KLI · Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
Clinical Chemistry · 21 CFR 862.1700 · Class 2
Overview
| Product Code | KLI |
|---|---|
| Device Name | Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine |
| Regulation | 21 CFR 862.1700 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
Identification
A total thyroxine test system is a device intended to measure total (free and protein bound) thyroxine (thyroid hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Cleared Devices (86)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K160495 | VITROS® Automation Solutions | Ortho-Clinical Diagnostics, Inc. | Oct 18, 2016 | SESE |
| K131515 | ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENT | Alfa Wassermann | Aug 14, 2013 | SESE |
| K103484 | GSP NEONATAL THYROXINE (T4) | Wallac Oy, A Subsidiary of Perkinelmer, Inc. | Apr 22, 2011 | SESE |
| K082638 | ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL | Siemens Healthcare Diagnostics, Inc. | Feb 26, 2009 | SESE |
| K030860 | ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300 | Monobind | Aug 22, 2003 | SESE |
| K023369 | ACCESS TOTAL T4 ASSAY | Beckman Coulter, Inc. | Dec 9, 2002 | SESE |
| K001603 | REPROBEAD T4 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 105) | Repromedix Corp. | Oct 5, 2000 | SESE |
| K000600 | SYVA EMIT 2000 THYROXINE ASSAY, CALIBRATORS | Syva Co., Dade Behring, Inc. | Mar 27, 2000 | SESE |
| K991432 | BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007 | Biocheck, Inc. | Jun 2, 1999 | SESE |
| K982298 | OPTICOAT T4 EIA KIT | Biotecx Laboratories, Inc. | Feb 3, 1999 | SESE |
| K983440 | ABBOTT ARCHITECT TOTAL T4 | Abbott Laboratories | Nov 25, 1998 | SESE |
| K981377 | ACE T4 REAGENT T4 CALIBRATORS | Schiapparelli Biosystems, Inc. | Jun 10, 1998 | SESE |
| K972974 | ACCUWELL T4-EIA | Neometrics, Inc. | Oct 6, 1997 | SESE |
| K971709 | TOTAL THROXINE MICROPLATE EIA(225-300) | Monobind | Jun 16, 1997 | SESE |
| K971269 | DSL ACTIVE T4 EIA | Diagnostic Systems Laboratories, Inc. | May 22, 1997 | SESE |
| K971203 | SYNCHRON SYSTEMS THYROXINE REAGENT | Beckman Instruments, Inc. | May 16, 1997 | SESE |
| K964721 | VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T4 REAGENT PACK (GEM.1005) TOTAL T4 CALIBRATORS (GEM.C005) | Johnson & Johnson Clinical Diagnostics, Inc. | Dec 18, 1996 | SESE |
| K951014 | ISOLAB'S T4 TEST KIT | Isolab, Inc. | Oct 18, 1996 | SESE |
| K962211 | UBI MAGIWEL THYROXINE (T4) QUANTITATIVE | United Biotech, Inc. | Jul 8, 1996 | SESE |
| K953837 | BIOCIRCUITS IOS T4 TEST CARTRIDGE | Biocircuits Corp. | Nov 20, 1995 | SESE |
| K952751 | BIOCIRCUITS IOS T4/TU TEST CARTRIDGES | Biocircuits Corp. | Nov 20, 1995 | SESE |
| K951321 | RADIAS NEONATAL T4 ENZYME IMMUNOASSAY | Bio-Rad | Aug 24, 1995 | SESE |
| K950588 | T4 MICROWELL EIA (ENZYME IMMUNOASSAY0 | Biomerica, Inc. | Jun 29, 1995 | SESE |
| K946163 | RADIAS TOTAL T4 ENZYME IMMUNOASSAY | Bio-Rad | Feb 22, 1995 | SESE |
| K944703 | THYROXINE ENZYME IMMUNOASSAY | Diagnostic Reagents, Inc. | Dec 9, 1994 | SESE |
| K943019 | CEDIA T4 MAB ASSAY | Microgenics Corp. | Oct 20, 1994 | SESE |
| K942575 | CEDIA T4 MAB ASSAY | Microgenics Corp. | Jul 28, 1994 | SESE |
| K941042 | CEDIA T4 MAB ASSAY | Microgenics Corp. | Apr 26, 1994 | SESE |
| K935880 | CEDIA T4 MAB ASSAY MODIFICATION | Microgenics Corp. | Mar 3, 1994 | SESE |
| K932605 | COBAS (R) CORE T4 EIA | Roche Diagnostic Systems, Inc. | Jan 24, 1994 | SESE |
| K926475 | ACCESS(R) THYROXINE ASSAY | Bio-Rad Laboratories, Inc. | Jun 15, 1993 | SESE |
| K926393 | VIDAS THYROXINE (T4) ASSAY (T4) | Biomerieux Vitek, Inc. | May 13, 1993 | SESE |
| K922433 | VISTA THYROXINE (T-4) ASSAY -- MODIFICATION | Syva Co. | Sep 18, 1992 | SESE |
| K921904 | THYROXINE (FPIA) KIT | Tudor Laboratories, Inc. | Jun 24, 1992 | SESE |
| K920712 | MEDIX BIOTECH THROXINE ENZYME IMMUNOASSAY TEST KIT | Medix Biotech, Inc. | Mar 27, 1992 | SESE |
| K915194 | CEDIA T4 | Boehringer Mannheim Corp. | Dec 9, 1991 | SESE |
| K912616 | TECHNICON IMMUNO 1 TM SYSTEM ADDITIONAL ANALYTES | Technicon Instruments Corp. | Sep 25, 1991 | SESE |
| K911217 | SR1 T4 ENZYME IMMUNOASSAY (MAGNETIC SOLID-PHASE) | Serono-Baker Diagnostics, Inc. | Aug 16, 1991 | SESE |
| K910261 | IMMULITE(TM) TOTAL T4 | Cirrus Diagnostics, Inc. | Apr 16, 1991 | SESE |
| K903095 | IL THYROXINE (T4) ASSAY SYSTEM | Instrumentation Laboratory CO | Aug 23, 1990 | SESE |
| K897072 | NDS THYROXINE TEST KIT & NDS THYROXINE CALIBRATOR | Kallestad Diag, A Div. of Erbamont, Inc. | Mar 29, 1990 | SESE |
| K897193 | OPUS T4 TEST SYSTEM | Pb Diagnostic Systems, Inc. | Mar 19, 1990 | SESE |
| K897144 | THYROXIN(T4) ENZYME IMMUNOASSAY TEST KIT | Medix Biotech, Inc. | Mar 15, 1990 | SESE |
| K896982 | AIA-PACK T4 | Tosoh Corp. | Mar 9, 1990 | SESE |
| K896865 | VITRO T4-EIA-XT | In Vitro Diagnostics, Inc. | Jan 30, 1990 | SESE |
| K896329 | D-CHEM TOTAL T4 TEST KIT FOR THYROXINE QUANTITA. | Photec Diagnostics, Inc. | Dec 12, 1989 | SESE |
| K892853 | T4 CLASP-BEAD EIA KIT | Biotecx Laboratories, Inc. | May 22, 1989 | SESE |
| K890831 | EMIT CONVENIENCE PACK: THYROXINE ASSAY | Syva Co. | Apr 14, 1989 | SESE |
| K884260 | THYROXINE MICROASSAY | Diamedix Corp. | Feb 23, 1989 | SESE |
| K885258 | ACA THYROXINE (T4 E) METHOD | The DU Pont Co. | Feb 17, 1989 | SESE |
| K885141 | EMIT THYROXINE ASSAY | Syva Co. | Feb 17, 1989 | SESE |
| K884700 | ANALYST THYROXINE (T4) ROTOR | The DU Pont Co. | Jan 27, 1989 | SESE |
| K884634 | MODIFIED CEDIA TOTAL T4 ASSAY | Microgenics Corp. | Dec 9, 1988 | SESE |
| K881357 | EMIT CONVENIENCE PACK: THYROXINE ASSAY | Syva Co. | May 27, 1988 | SESE |
| K880620 | EMIT THYROXINE ASSAY | Syva Co. | Mar 24, 1988 | SESE |
| K880662 | VISION(R) THYROXINE (T4) | Abbott Laboratories | Mar 16, 1988 | SESE |
| K874866 | T4 SEROZYME ENZYMEIMMUNOASSAY KIT/MAG. SOLID PHASE | Serono Diagnostics, Inc. | Feb 11, 1988 | SESE |
| K874603 | CIBA CORNING T4 LIPIA (LIPOSOME IMMUNOASSAY) | Ciba Corning Diagnostics Corp. | Dec 18, 1987 | SESE |
| K873976 | AMERLITE TT4 ASSAY (240/480/144 TEST KITS) | Amersham Corp. | Nov 5, 1987 | SESE |
| K873518 | AFFINITY TOTAL THYROXINE IMMUNIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | Oct 29, 1987 | SESE |
| K872192 | IMMUBEAD T4 ENZYME IMMUNOASSAY KIT | Immunotech Corp. | Aug 13, 1987 | SESE |
| K862233 | CIBA CORNING PRISMA T4 LIPIA (LIPOSOME) | Ciba Corning Diagnostics Corp. | Oct 14, 1986 | SESE |
| K854971 | V-TREND EIA T4 ENZYME IMMUNOASSAY TEST KIT | V-Tech, Inc. | Feb 6, 1986 | SESE |
| K852164 | CEDIA TOTAL T4 ASSAY | Microgenics Corp. | Jul 22, 1985 | SESE |
| K841601 | TERUMO SENSIBEAD THYROXINE EIA KIT | Terumo Medical Corp. | May 22, 1984 | SESE |
| K841576 | TECHNICON RA-1000 SYS T4-THYROXINE | Technicon Instruments Corp. | May 22, 1984 | SESE |
| K840473 | VENTREZYME T4 IMMUNOASSAY T4 | Vxr, Inc. | Apr 4, 1984 | SESE |
| K840241 | THYROXINE EMIA | Collaborative Research, Inc. | Mar 30, 1984 | SESE |
| K834102 | RA-1000 SYS-T4(THYROXINE)SERUM ANAL | Technicon Instruments Corp. | Mar 15, 1984 | SESE |
| K834210 | STRATUS TOTAL THYROXINE FLUOROMETRIC | American Dade | Mar 5, 1984 | SESE |
| K830683 | TDX THYROXINE | Abbott Laboratories | Apr 6, 1983 | SESE |
| K830769 | FEKAL CON-TRATE SYSTEM | Trend Scientific, Inc. | Apr 5, 1983 | SESE |
| K830136 | PARAMOUNT THYROXINE ASSAY | Syva Co. | Feb 7, 1983 | SESE |
| K823751 | SOPHEIA THYROXINE EIA KIT | Diagnostic Products Corp. | Jan 12, 1983 | SESE |
| K823034 | SYVA ADVANCE THYROXINE ASSAY | Syva Co. | Nov 8, 1982 | SESE |
| K820750 | ENZYMUNE-TEST T4 | Icl Scientific | Apr 6, 1982 | SESE |
| K810586 | EMIT-TFG PRISMA THYROXINE ASSAY | Syva Co. | Mar 17, 1981 | SESE |
| K802693 | OREIA-Q-TY, ENZYME IMMUNOASSAY | Organon, Inc. | Dec 10, 1980 | SESE |
| K801475 | APPLICATION OF EMIT AED ASSAYS | Syva Co. | Jul 8, 1980 | SESE |
| K801288 | EMIT AAII THYROXINE ASSAY | Syva Co. | Jun 30, 1980 | SESE |
| K800384 | SMAC SYSTEM, T4 METHOD | Technicon Instruments Corp. | Mar 19, 1980 | SESE |
| K790848 | A-GENT QUANTICHROM T4 11A | Abbott Laboratories | Aug 10, 1979 | SESE |
| K790686 | EMIT CFA THYROXINE ASSAY | Syva Co. | May 25, 1979 | SESE |
| K782085 | EMIT THYROXINE ASSAY | Syva Co. | Feb 1, 1979 | SESE |
| K781828 | COMPUTER, 3500, GILFORD SYSTEM | Syva Co. | Dec 4, 1978 | SESE |
| K770070 | ENIT ABA THYROXINE ASSAY | Syva Co. | Jan 21, 1977 | SESE |
Top Applicants
- Syva Co. — 14 clearances
- Microgenics Corp. — 6 clearances
- Technicon Instruments Corp. — 4 clearances
- Abbott Laboratories — 4 clearances
- The DU Pont Co. — 2 clearances
