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.
Recent Cleared Devices (20 of 86)
Showing 20 most recent of 86 cleared devices.
| 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 |
Top Applicants
- Syva Co. — 14 clearances
- Microgenics Corp. — 6 clearances
- Abbott Laboratories — 4 clearances
- Technicon Instruments Corp. — 4 clearances
- Bio-Rad — 2 clearances
