CEC · Radioimmunoassay, Free Thyroxine
Clinical Chemistry · 21 CFR 862.1695 · Class 2
Overview
| Product Code | CEC |
|---|---|
| Device Name | Radioimmunoassay, Free Thyroxine |
| Regulation | 21 CFR 862.1695 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
A free thyroxine test system is a device intended to measure free (not protein bound) thyroxine (thyroid hormone) in serum or plasma. Levels of free thyroxine in plasma are thought to reflect the amount of thyroxine hormone available to the cells and may therefore determine the clinical metabolic status of thyroxine. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 92)
Showing 20 most recent of 92 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K240273 | Access Free T4 | Beckman Coulter, Inc. | Mar 6, 2024 | SESE |
| K220456 | Elecsys FT4 IV | Roche Diagnostics | Apr 7, 2023 | SESE |
| K182423 | MAGLUMI 2000 FT4 | Shenzhen New Industries Biomedical Engineering Co., Ltd. | Oct 4, 2018 | SESE |
| K181233 | Elecsys FT4 III | Roche Diagnostics | Sep 18, 2018 | SESE |
| K173122 | Abbott Architect Free T4 | Abbott Laboratories | Oct 27, 2017 | SESE |
| K152422 | FREND Free T4 Test System | Nanoentek USA, Inc. | Feb 17, 2016 | SESE |
| K132058 | VIDAS FT4 | Biomerieux S.A. | Jun 8, 2015 | SESE |
| K140859 | DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4, DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT | Siemens Healthcare Diagnostics, Inc. | Nov 26, 2014 | SESE |
| K140842 | DIMENSION LOCI FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4L, DIMENSION LOCI THYROID STIMULATING HORMONE FLEX REAGENT CART | Siemens Healthcare Diagnostics, Inc. | Nov 26, 2014 | SESE |
| K131244 | ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSET | Roche Diagnostics | Jan 27, 2014 | SESE |
| K132249 | ADVIA CENTAUR FT4, ADVIA CENTAUR T4 | Siemens Healthcare Diagnostics, Inc. | Sep 13, 2013 | SESE |
| K121951 | LIAISON FT4 LIAISON CONTROL THYROID 1 LIAISON CONTROL THYROID 2 LIAISON CONTROL THYROID 3 | DiaSorin, Inc. | Apr 4, 2013 | SESE |
| K123379 | ABBOTT ARCHITECT FREE T4 | Abbott Laboratories | Nov 27, 2012 | SESE |
| K083373 | IMMULITE 2000 FREE T4 | Siemens Healthcare Diagnostics, Inc. | Feb 2, 2009 | SESE |
| K080167 | ACS 180 AND ADVIA CENTAUR FT4 IMMUNOASSAYS | Siemens Healthcare Diagnostics | Aug 8, 2008 | SESE |
| K073604 | DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD | Dade Behring, Inc. | Mar 13, 2008 | SESE |
| K070708 | OLYMPUS FT4-FREE THYROXINE, OLYMPUS T4- TOTAL THYROXINE, MODEL# OSR210102, OSR210104 | Olympus Life & Material Science Europa GmbH (Irish | Aug 21, 2007 | SESE |
| K053531 | DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE AND LOCI 1 CALIBRATOR | Dade Behring, Inc. | Mar 3, 2006 | SESE |
| K030329 | FASTPACK FREE T4 IMMUNOASSAY | Qualigen, Inc. | Jul 3, 2003 | SESE |
| K020548 | FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300 | Monobind | Apr 5, 2002 | SESE |
Top Applicants
- Abbott Laboratories — 8 clearances
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 8 clearances
- Amersham Corp. — 5 clearances
- Siemens Healthcare Diagnostics, Inc. — 4 clearances
- Corning Medical & Scientific — 3 clearances
