JLW · Class II · 21 CFR 862.1690

FDA Product Code JLW: Radioimmunoassay, Thyroid-stimulating Hormone

Thyroid-stimulating hormone measurement is the primary screening test for thyroid dysfunction. FDA product code JLW covers radioimmunoassay systems for TSH quantification.

These assays measure TSH levels in serum to screen for hypothyroidism and hyperthyroidism, monitor thyroid hormone replacement therapy, and evaluate pituitary-thyroid axis function. TSH radioimmunoassays were the precursors to modern immunometric assays used today.

JLW devices are Class II medical devices, regulated under 21 CFR 862.1690 and reviewed by the FDA Chemistry panel.

Leading manufacturers include Abbott Laboratories, Bd Becton Dickinson Vacutainer Systems Preanalytic and Bio-Rad.

242
Total
242
Cleared
86d
Avg days
1976
Since
Declining activity - 2 submissions in the last 2 years vs 4 in the prior period
Review times increasing: avg 210d recently vs 85d historically

FDA 510(k) Cleared Radioimmunoassay, Thyroid-stimulating Hormone Devices (Product Code JLW)

242 devices
1–24 of 242
Cleared Feb 06, 2026
Atellica® IM TSH3-Ultra II (TSH3ULII)
K251543
Siemens Healthcare Diagnostics, Inc.
Chemistry · 262d
Cleared Apr 25, 2025
Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL)
K243570
Siemens Healthcare Diagnostics
Chemistry · 158d
Cleared Jul 22, 2024
Maverick Diagnostic System TC1000
K234091
Genalyte, Inc.
Chemistry · 209d
Cleared Apr 04, 2024
ADVIA Centaur® TSH3-Ultra II (TSH3ULII)
K233050
Siemens Healthcare Diagnostics, Inc.
Chemistry · 192d
Cleared Jul 13, 2023
Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP)
K222116
Siemens Healthcare Diagnostics, Inc.
Chemistry · 360d
Cleared Nov 10, 2022
Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer
K221225
Beckman Coulter, Inc.
Chemistry · 196d
Cleared Apr 16, 2019
Elecsys TSH
K190773
Roche Diagnostics
Chemistry · 21d
Cleared Jul 28, 2017
Lumipulse G TSH-III Immunoreaction Cartridges
K171103
Fujirebio Diagnostics,Inc.
Chemistry · 106d
Cleared Jan 23, 2017
Elecsys TSH assay, cobas e 801 Immunoassay analyzer
K162606
Roche Diagnostics
Chemistry · 126d
Cleared Aug 18, 2016
Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems
K153651
Beckman Coulter, Inc.
Chemistry · 241d
Cleared May 31, 2016
IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4
K160647
Siemens Healthcare Diagnostics, Inc.
Chemistry · 85d
Cleared Nov 20, 2015
Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System
K151792
Siemens Healthcare Diagnostics, Inc.
Chemistry · 142d
Cleared May 01, 2015
ADVIA Centaur TSH3-Ultra
K150403
Siemens Healthcare Diagnostics, Inc.
Chemistry · 72d
Cleared Apr 22, 2015
ADVIA CENTAUR TSH
K141999
Siemens Healthcare Diagnostics, Inc.
Chemistry · 273d
Cleared Apr 05, 2013
LIAISON TSH, LIAISON CONTROL THYROID 1, LIAISON CONTROL THYROID 2, LIAISON CONTROL THYROID 3
K130469
DiaSorin, Inc.
Chemistry · 39d
Cleared May 08, 2009
ADVIA CENTAUR TSH3-ULTRA METHOD
K083844
Siemens Healthcare Diagnostics
Chemistry · 135d
Cleared Dec 22, 2008
VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 3600 IMMUNODIAGNOSTIC SYSTEM
K083173
Ortho-Clinical Diagnostics
Chemistry · 56d
Cleared Oct 23, 2008
VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 5600 INTEGRATED SYSTEM
K081543
Ortho-Clinical Diagnostics, Inc.
Chemistry · 143d
Cleared May 23, 2008
DIMENSION TSHL FLEX REAGENT CARTRIDGE AND TSH SAMPLE DILUENT WITH MODELS RF 612 AND KD691
K081074
Siemens Healthcare Diagnostics, Inc.
Chemistry · 37d
Cleared Nov 29, 2006
OLYMPUS TSH REAGENT, CALIBRATOR AND CONTROL AND AU3000I IMMUNOASSAY SYSTEM
K062581
Olympus America, Inc.
Chemistry · 90d
Cleared Feb 27, 2006
DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT CARTRIDGE
K060090
Dade Behring, Inc.
Chemistry · 46d
Cleared Sep 16, 2004
MODIFICATION TO ACCESS HYPERSENSITIVE HTSH ASSAY
K042281
Beckman Coulter, Inc.
Chemistry · 23d
Cleared Jul 14, 2004
TSH-CTK-3 IRMA
K041014
DiaSorin, Inc.
Chemistry · 85d
Cleared Nov 25, 2002
ACCESS HYPERSENSITIVE HTSH ASSAY
K023093
Beckman Coulter, Inc.
Chemistry · 68d

About Product Code JLW - Regulatory Context

510(k) Submission Activity

242 total 510(k) submissions under product code JLW since 1976, with 242 receiving FDA clearance (average review time: 86 days).

Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 4 in the prior period.

FDA 510(k) Review Time - JLW Product Code

Recent submissions under JLW have taken an average of 210 days to reach a decision - up from 85 days historically. Manufacturers should account for longer review timelines in current project planning.

JLW devices are reviewed by the Chemistry panel. Browse all Chemistry devices →