMUNOASSAY	May 14, 1987	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K870573	T4 NO SPIN(TM) COATED TUBE RADIOIMMUNOASSAY KIT	Apr 22, 1987	Substantially Equivalent	Cambridge Medical Technology
K864560	IQ T4 IMMUNOASSAY	Dec 16, 1986	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K861320	MMS T4 RIA KIT	Apr 24, 1986	Substantially Equivalent	Micromedic Systems
K860421	STRAT TOTAL THYROXINE FLUOROMET ENZYME IMMUNOASSAY	Feb 11, 1986	Substantially Equivalent	American Dade
K854798	T-4 RIASSAY	Jan 15, 1986	Substantially Equivalent	Ria Diagnostics
K854324	PANCOAT T4 COATED TUBE RADIOIMMUNOASSAY KIT	Dec 05, 1985	Substantially Equivalent	Pantex, Div. Bio-Analysis, Inc.
K840852	IMMPULSE T4 ASSAY REAGENTS	Apr 18, 1984	Substantially Equivalent	Paragon Diagnostics, Inc.
K834023	BIO-SCIENCE LABORATORIES T4 REAGENT	Jan 24, 1984	Substantially Equivalent	Biosan Laboratories, Inc.
K833850	T4 RIA	Jan 18, 1984	Substantially Equivalent	Syncor Intl. Corp.
K833745	RIACOAT T-4	Jan 04, 1984	Substantially Equivalent	Immuno Assay Corp.
K832468	T4-RIA SINGLE REAGENT	Sep 12, 1983	Substantially Equivalent	Fairlake Laboratories
K831533	MAGIC T4 125I RADIOIMMUNOASSAY	Jun 30, 1983	Substantially Equivalent	Corning Medical & Scientific
K831107	COAT-A-COUNT NEONATAL T4 KIT RIA KIT	May 18, 1983	Substantially Equivalent	Diagnostic Products Corp.
K830642	PHASE THYROXINE RADIOIMMUNOASSAY KIT	Apr 05, 1983	Substantially Equivalent	Medical & Scientific Designs, Inc.
K823265	MONOCLONAL ANTIBODY T4 RADIO-KIT	Dec 09, 1982	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K823053	NML-TETRA-TUBE RIA	Nov 10, 1982	Substantially Equivalent	Nuclear Medical Laboratories, Inc.
K823004	BIO MAG TOTAL T4 RADIOIMMUNOASSAY KIT	Nov 05, 1982	Substantially Equivalent	Bioclinical Group
K822399	LEECO T4 QUANT DIAGNOSTICS TEST KIT	Sep 13, 1982	Substantially Equivalent	Leeco Diagnostics, Inc.
K821554	ZETAPHASE T4 RADIOIMMUNOASSAY DIAG. KIT	Jun 25, 1982	Substantially Equivalent	Amf Biological and Diagnostics Co.
K820725	SPAC T4 RIA TEST KIT	Jun 01, 1982	Substantially Equivalent	Mallinckrodt Critical Care
K821141	ENDAB T4 ENZYME IMMUNOASSAY KIT	May 13, 1982	Substantially Equivalent	Immunotech Corp.
K821101	TOTAL RADIOIMMUNOASSAY KIT	May 05, 1982	Substantially Equivalent	Bioclinical Group
K820886	THYROXINE T4 KIT	Apr 16, 1982	Substantially Equivalent	Pcl-Ria, Inc.
K811787	QUANTAPHASE T-4 RIA	Jul 10, 1981	Substantially Equivalent	Bio-Rad
K811315	COAT-A-COUNT T4 RIA KIT	May 27, 1981	Substantially Equivalent	Diagnostic Products Corp.
K811070	125 I-T4 RIA TEST KIT	Apr 29, 1981	Substantially Equivalent	Intl. Immunoassay Laboratories, Inc.
K810811	T4 RIA KIT	Apr 07, 1981	Substantially Equivalent	Immuno Assay Corp.
K803046	IMMU-TRACE T4 RIA PROCEDURE	Jan 02, 1981	Substantially Equivalent	American Dade
K802573	SERUM T4 BY ENZYME IMMUNOASSAY	Nov 24, 1980	Substantially Equivalent	Worthington Diagnostic Systems
K802469	T4 RADIOIMMUNOASSAY KIT	Nov 12, 1980	Substantially Equivalent	American Diagnostic Corp.
K802456	T4-SQUIBB RIA KIT	Oct 31, 1980	Substantially Equivalent	E. R. Squibb & Sons, Inc.
K801105	THYROXINE RADIOIMMUNOASSAY KIT	Jun 09, 1980	Substantially Equivalent	Calbiochem-Behring Corp.
K800385	ANALYTE T4-THYROXINE	Mar 19, 1980	Substantially Equivalent	Technicon Instruments Corp.
K800203	RIA PHASE T4	Mar 19, 1980	Substantially Equivalent	Boehringer Mannheim Corp.
K800300	AMERLEX T-4 RIA KIT	Mar 05, 1980	Substantially Equivalent	Amersham Corp.
K800187	EMC-M-175, THYROXINE - 100 TUBES	Feb 13, 1980	Substantially Equivalent	Endocrine-Metabolic Center
K800169	AMES RIALYZE - CHROMATOGRAPHY TUBES	Feb 13, 1980	Substantially Equivalent	Miles Laboratories, Inc.
K792599	TIPSEP-T4(RIA) T4 RADIOIMMUNOASSAY	Jan 16, 1980	Substantially Equivalent	Nuclear Diagnostics, Inc.
K792188	TETRABEAD - 125 T4 SOLID PHASE DIAG. KIT	Nov 27, 1979	Substantially Equivalent	Abbott Laboratories
K791664	IMMUCHEM COVALENT COAT SOLID PHASE ASSAY	Sep 27, 1979	Substantially Equivalent	Immuchem Corp.
K791368	VENTRE/SEP T4 TEST SET	Sep 17, 1979	Substantially Equivalent	Ventrex Laboratories, Inc.
K791231	DAC-CEL T4	Sep 04, 1979	Substantially Equivalent	Burroughs Wellcome Co.
K790576	QUANTIMUNE T-4 FIA	Jul 30, 1979	Substantially Equivalent	Bio-Rad
K790907	AUTOPAK TEST DELIVERY SYSTEM	Jun 27, 1979	Substantially Equivalent	Micromedic Systems
K790800	CENTRIA T4 RIA TEST SET	Jun 15, 1979	Substantially Equivalent	Ventrex Laboratories, Inc.
K790665	NEONATAL TY AUTOPAK TEST DELIVERY SYSTEM	May 15, 1979	Substantially Equivalent	Micromedic Systems
K790495	THYROXINE RIA KIT	May 03, 1979	Substantially Equivalent	Technia Diagnostics , Ltd.
K790477	TY RIA KIT, AUTOMATED ASSAY SYSTEM	Apr 26, 1979	Substantially Equivalent	E. R. Squibb & Sons, Inc.
K782109	RIA KIT, GAMMACOAT	Jan 26, 1979	Substantially Equivalent	Clinical Assays, Inc.
K782103	RIA KIT, NEONATAL T4	Jan 17, 1979	Substantially Equivalent	Serono Laboratories, Inc.
K781222	ACCUSCREEN T4	Nov 08, 1978	Substantially Equivalent	Neometrics, Inc.
K781483	ORTHO*T-4 RIA (PEG) KIT	Sep 27, 1978	Substantially Equivalent	Ortho Diagnostics, Inc.
K781235	IV VITRO GAMMADAB T4 RIA KIT	Aug 14, 1978	Substantially Equivalent	Clinical Assays, Inc.
K781182	MICRO THYROXINE REAGENT SYSTEM	Aug 14, 1978	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K781181	CLINIRIA TOTAL T-4 (RIA) TEST	Aug 14, 1978	Substantially Equivalent	Miles Laboratories, Inc.
K780854	IN VITRO NEONATAL T4	Jul 27, 1978	Substantially Equivalent	Clinical Assays, Inc.
K780707	T4-RIA KIT	Jun 14, 1978	Substantially Equivalent	Clinical Bioresearch
K780672	125 I-T4 RIA REAGENT	Jun 06, 1978	Substantially Equivalent	Radioimmunoassay, Inc.
K780639	EMIT CENTRIFICHEM THYROXINE ASSAY	May 03, 1978	Substantially Equivalent	Syva Co.
K780644	RADIOASSAY FOR TOTAL SERUM THYROXINE	Apr 28, 1978	Substantially Equivalent	Nuclear Diagnostics, Inc.
K780401	THYRO-ZYME-T4 ASSAY KIT	Apr 24, 1978	Substantially Equivalent	Coulter Electronics, Inc.
K780308	OREIA-T4	Apr 12, 1978	Substantially Equivalent	Organon, Inc.
K780423	STIKSEP-T4 RIA KIT	Mar 30, 1978	Substantially Equivalent	Nuclear Diagnostics, Inc.
K780121	REAGENTS, MANUEAL, ASSAY, THYROXINE	Mar 17, 1978	Substantially Equivalent	Syva Co.
K780219	ANALYSIS SYS., EMIT MAN. THYROXINE ASSAY	Mar 03, 1978	Substantially Equivalent	Syva Co.
K780050	THYROXINE STDS. IN HUMAN SERUM	Feb 13, 1978	Substantially Equivalent	Pcl-Ria, Inc.
K772330	T4 RIA KIT	Jan 12, 1978	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K771415	RIA FOR SERUM THYROXINE	Jan 05, 1978	Substantially Equivalent	Clinical Immuno-Diagnostics
K772170	EMIT CENTRIFICHEM THYROXINE ASSAY	Dec 22, 1977	Substantially Equivalent	Syva Co.
K771609	PEDIATRIC THYROXINE TEST SYS. T4	Dec 20, 1977	Substantially Equivalent	Corning Medical & Scientific
K772096	IN VITRO DIAGNOSTIC REAGENT	Nov 22, 1977	Substantially Equivalent	Pcl-Ria, Inc.
K772064	THYRODOT-4 ANTISERA LYOPHOLIZED	Nov 14, 1977	Substantially Equivalent	Medcom Diagnostics, Inc.
K772014	AMES T-4 STRIP TEST	Nov 02, 1977	Substantially Equivalent	Miles Laboratories, Inc.
K771414	T4 BY RIA DIAG. KIT	Sep 22, 1977	Substantially Equivalent	Biomedical Labs., Inc.
K771606	IMMUNOSPOT NEONATAL T4 TEST	Sep 15, 1977	Substantially Equivalent	Meloy Laboratories, Inc.
K771221	T4 RIA TEST SYSTEM	Aug 04, 1977	Substantially Equivalent	Monobind
K771309	RIA FOR TOTAL THYROXINE	Aug 03, 1977	Substantially Equivalent	Abbott Laboratories
K771135	QUANTIMUNE NEONATAL & THYROXINE RIA	Jul 14, 1977	Substantially Equivalent	Bio-Rad
K770733	REAGENT SYSTEM, THYROXINE, ARIA	Jun 24, 1977	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K770940	TOTAL THYROXINE (RIA) REAGENT SET	Jun 22, 1977	Substantially Equivalent	The Dow Chemical Co.
K770737	REAGENT SET, T-4, CPB	Jun 22, 1977	Substantially Equivalent	G.D. Searle and Co.
K770676	T-4 RIA REAGENT SET	May 20, 1977	Substantially Equivalent	G.D. Searle and Co.
K770726	RIA KIT, T4 CLASP	Apr 28, 1977	Substantially Equivalent	Squibb & Sons, Inc.
K770474	THYROSCREEN TM T4 DIAGNOSTIC KIT	Apr 28, 1977	Substantially Equivalent	Abbott Laboratories
K761272	CENTRIA T4 RIA	Mar 16, 1977	Substantially Equivalent	Clinical Diagnostics, Inc.
K770241	NEONATAL T4 RIA KIT	Feb 14, 1977	Substantially Equivalent	Diagnostic Products Corp.
K770156	SPAC TM T4 RIA KIT	Feb 07, 1977	Substantially Equivalent	Mallinckrodt Critical Care
K761282	DATA-TOPE T4 RIA PROCEDURE	Dec 30, 1976	Substantially Equivalent	Dade, Baxter Travenol Diagnostics, Inc.
K760572	SERALUTE	Nov 23, 1976	Substantially Equivalent	Miles Laboratories, Inc.
K760227	RADIOIMMUNOASSAY	Jul 26, 1976	Substantially Equivalent	Kallestad Laboratories, Inc.
K760135	TEST, RA, QUANTA-COUNT T-4	Jul 20, 1976	Substantially Equivalent	Bio-Rad
K760079	REAGENT, THYROXINE T4 (#210)	Jul 20, 1976	Substantially Equivalent	Oxford Laboratories, Inc.