Product Code: KHQ FDA class 2 21 CFR 862.1715

Radioassay, Triiodothyronine Uptake

Clinical Chemistry

Triiodothyronine Uptake Radioassay is an in vitro diagnostic test that uses radioisotope methodology to measure the binding of triiodothyronine (T3) to serum proteins, providing an indirect assessment of thyroid hormone binding capacity and free thyroid hormone levels to support evaluation of thyroid function. It is classified as FDA Class 2, indicating moderate risk; devices in this category are subject to general controls and special controls, and typically require 510(k) premarket notification demonstrating substantial equivalence to a predicate device. The product code is KHQ, regulated under 21 CFR 862.1715, within the Clinical Chemistry medical specialty.

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Basic Information

Product Code: KHQ
Device Class: FDA class 2
Regulation Number: 862.1715
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 4

Device Characteristics

✗

GMP Exempt

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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 93 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K981375	ACE T UPTAKE REAGENT TU CALIBRATORS	Jun 10, 1998	Substantially Equivalent	Schiapparelli Biosystems, Inc.
K980088	T-UPTAKE MICROPLATE EIA	Feb 04, 1998	Substantially Equivalent	Monobind
K970539	CHIRON DIAGNOSTICS ACS:180TU P	Mar 24, 1997	Substantially Equivalent	Chiron Diagnostics Corp.
K964308	VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAKE CALIBRATORS (GEM.C025)	Nov 27, 1996	Substantially Equivalent	Johnson & Johnson Clinical Diagnostics, Inc.
K961488	ELECSYS T-UPTAKE ASSAY	Jun 12, 1996	Substantially Equivalent	Boehringer Mannheim Corp.
K954807	CEDIA T UPTAKE ASSAY	Dec 21, 1995	Substantially Equivalent	Boehringer Mannheim Corp.
K951586	T-UPTAKE EIA TEST	May 15, 1995	Substantially Equivalent	Diagnostic Reagents, Inc.
K933414	STRATUS(R) THYROID UPTAKE FLUOR ENZYME IMMUNOASSAY	Nov 22, 1994	Substantially Equivalent	Baxter Diagnostics, Inc.
K934312	AXSYM(TM) T-UPTAKE	Jun 21, 1994	Substantially Equivalent	Abbott Laboratories
K935816	VIDAS T UPTAKE	Mar 22, 1994	Substantially Equivalent	Biomerieux Vitek, Inc.
K926220	T3 UPTAKE CHEMILUMINESCENCE ASSAY	Nov 17, 1993	Substantially Equivalent	Nichols Institute Diagnostics
K931294	IQ TUPTAKE ASSAY	Jul 22, 1993	Substantially Equivalent	Becton Dickinson Advanced Diagnostics
K926443	COBAS(R)-FP REAGENTS FOR T-UPTAKE/CALIBRATORS	May 20, 1993	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K925257	CIBA CORNING ACS T UPTAKE IMMUNOASSAY	Dec 28, 1992	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K923676	VISTA THYROXINE UPTAKE ASSAY	Oct 09, 1992	Substantially Equivalent	Syva Co.
K913663	AIA-PACK T-U	Sep 30, 1991	Substantially Equivalent	Tosoh Corp.
K911912	SR1 T3 UPTAKE ENZYME IMMUNOASSAY(MAG SOLID-PHASE)	Sep 18, 1991	Substantially Equivalent	Serono-Baker Diagnostics, Inc.
K911093	CIBA CORNING ACS T UPTAKE IMMUNOASSAY	Apr 29, 1991	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K903396	IL T UPTAKE ASSAY SYSTEM	Oct 12, 1990	Substantially Equivalent	Instrumentation Laboratory CO
K902748	SEROZYME FREE T3 IMMUNOASSAY	Aug 09, 1990	Substantially Equivalent	Advanced Magnetics, Inc.
K902797	OPUS TM T-UPTAKE TEST SYSTEM	Jul 30, 1990	Substantially Equivalent	Pb Diagnostic Systems, Inc.
K896925	T UPTAKE ENZYME IMMUNOASSAY CRIMPED TUBE KIT	Jan 18, 1990	Substantially Equivalent	In Vitro Diagnostics, Inc.
K895186	FIAGEN T3 UPTAKE CATALOGUE #101-402	Nov 08, 1989	Substantially Equivalent	Cyberfluor, Inc.
K894145	EMIT T-UPTAKE ASSAY	Sep 05, 1989	Substantially Equivalent	Syva Co.
K892224	D-CHEM(TM) T-UPTAKE TEST KIT FOR T-UPTAKE DETERMIN	Jun 16, 1989	Substantially Equivalent	Photec Diagnostics, Inc.
K891068	VENTREX COATED TUBE T3 UPTAKE	Apr 10, 1989	Substantially Equivalent	Ventrex Laboratories, Inc.
K885259	ACA THYRONINE UPTAKE (TU E) METHOD	Feb 17, 1989	Substantially Equivalent	The DU Pont Co.
K883765	TBG 125I RIA KIT, RADIOIMMUNO. OF SERUM THYROXINE	Oct 31, 1988	Substantially Equivalent	Biotecx Laboratories, Inc.
K883085	T3 UPTAKE SEROZYME ENZYME IMMUNO KT/MAG SOLID PHAS	Sep 09, 1988	Substantially Equivalent	Serono Diagnostics, Inc.
K881855	EMIT CONVENIENCE PACK: T-UPTAKE ASSAY	Jun 10, 1988	Substantially Equivalent	Syva Co.
K880619	EMIT T-UPTAKE ASSAY THYROID HORMONE BINDING RATIO	Apr 18, 1988	Substantially Equivalent	Syva Co.
K874362	AMERLITE T3U ASSAY LAN.0004/1004/2004, 240/480/144	Feb 18, 1988	Substantially Equivalent	Amersham Corp.
K872447	CEDIA(TM) T UPTAKE	Aug 21, 1987	Substantially Equivalent	Microgenics Corp.
K872172	IMMUBEAD THYROID UPTAKE	Aug 17, 1987	Substantially Equivalent	Immunotech Corp.
K865083	AFFINITY(TM) I UPTAKE IMMUNIT(TM)	Jul 09, 1987	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K864132	CIBA CORNING MAGIC(R) LITE TU IMMUNOASSAY	Dec 16, 1986	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K862447	PANCOAT T3 UPTAKE COATED TUBE RADIOIMMUNOASSAY KIT	Oct 07, 1986	Substantially Equivalent	Pantex, Div. Bio-Analysis, Inc.
K862968	FREE T3 RADIOIMMUNOASSAY KIT	Sep 25, 1986	Substantially Equivalent	Bioclinical Group
K861262	MMS T3 UPTAKE	May 23, 1986	Substantially Equivalent	Micromedic Systems
K860422	STRAT THYROID UPTAKE FLUROMET ENZYME IMMUNOASSAY	Apr 11, 1986	Substantially Equivalent	American Dade
K855169	T3 UPTAKE RADIOIMMUNOASSAY KIT	Feb 06, 1986	Substantially Equivalent	Cambridge Medical Technology
K855033	T-3 UPTAKE/RIASSAY	Jan 24, 1986	Substantially Equivalent	Ria Diagnostics
K842694	TERUMO SENSIBEAD EIA THYROID UPTAKE KIT	Sep 07, 1984	Substantially Equivalent	Terumo Medical Corp.
K841927	T3 UPTAKE	Jun 25, 1984	Substantially Equivalent	Syncor Intl. Corp.
K840853	IMMPULSE TBC ASSAY REAGENTS	Apr 01, 1984	Substantially Equivalent	Paragon Diagnostics, Inc.
K840589	TRI-TUBE RIA	Mar 09, 1984	Substantially Equivalent	Nuclear Medical Laboratories, Inc.
K834209	STRATUS THYROID UPTAKE FLUOROMETRIC	Mar 09, 1984	Substantially Equivalent	American Dade
K833703	ACA THYROXINE UPTAKE ANALYTICAL TEST	Jan 30, 1984	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K831613	MAGIC TM 125I T3 UPTAKE RADIOASSAY	Aug 11, 1983	Substantially Equivalent	Corning Medical & Scientific
K830900	UPTAKE T3 RADIOIMMUNOASSAY KIT	Apr 18, 1983	Substantially Equivalent	Medical & Scientific Designs, Inc.
K830912	TDX T-UPTAKE	Apr 12, 1983	Substantially Equivalent	Abbott Laboratories
K822592	ADVANCE TM T-3 UPTAKE ASSAY	Oct 08, 1982	Substantially Equivalent	Syva Co.
K822612	T3 UPTAKE KITS	Sep 30, 1982	Substantially Equivalent	Pcl-Ria, Inc.
K822575	LEECO T3% DIAGNOSTIC KIT	Sep 30, 1982	Substantially Equivalent	Leeco Diagnostics, Inc.
K821553	ZETAPHASE T3 UPTAKE DIAGNOSTIC KIT	Jun 25, 1982	Substantially Equivalent	Amf Biological and Diagnostics Co.
K821722	T3 UPTAKE DIAGNOSTIC KIT	Jun 24, 1982	Substantially Equivalent	Diagnostic Reagents, Inc.
K820879	ENZYME-TEST TBC T4 UPTAKE	Apr 16, 1982	Substantially Equivalent	Icl Scientific
K820340	T3 UPTAKE-SQUIBB DIAGNOSTIC KIT	Mar 04, 1982	Substantially Equivalent	E. R. Squibb & Sons, Inc.
K810857	T3 UPTAKE KIT	Apr 08, 1981	Substantially Equivalent	Immuno Assay Corp.
K810717	COAT-A-COUNT T3 UPTAKE KIT	Mar 31, 1981	Substantially Equivalent	Diagnostic Products Corp.
K810212	DAC-CEL T3 UPTAKE	Feb 10, 1981	Substantially Equivalent	Burroughs Wellcome Co.
K803044	IMMU-TRACE T3 UPTAKE (T3U) REAGENTS	Jan 02, 1981	Substantially Equivalent	American Dade
K802468	T3 UPTAKE TEST SYSTEM	Oct 31, 1980	Substantially Equivalent	American Diagnostic Corp.
K802464	OREAI-Q-TU TEST	Oct 31, 1980	Substantially Equivalent	Organon, Inc.
K802246	ANALYTE T3 UPTAKE	Oct 23, 1980	Substantially Equivalent	Technicon Instruments Corp.
K800911	A-GENT THYROZYME UPTAKE INHIBITOR ASSAY	Jun 20, 1980	Substantially Equivalent	Abbott Laboratories
K800188	EMC-M-180, T3 UPTAKE - 100 TUBES	Feb 13, 1980	Substantially Equivalent	Endocrine-Metabolic Center
K800170	AMES RIALYZE - UPTAKE CHROM. TUBES	Feb 13, 1980	Substantially Equivalent	Miles Laboratories, Inc.
K800165	VENTRE/SEP T3 UPTAKE RADIOASSAY	Feb 13, 1980	Substantially Equivalent	Ventrex Laboratories, Inc.
K792662	AUTOPAK-12 UPTAKE TEST DELIVERY SYSTEM	Jan 17, 1980	Substantially Equivalent	Micromedic Systems
K792607	T3 UPTAKE (T3U) REAGENTS	Jan 16, 1980	Substantially Equivalent	Dade, Baxter Travenol Diagnostics, Inc.
K792484	TIPSEP-T3U TRIIODOTHYRONINE UPTAKE	Dec 27, 1979	Substantially Equivalent	Nuclear Diagnostics, Inc.
K791662	IMMUCHEM COVALENT COAT BINDING	Sep 27, 1979	Substantially Equivalent	Immuchem Corp.
K791361	T3 UPTAKE RADIOIMMUNOASSAY KIT	Aug 16, 1979	Substantially Equivalent	Technia Diagnostics , Ltd.
K790461	T-3 UPTAKE (MAA) KIT	May 03, 1979	Substantially Equivalent	Amersham Corp.
K790417	T3 UPTAKE KIT	Apr 20, 1979	Substantially Equivalent	E. R. Squibb & Sons, Inc.
K781905	RIA KIT, QUANTITOPE T3 UPTAKE	Jan 03, 1979	Substantially Equivalent	Kallestad Laboratories, Inc.
K781662	RIA, T3 UPTAKE SOLID PHASE	Nov 08, 1978	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K781482	ORTHO*T-3 UPTAKE KIT	Sep 27, 1978	Substantially Equivalent	Ortho Diagnostics, Inc.
K781180	CLINIRIA T-3 UPTAKE TEST	Aug 14, 1978	Substantially Equivalent	Miles Laboratories, Inc.
K780525	T-3 UPTAKE (SORBENT) KIT	May 19, 1978	Substantially Equivalent	Amersham Corp.
K780500	CBR-T3 UPTAKE KIT	May 03, 1978	Substantially Equivalent	Clinical Bioresearch
K780253	REAGENT SYSTEM, ARIA II T3 UPTAKE	Mar 28, 1978	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K780361	T3 UPTAKE TEST	Mar 22, 1978	Substantially Equivalent	Monobind
K780146	T3 STI KIT	Feb 23, 1978	Substantially Equivalent	Polysciences, Inc.
K771854	SPINSEP-T3	Dec 22, 1977	Substantially Equivalent	Nuclear Diagnostics, Inc.
K772088	AMES T-3 UPTAKE STRIP TEST	Dec 06, 1977	Substantially Equivalent	Miles Laboratories, Inc.
K771078	PHADEBAS T3 U TEST	Jun 27, 1977	Substantially Equivalent	Pharmacia, Inc.
K770845	T3 UPTAKE REAGENT SET	May 26, 1977	Substantially Equivalent	The Dow Chemical Co.
K770480	IN VITRO T-3 UPTAKE TEST	Apr 06, 1977	Substantially Equivalent	Clinical Assays, Inc.
K761281	DATA-TOPE T3 UPTAKE PROCEDURE	Feb 09, 1977	Substantially Equivalent	Dade, Baxter Travenol Diagnostics, Inc.
K770033	SPAC TM T3 UPTAKE KIT	Feb 07, 1977	Substantially Equivalent	Mallinckrodt Critical Care
K760802	T-3 UPTAKE KIT	Oct 29, 1976	Substantially Equivalent	Diagnostic Products Corp.