Product Code: KLI FDA class 2 21 CFR 862.1700

Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine

Clinical Chemistry

The Non-Radiolabeled Total Thyroxine Enzyme Immunoassay is an in vitro diagnostic test used in clinical chemistry laboratories to quantitatively measure total thyroxine (T4) concentrations in serum, supporting the assessment of thyroid gland function and the diagnosis or monitoring of thyroid disorders. It is classified as FDA Class 2, indicating moderate risk requiring 510(k) premarket clearance. The product code is KLI and it is regulated under 21 CFR 862.1700 in the Clinical Chemistry specialty.

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Basic Information

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

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 86 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K160495	VITROS® Automation Solutions	Oct 18, 2016	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K131515	ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENT	Aug 14, 2013	Substantially Equivalent	Alfa Wassermann
K103484	GSP NEONATAL THYROXINE (T4)	Apr 22, 2011	Substantially Equivalent	Wallac Oy, A Subsidiary of Perkinelmer, Inc.
K082638	ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL	Feb 26, 2009	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K030860	ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300	Aug 22, 2003	Substantially Equivalent	Monobind
K023369	ACCESS TOTAL T4 ASSAY	Dec 09, 2002	Substantially Equivalent	Beckman Coulter, Inc.
K001603	REPROBEAD T4 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 105)	Oct 05, 2000	Substantially Equivalent	Repromedix Corp.
K000600	SYVA EMIT 2000 THYROXINE ASSAY, CALIBRATORS	Mar 27, 2000	Substantially Equivalent	Syva Co., Dade Behring, Inc.
K991432	BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007	Jun 02, 1999	Substantially Equivalent	Biocheck, Inc.
K982298	OPTICOAT T4 EIA KIT	Feb 03, 1999	Substantially Equivalent	Biotecx Laboratories, Inc.
K983440	ABBOTT ARCHITECT TOTAL T4	Nov 25, 1998	Substantially Equivalent	Abbott Laboratories
K981377	ACE T4 REAGENT T4 CALIBRATORS	Jun 10, 1998	Substantially Equivalent	Schiapparelli Biosystems, Inc.
K972974	ACCUWELL T4-EIA	Oct 06, 1997	Substantially Equivalent	Neometrics, Inc.
K971709	TOTAL THROXINE MICROPLATE EIA(225-300)	Jun 16, 1997	Substantially Equivalent	Monobind
K971269	DSL ACTIVE T4 EIA	May 22, 1997	Substantially Equivalent	Diagnostic Systems Laboratories, Inc.
K971203	SYNCHRON SYSTEMS THYROXINE REAGENT	May 16, 1997	Substantially Equivalent	Beckman Instruments, Inc.
K964721	VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T4 REAGENT PACK (GEM.1005) TOTAL T4 CALIBRATORS (GEM.C005)	Dec 18, 1996	Substantially Equivalent	Johnson & Johnson Clinical Diagnostics, Inc.
K951014	ISOLAB'S T4 TEST KIT	Oct 18, 1996	Substantially Equivalent	Isolab, Inc.
K962211	UBI MAGIWEL THYROXINE (T4) QUANTITATIVE	Jul 08, 1996	Substantially Equivalent	United Biotech, Inc.
K953837	BIOCIRCUITS IOS T4 TEST CARTRIDGE	Nov 20, 1995	Substantially Equivalent	Biocircuits Corp.
K952751	BIOCIRCUITS IOS T4/TU TEST CARTRIDGES	Nov 20, 1995	Substantially Equivalent	Biocircuits Corp.
K951321	RADIAS NEONATAL T4 ENZYME IMMUNOASSAY	Aug 24, 1995	Substantially Equivalent	Bio-Rad
K950588	T4 MICROWELL EIA (ENZYME IMMUNOASSAY0	Jun 29, 1995	Substantially Equivalent	Biomerica, Inc.
K946163	RADIAS TOTAL T4 ENZYME IMMUNOASSAY	Feb 22, 1995	Substantially Equivalent	Bio-Rad
K944703	THYROXINE ENZYME IMMUNOASSAY	Dec 09, 1994	Substantially Equivalent	Diagnostic Reagents, Inc.
K943019	CEDIA T4 MAB ASSAY	Oct 20, 1994	Substantially Equivalent	Microgenics Corp.
K942575	CEDIA T4 MAB ASSAY	Jul 28, 1994	Substantially Equivalent	Microgenics Corp.
K941042	CEDIA T4 MAB ASSAY	Apr 26, 1994	Substantially Equivalent	Microgenics Corp.
K935880	CEDIA T4 MAB ASSAY MODIFICATION	Mar 03, 1994	Substantially Equivalent	Microgenics Corp.
K932605	COBAS (R) CORE T4 EIA	Jan 24, 1994	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K926475	ACCESS(R) THYROXINE ASSAY	Jun 15, 1993	Substantially Equivalent	Bio-Rad Laboratories, Inc.
K926393	VIDAS THYROXINE (T4) ASSAY (T4)	May 13, 1993	Substantially Equivalent	Biomerieux Vitek, Inc.
K922433	VISTA THYROXINE (T-4) ASSAY -- MODIFICATION	Sep 18, 1992	Substantially Equivalent	Syva Co.
K921904	THYROXINE (FPIA) KIT	Jun 24, 1992	Substantially Equivalent	Tudor Laboratories, Inc.
K920712	MEDIX BIOTECH THROXINE ENZYME IMMUNOASSAY TEST KIT	Mar 27, 1992	Substantially Equivalent	Medix Biotech, Inc.
K915194	CEDIA T4	Dec 09, 1991	Substantially Equivalent	Boehringer Mannheim Corp.
K912616	TECHNICON IMMUNO 1 TM SYSTEM ADDITIONAL ANALYTES	Sep 25, 1991	Substantially Equivalent	Technicon Instruments Corp.
K911217	SR1 T4 ENZYME IMMUNOASSAY (MAGNETIC SOLID-PHASE)	Aug 16, 1991	Substantially Equivalent	Serono-Baker Diagnostics, Inc.
K910261	IMMULITE(TM) TOTAL T4	Apr 16, 1991	Substantially Equivalent	Cirrus Diagnostics, Inc.
K903095	IL THYROXINE (T4) ASSAY SYSTEM	Aug 23, 1990	Substantially Equivalent	Instrumentation Laboratory CO
K897072	NDS THYROXINE TEST KIT & NDS THYROXINE CALIBRATOR	Mar 29, 1990	Substantially Equivalent	Kallestad Diag, A Div. of Erbamont, Inc.
K897193	OPUS T4 TEST SYSTEM	Mar 19, 1990	Substantially Equivalent	Pb Diagnostic Systems, Inc.
K897144	THYROXIN(T4) ENZYME IMMUNOASSAY TEST KIT	Mar 15, 1990	Substantially Equivalent	Medix Biotech, Inc.
K896982	AIA-PACK T4	Mar 09, 1990	Substantially Equivalent	Tosoh Corp.
K896865	VITRO T4-EIA-XT	Jan 30, 1990	Substantially Equivalent	In Vitro Diagnostics, Inc.
K896329	D-CHEM TOTAL T4 TEST KIT FOR THYROXINE QUANTITA.	Dec 12, 1989	Substantially Equivalent	Photec Diagnostics, Inc.
K892853	T4 CLASP-BEAD EIA KIT	May 22, 1989	Substantially Equivalent	Biotecx Laboratories, Inc.
K890831	EMIT CONVENIENCE PACK: THYROXINE ASSAY	Apr 14, 1989	Substantially Equivalent	Syva Co.
K884260	THYROXINE MICROASSAY	Feb 23, 1989	Substantially Equivalent	Diamedix Corp.
K885258	ACA THYROXINE (T4 E) METHOD	Feb 17, 1989	Substantially Equivalent	The DU Pont Co.
K885141	EMIT THYROXINE ASSAY	Feb 17, 1989	Substantially Equivalent	Syva Co.
K884700	ANALYST THYROXINE (T4) ROTOR	Jan 27, 1989	Substantially Equivalent	The DU Pont Co.
K884634	MODIFIED CEDIA TOTAL T4 ASSAY	Dec 09, 1988	Substantially Equivalent	Microgenics Corp.
K881357	EMIT CONVENIENCE PACK: THYROXINE ASSAY	May 27, 1988	Substantially Equivalent	Syva Co.
K880620	EMIT THYROXINE ASSAY	Mar 24, 1988	Substantially Equivalent	Syva Co.
K880662	VISION(R) THYROXINE (T4)	Mar 16, 1988	Substantially Equivalent	Abbott Laboratories
K874866	T4 SEROZYME ENZYMEIMMUNOASSAY KIT/MAG. SOLID PHASE	Feb 11, 1988	Substantially Equivalent	Serono Diagnostics, Inc.
K874603	CIBA CORNING T4 LIPIA (LIPOSOME IMMUNOASSAY)	Dec 18, 1987	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K873976	AMERLITE TT4 ASSAY (240/480/144 TEST KITS)	Nov 05, 1987	Substantially Equivalent	Amersham Corp.
K873518	AFFINITY TOTAL THYROXINE IMMUNIT	Oct 29, 1987	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K872192	IMMUBEAD T4 ENZYME IMMUNOASSAY KIT	Aug 13, 1987	Substantially Equivalent	Immunotech Corp.
K862233	CIBA CORNING PRISMA T4 LIPIA (LIPOSOME)	Oct 14, 1986	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K854971	V-TREND EIA T4 ENZYME IMMUNOASSAY TEST KIT	Feb 06, 1986	Substantially Equivalent	V-Tech, Inc.
K852164	CEDIA TOTAL T4 ASSAY	Jul 22, 1985	Substantially Equivalent	Microgenics Corp.
K841601	TERUMO SENSIBEAD THYROXINE EIA KIT	May 22, 1984	Substantially Equivalent	Terumo Medical Corp.
K841576	TECHNICON RA-1000 SYS T4-THYROXINE	May 22, 1984	Substantially Equivalent	Technicon Instruments Corp.
K840473	VENTREZYME T4 IMMUNOASSAY T4	Apr 04, 1984	Substantially Equivalent	Vxr, Inc.
K840241	THYROXINE EMIA	Mar 30, 1984	Substantially Equivalent	Collaborative Research, Inc.
K834102	RA-1000 SYS-T4(THYROXINE)SERUM ANAL	Mar 15, 1984	Substantially Equivalent	Technicon Instruments Corp.
K834210	STRATUS TOTAL THYROXINE FLUOROMETRIC	Mar 05, 1984	Substantially Equivalent	American Dade
K830683	TDX THYROXINE	Apr 06, 1983	Substantially Equivalent	Abbott Laboratories
K830769	FEKAL CON-TRATE SYSTEM	Apr 05, 1983	Substantially Equivalent	Trend Scientific, Inc.
K830136	PARAMOUNT THYROXINE ASSAY	Feb 07, 1983	Substantially Equivalent	Syva Co.
K823751	SOPHEIA THYROXINE EIA KIT	Jan 12, 1983	Substantially Equivalent	Diagnostic Products Corp.
K823034	SYVA ADVANCE THYROXINE ASSAY	Nov 08, 1982	Substantially Equivalent	Syva Co.
K820750	ENZYMUNE-TEST T4	Apr 06, 1982	Substantially Equivalent	Icl Scientific
K810586	EMIT-TFG PRISMA THYROXINE ASSAY	Mar 17, 1981	Substantially Equivalent	Syva Co.
K802693	OREIA-Q-TY, ENZYME IMMUNOASSAY	Dec 10, 1980	Substantially Equivalent	Organon, Inc.
K801475	APPLICATION OF EMIT AED ASSAYS	Jul 08, 1980	Substantially Equivalent	Syva Co.
K801288	EMIT AAII THYROXINE ASSAY	Jun 30, 1980	Substantially Equivalent	Syva Co.
K800384	SMAC SYSTEM, T4 METHOD	Mar 19, 1980	Substantially Equivalent	Technicon Instruments Corp.
K790848	A-GENT QUANTICHROM T4 11A	Aug 10, 1979	Substantially Equivalent	Abbott Laboratories
K790686	EMIT CFA THYROXINE ASSAY	May 25, 1979	Substantially Equivalent	Syva Co.
K782085	EMIT THYROXINE ASSAY	Feb 01, 1979	Substantially Equivalent	Syva Co.
K781828	COMPUTER, 3500, GILFORD SYSTEM	Dec 04, 1978	Substantially Equivalent	Syva Co.
K770070	ENIT ABA THYROXINE ASSAY	Jan 21, 1977	Substantially Equivalent	Syva Co.