JLW · Radioimmunoassay, Thyroid-Stimulating Hormone
Clinical Chemistry · 21 CFR 862.1690 · Class 2
Overview
| Product Code | JLW |
|---|---|
| Device Name | Radioimmunoassay, Thyroid-Stimulating Hormone |
| Regulation | 21 CFR 862.1690 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
A thyroid stimulating hormone test system is a device intended to measure thyroid stimulating hormone, also known as thyrotrophin and thyrotrophic hormone, in serum and plasma. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 242)
Showing 20 most recent of 242 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251543 | Atellica® IM TSH3-Ultra II (TSH3ULII) | Siemens Healthcare Diagnostics, Inc. | Feb 6, 2026 | SESE |
| K243570 | Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L) | Siemens Healthcare Diagnostics | Apr 25, 2025 | SESE |
| K234091 | Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0 | Genalyte, Inc. | Jul 22, 2024 | SESE |
| K233050 | ADVIA Centaur® TSH3-Ultra II (TSH3ULII) | Siemens Healthcare Diagnostics, Inc. | Apr 4, 2024 | SESE |
| K222116 | Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP) | Siemens Healthcare Diagnostics, Inc. | Jul 13, 2023 | SESE |
| K221225 | Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer | Beckman Coulter, Inc. | Nov 10, 2022 | SESE |
| K190773 | Elecsys TSH | Roche Diagnostics | Apr 16, 2019 | SESE |
| K170232 | AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer | Boditech Med, Inc. | Oct 13, 2017 | SESE |
| K171103 | Lumipulse G TSH-III Immunoreaction Cartridges | Fujirebio Diagnostics,Inc. | Jul 28, 2017 | SESE |
| K162698 | MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer | Shenzhen New Industries Biomedical Engineering Co., Ltd. | Jul 14, 2017 | SESE |
| K162606 | Elecsys TSH assay, cobas e 801 Immunoassay analyzer | Roche Diagnostics | Jan 23, 2017 | SESE |
| K160541 | Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control | Sysmex America, Inc. | Oct 21, 2016 | SESE |
| K153651 | Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems | Beckman Coulter, Inc. | Aug 18, 2016 | SESE |
| K160647 | IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4 | Siemens Healthcare Diagnostics, Inc. | May 31, 2016 | SESE |
| K151792 | Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System | Siemens Healthcare Diagnostics, Inc. | Nov 20, 2015 | SESE |
| K150403 | ADVIA Centaur TSH3-Ultra | Siemens Healthcare Diagnostics, Inc. | May 1, 2015 | SESE |
| K141999 | ADVIA CENTAUR TSH | Siemens Healthcare Diagnostics, Inc. | Apr 22, 2015 | SESE |
| K131928 | FREND TSH (REAGENT CARTRIDGE) | Nanoentek USA, Inc. | Mar 14, 2014 | SESE |
| K130469 | LIAISON TSH, LIAISON CONTROL THYROID 1, LIAISON CONTROL THYROID 2, LIAISON CONTROL THYROID 3 | DiaSorin, Inc. | Apr 5, 2013 | SESE |
| K110761 | MICT TSH | Magnabiosciences, LLC | Mar 9, 2012 | SESE |
Top Applicants
- Abbott Laboratories — 10 clearances
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 9 clearances
- Bio-Rad — 9 clearances
- Diagnostic Products Corp. — 8 clearances
- Micromedic Systems — 8 clearances
