Product Code: CDP FDA class 2 21 CFR 862.1710

Radioimmunoassay, Total Triiodothyronine

Clinical Chemistry

The Total Triiodothyronine Radioimmunoassay is a clinical chemistry device that uses radioisotope-labeled antibody techniques to measure the total concentration of triiodothyronine (T3) in serum, used in the diagnosis and monitoring of thyroid disorders including hyperthyroidism and hypothyroidism. It is classified as FDA Class 2 (moderate risk), though it is exempt from 510(k) premarket notification. The product code is CDP, regulated under 21 CFR 862.1710, within the Clinical Chemistry medical specialty. No special flags apply to this device.

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510(k)s

144

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: CDP
Device Class: FDA class 2
Regulation Number: 862.1710
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 144 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K001607	REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104)	Oct 05, 2000	Substantially Equivalent	Repromedix Corp.
K991692	CHIRON DIAGNOSTICS ACS: 180 FT3	Jun 18, 1999	Substantially Equivalent	Chiron Diagnostics Corp.
K991311	TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005	Jun 02, 1999	Substantially Equivalent	Biocheck, Inc.
K991252	AIA-PACK FT3 ASSAY	May 11, 1999	Substantially Equivalent	Tosoh Medics, Inc.
K981824	OPTICOAT T3 EIA KIT	Dec 22, 1998	Substantially Equivalent	Biotecx Laboratories, Inc.
K983439	ABBOTT ARCHITECT FREE T3	Nov 20, 1998	Substantially Equivalent	Abbott Laboratories
K983434	ABBOTT ARCHITECT TOTAL T3	Nov 20, 1998	Substantially Equivalent	Abbott Laboratories
K974027	AURAFLEX FT3 150 TEST PACK, AURAFLEX FT3 CALIBRATOR PACK	Feb 02, 1998	Substantially Equivalent	Alfa Biotech (Uk) , Ltd.
K974634	IMMULITE FREE T3	Jan 02, 1998	Substantially Equivalent	Diagnostic Products Corp.
K973966	ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER	Oct 31, 1997	Substantially Equivalent	Beckman Instruments, Inc.
K971779	TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIA	Jun 16, 1997	Substantially Equivalent	Monobind
K971270	DSL ACTIVE T3 EIA	May 22, 1997	Substantially Equivalent	Diagnostic Systems Laboratories, Inc.
K965058	NICHOLS ADVANTAGE CHEMILUMINESCENCE FREE T3 KIT	Mar 11, 1997	Substantially Equivalent	Nichols Institute Diagnostics
K970016	VITROS IMMUNODIAGNOSITCS PRODUCTS-FREE T3 REAGENT PACK (GEM.1020)/FREE T3 CALIBRATORS (GEM.C020)	Jan 30, 1997	Substantially Equivalent	Johnson & Johnson Clinical Diagnostics, Inc.
K963127	ELECSYS FT3	Dec 16, 1996	Substantially Equivalent	Boehringer Mannheim Corp.
K962760	ENZYMUN-TEST FT3	Nov 29, 1996	Substantially Equivalent	Boehringer Mannheim Corp.
K964310	VITROS IMMUNODIAGNOSTICS PRODUCT - TOTAL T3 REAGENT PACK (GEM .101) AND TOTAL CALIIBRATION (GEM.C010)	Nov 27, 1996	Substantially Equivalent	Johnson & Johnson Clinical Diagnostics, Inc.
K963687	AIA-PACK FT3 ASSAY	Nov 08, 1996	Substantially Equivalent	Tosoh Medics, Inc.
K963833	IMX FREE TRIIODOTHYRONINE (FREE T3)	Oct 30, 1996	Substantially Equivalent	Abbott Laboratories
K963827	AXSYM FREE TRIIODOTHYRONINE (FREE T3)	Oct 30, 1996	Substantially Equivalent	Abbott Laboratories
K962508	ELECSYS T3	Aug 15, 1996	Substantially Equivalent	Boehringer Mannheim Corp.
K962355	FREE TRIIODOTHYRONINE(FT3) ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)	Jul 12, 1996	Substantially Equivalent	Bayer Corp.
K961236	UBI MAGIWEL TRIIODOTHYRONINE(T3) QUANTITATIVE	May 30, 1996	Substantially Equivalent	United Biotech, Inc.
K960913	ACCESS FREE T3 ASSAY	Mar 29, 1996	Substantially Equivalent	Bio-Rad Laboratories, Inc.
K960412	T-3 MICROWELL EIA MODEL 7013	Mar 19, 1996	Substantially Equivalent	Biomerica, Inc.
K960550	ACTIVE T3 RIA	Mar 06, 1996	Substantially Equivalent	Diagnostic Systems Laboratories, Inc.
K955435	ACCESS TOTAL T3 ASSAY (MODIFICATION)	Jan 24, 1996	Substantially Equivalent	Bio-Rad Laboratories, Inc.
K952557	TOTAL T-3 FPIA REAGENT SET, TOTAL T-3 FPIA CALIBRATORS	Jan 24, 1996	Substantially Equivalent	Sigma Diagnostics, Inc.
K953160	OPUS T3	Aug 24, 1995	Substantially Equivalent	Behring Diagnostics, Inc.
K944808	IMX T3 ASSAY	Dec 09, 1994	Substantially Equivalent	Organon Teknika Corp.
K940833	ACCESS(R) TOTAL T3	Sep 07, 1994	Substantially Equivalent	Bio-Rad Laboratories, Inc.
K936229	AIA-PACK TT3 ASSAY	Jul 14, 1994	Substantially Equivalent	Tosoh Medics, Inc.
K934517	AXSYM TOTAL T3	Jun 21, 1994	Substantially Equivalent	Abbott Laboratories
K934764	VIDAS T3 ASSAY	Mar 22, 1994	Substantially Equivalent	Biomerieux Vitek, Inc.
K932747	CIBA CORNING ACS FREE T3 IMMUNOASSAY	Dec 03, 1993	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K932608	COBAS(R) CORE T3 EIA	Dec 03, 1993	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K931600	CHEMILUMINESCENCE FREE T3 IMMUNOASSAY	Sep 08, 1993	Substantially Equivalent	Nichols Institute
K926345	TRIODOTHYRONINE (TC) COATED TUBE RIA	Feb 25, 1993	Substantially Equivalent	Monobind
K925436	MEDIX BIOTECH TOTAL T3 ENZYME IMMUNOASSAY TEST KIT	Dec 28, 1992	Substantially Equivalent	Medix Biotech, Inc.
K923571	VISTA TRIIODOTHYRONINE ASSAY	Oct 15, 1992	Substantially Equivalent	Syva Co.
K922771	KODAK AMERLEX MAB FT3 ASSAY	Oct 14, 1992	Substantially Equivalent	Eastman Kodak Company
K923258	TECHNICON IMMUNO 1 SYSTEM TOTAL TRIIODOTHYRONINE	Sep 23, 1992	Substantially Equivalent	Heraeus Kulzer, Inc.
K923015	TOTAL T3 CHEMILUMINESCENCE ASSAY	Sep 02, 1992	Substantially Equivalent	Nichols Institute Diagnostics
K915792	DOCUMENT CK ISOENZYMES CONTROL	Feb 06, 1992	Substantially Equivalent	Casco Standards
K914467	MILENIA TOTAL T3	Feb 06, 1992	Substantially Equivalent	Diagnostic Products Corp.
K910737	SRI T3 IMMOENZYMETRIC ASSAY	May 01, 1991	Substantially Equivalent	Serono-Baker Diagnostics, Inc.
K905410	OPUS T3 TEST SYSTEM	Feb 04, 1991	Substantially Equivalent	Pb Diagnostic Systems, Inc.
K905214	IMMULITE (TM) TOTAL T3	Feb 01, 1991	Substantially Equivalent	Cirrus Diagnostics, Inc.
K905656	FLAGEN TRIIODOTHYRONINE (T3) ASSAY	Jan 23, 1991	Substantially Equivalent	Cyberfluor, Inc.
K905261	IMX FREE TRIIODOTHYRONINE	Jan 23, 1991	Substantially Equivalent	Abbott Laboratories
K904820	MICROZYME T3 ENZYME IMMUNOASSAY KIT	Dec 18, 1990	Substantially Equivalent	Immunotech Corp.
K903433	TDX FREE T3 CALCULATION	Oct 12, 1990	Substantially Equivalent	Abbott Laboratories
K904098	CEDIA TOTAL T3 ASSAY	Sep 27, 1990	Substantially Equivalent	Microgenics Corp.
K903432	IMX FREE T3 CALCULATION	Sep 07, 1990	Substantially Equivalent	Abbott Laboratories
K897001	TOSOH AIA-PACK T3	Mar 09, 1990	Substantially Equivalent	Tosoh Corp.
K896900	ENZYMUN TEST R T3	Feb 08, 1990	Substantially Equivalent	Boehringer Mannheim Corp.
K894238	ABBOTT TDX TOTAL T3 PLUS	Oct 31, 1989	Substantially Equivalent	Abbott Laboratories
K895840	MILENIA(TM) TOTAL T4 (MKT41,5)	Oct 19, 1989	Substantially Equivalent	Diagnostic Products Corp.
K894993	STRATUS(R) TOTAL TRIIODOTHYRONINE (T3) F.E.I.	Oct 13, 1989	Substantially Equivalent	Baxter Healthcare Corp
K894200	FREE T3 RADIOIMMUNOASSAY KIT	Sep 25, 1989	Substantially Equivalent	Advanced Magnetics, Inc.
K893620	T3 CLASP-BEAD EIA KIT	Aug 11, 1989	Substantially Equivalent	Biotecx Laboratories, Inc.
K885195	AMERLITE FT3 ASSAY, LAN.0007/2007 240/144 TEST KIT	Feb 08, 1989	Substantially Equivalent	Amersham Corp.
K883810	DELFIA TRIIODOTHYRONINE (T3) KIT	Dec 02, 1988	Substantially Equivalent	Pharmacia, Inc.
K883479	STRATUS TOTAL TRIIODOTHYRONINE T3 FLUORO. ENZYME	Oct 25, 1988	Substantially Equivalent	Baxter Healthcare Corp
K881373	AMERLITE TT3 ASSAY, LAN.0003/2003 240/144 KIT	May 27, 1988	Substantially Equivalent	Amersham Corp.
K881214	IMMPULSE T, ASSAY REAGENTS	May 27, 1988	Substantially Equivalent	Sclavo, Inc.
K880087	ABBOTT IMX T3	Apr 18, 1988	Substantially Equivalent	Abbott Laboratories
K880388	T3 SEROZYME ENZYMEIMMUNOASSAY KIT, MAG SOLID PHASE	Mar 03, 1988	Substantially Equivalent	Serono Diagnostics, Inc.
K873737	NO SPIN(TM) T3 COATED TUBE RADIOIMMUNOASSAY	Nov 24, 1987	Substantially Equivalent	Cambridge Medical Technology
K873945	CIBA CORNING MAGIC LITE T3 IMMUNOASSAY	Nov 23, 1987	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K873858	AMERLITE TT3 ASSAY, LAN.0003/1003/2003	Nov 03, 1987	Substantially Equivalent	Amersham Corp.
K872191	IMMUBEAD T3 ENZYME IMMUNOASSAY KIT	Aug 13, 1987	Substantially Equivalent	Immunotech Corp.
K870968	TOTAL T3-RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT	Jun 22, 1987	Substantially Equivalent	Canadian Bioclinical, Ltd.
K864452	DELFIA(TM) TRIIODOTHYRONINE (T3) KIT	Feb 02, 1987	Substantially Equivalent	Lkb Instruments, Inc.
K860252	AMERLEX-M T3 RIA KIT FOR SERUM AND PLASMA	Feb 11, 1986	Substantially Equivalent	Amersham Corp.
K853703	VENTREZYME T3 IMMUNOASSAY T3	Oct 04, 1985	Substantially Equivalent	Vxr, Inc.
K852537	T-3 RIASSAY	Aug 12, 1985	Substantially Equivalent	Ria Diagnostics
K851676	TDX TOTAL T3	May 20, 1985	Substantially Equivalent	Abbott Laboratories
K842949	AMERLEX-M FREE T-3 RIA	Sep 05, 1984	Substantially Equivalent	Amersham Corp.
K842590	AMER. BIO-SCIENCE LAB T3 REAGENTS	Aug 10, 1984	Substantially Equivalent	American Bio-Science Laboratories
K840222	CORNING IMMO PHASE FREE T3	May 07, 1984	Substantially Equivalent	Corning Medical & Scientific
K840959	FREE T3 SOLID PHASE RADIOIMMUNOASSAY	Apr 18, 1984	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K840050	SOPHEIA T3 EIA KIT	Mar 19, 1984	Substantially Equivalent	Diagnostic Products Corp.
K834348	LEECO T3-QUANT DIAG. KIT	Feb 21, 1984	Substantially Equivalent	Leeco Diagnostics, Inc.
K833853	T3 RIA	Feb 04, 1984	Substantially Equivalent	Syncor Intl. Corp.
K834049	ENDAB T3	Jan 30, 1984	Substantially Equivalent	Immunotech Corp.
K832164	COAT-A-COUNT FREE T3 RIA KIT	Oct 27, 1983	Substantially Equivalent	Diagnostic Products Corp.
K832469	T3-RIA SINGLE REAGENT	Sep 12, 1983	Substantially Equivalent	Fairlake Laboratories
K832353	CORNING'S MAGIC T3(125I) RADIOIMMUNO-	Aug 31, 1983	Substantially Equivalent	Corning Medical & Scientific
K831434	ISO-SEP SYSTEM	Jun 30, 1983	Substantially Equivalent	Berwick Medical Products, Inc.
K830980	AMERLEX FREE T-3 RIA KIT	May 25, 1983	Substantially Equivalent	Amersham Corp.
K831064	PHASE II T3 RADIOIMMUNOASSAY KIT	May 09, 1983	Substantially Equivalent	Medical & Scientific Designs, Inc.
K830808	LEECO T3-RIA DIAGNOSTIC KIT	Apr 08, 1983	Substantially Equivalent	Leeco Diagnostics, Inc.
K821725	T3 DIAGNOSTIC KIT RIA	Jun 24, 1982	Substantially Equivalent	Diagnostic Reagents, Inc.
K820251	T4 DIAGNOSTIC KIT	May 05, 1982	Substantially Equivalent	Diagnostic Reagents, Inc.
K820763	ENZYM-LINKED T3	Apr 15, 1982	Substantially Equivalent	Icl Scientific
K812666	THYROXINE (T4) 125I	Oct 02, 1981	Substantially Equivalent	Pcl-Ria, Inc.
K812611	QUANTICOAT NEONATAL 125 T4 RADIOIMMUNO	Oct 02, 1981	Substantially Equivalent	Kallestad Laboratories, Inc.
K812246	COAT-A-COUNT T3 RIA KIT	Aug 20, 1981	Substantially Equivalent	Diagnostic Products Corp.
K811213	T3 (RIA) KIT	May 29, 1981	Substantially Equivalent	Immuno Assay Corp.
K810798	TECHNICON STAR SYSTEM T3 RIA METHOD	Apr 07, 1981	Substantially Equivalent	Technicon Instruments Corp.
K810351	RADIOIMMUNOASSAY, TOTAL TRIIODOTHRONIE	Feb 23, 1981	Substantially Equivalent	Endocrine-Metabolic Center
K810211	T3 RIA KIT	Feb 10, 1981	Substantially Equivalent	E. R. Squibb & Sons, Inc.
K803261	T3 RIABEAD DIAGNOSTIC KIT	Jan 15, 1981	Substantially Equivalent	Abbott Laboratories
K803180	1-125 LABELED TRIIODOTHYRONINE(T3)	Jan 09, 1981	Substantially Equivalent	Pcl-Ria, Inc.
K802883	T3-SQUIBB RIA KIT	Dec 19, 1980	Substantially Equivalent	E. R. Squibb & Sons, Inc.
K802470	T3 RADIOIMMUNOASSAY KIT	Nov 12, 1980	Substantially Equivalent	American Diagnostic Corp.
K801843	T3(125) RADIOIMMUNOASSAY KIT	Sep 16, 1980	Substantially Equivalent	Technia Diagnostics , Ltd.
K801125	SPAC T3 RIA TEST KIT	Jun 09, 1980	Substantially Equivalent	Mallinckrodt Critical Care
K801123	TRIIODOTHYRONINE RADIOIMMUN. SYSTEM	Jun 09, 1980	Substantially Equivalent	Calbiochem-Behring Corp.
K800436	T3 SOLID PHASE RADIOIMMUNOASSAY KIT	Mar 19, 1980	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K800374	AMERLEX T-3 RIA KIT	Mar 12, 1980	Substantially Equivalent	Amersham Corp.
K792539	TRIIODOTHYRONINE RIA SYSTEM	Jan 16, 1980	Substantially Equivalent	Radioimmunoassay, Inc.
K791375	AUTOPAK 12 T3 RIA TEST DELIVERY SYSTEM	Oct 11, 1979	Substantially Equivalent	Micromedic Systems
K791663	IMMUCHEM COVALENT COAT SOLID PHASE ASSAY	Oct 01, 1979	Substantially Equivalent	Immuchem Corp.
K791588	VENTRE/SEP T3 TEST SET	Sep 27, 1979	Substantially Equivalent	Ventrex Laboratories, Inc.
K791317	IREX REAL TIME PHASED ARRAY SYSTEM	Sep 17, 1979	Substantially Equivalent	Irex Corp.
K791232	DAC-CEL T3	Sep 04, 1979	Substantially Equivalent	Burroughs Wellcome Co.
K790960	QUANTIMUNE T-3 FIA	Aug 10, 1979	Substantially Equivalent	Bio-Rad
K790908	RIA, TEST SET CENTRIA T3	Jun 27, 1979	Substantially Equivalent	Ventrex Laboratories, Inc.
K790581	CHROMATOGRAPHY TUBES	May 15, 1979	Substantially Equivalent	Miles Laboratories, Inc.
K781481	ORTHO*T-3 RIA (PEG) KIT	Sep 27, 1978	Substantially Equivalent	Ortho Diagnostics, Inc.
K781284	RABBIT ANTIBODY TO HUMAN T3	Aug 31, 1978	Substantially Equivalent	Pcl-Ria, Inc.
K780787	TRIIODOTHYRONINE RADIOIMMUNOASSAY KIT	Jun 06, 1978	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K780499	CBR-T3RIA KIT	May 04, 1978	Substantially Equivalent	Clinical Bioresearch
K780492	GAMMA STIK 125I T3 UPTAKE KIT	Apr 28, 1978	Substantially Equivalent	Alpha Gamma Laboratory
K780292	TRIA-PEG RIA DIAG. KIT	Mar 02, 1978	Substantially Equivalent	Nuclear Diagnostics, Inc.
K780018	THYRO-INDICATOR T-3 125I	Feb 07, 1978	Substantially Equivalent	Clinical Immuno-Diagnostics
K772177	TRI-TAB-RIA	Dec 22, 1977	Substantially Equivalent	Nuclear Medical Laboratories, Inc.
K772122	T3 RIA KIT	Nov 17, 1977	Substantially Equivalent	Antibodies, Inc.
K772108	IN VITRO T3 RIA TEST	Nov 17, 1977	Substantially Equivalent	Clinical Assays, Inc.
K771623	T3 RIA	Sep 20, 1977	Substantially Equivalent	Hoffmann-La Roche, Inc.
K771220	T3 RIA TEST SYSTEM	Aug 04, 1977	Substantially Equivalent	Monobind
K771142	T3 CLASP RIA KIT	Jul 14, 1977	Substantially Equivalent	E. R. Squibb & Sons, Inc.
K770739	SERUM SET, THYROID CONTROL	Jun 22, 1977	Substantially Equivalent	G.D. Searle and Co.
K770738	REAGENT, T-3 UPTAKE	Jun 22, 1977	Substantially Equivalent	G.D. Searle and Co.
K770918	LIQUI SOL T4 RIA TEST KIT	Jun 17, 1977	Substantially Equivalent	Damon Corp.
K770648	QUANTIMUNE T-3 RIA	Jun 14, 1977	Substantially Equivalent	Bio-Rad
K770520	RADIOIMMUNOASSAY, QUANTITIPE 125-I-T3	Jun 03, 1977	Substantially Equivalent	Kallestad Laboratories, Inc.
K770677	T-3 RIA REAGENT SET	May 20, 1977	Substantially Equivalent	G.D. Searle and Co.
K770201	T3 RIA (PEG) DIAGNOSTIC KIT	Apr 05, 1977	Substantially Equivalent	Abbott Laboratories
K761305	CENTRIA T3 RIA	Dec 30, 1976	Substantially Equivalent	Union Carbide Corp.
K760057	TEST, RIA, TRIODOTHYRONINE	Sep 13, 1976	Substantially Equivalent	Smithkline Diagnostics, Inc.
K760078	REAGENT, RIA TRIIODOTHYRONINE T3 (#200)	Jul 20, 1976	Substantially Equivalent	Oxford Laboratories, Inc.