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
Stable submission activity - 3 submissions in the last 2 years
Review times increasing: avg
210d
recently vs 84d historically
FDA 510(k) Cleared Radioimmunoassay, Thyroid-stimulating Hormone Devices (Product Code JLW)
242 devices
Cleared
Feb 06, 2026
Atellica® IM TSH3-Ultra II (TSH3ULII)
Siemens Healthcare Diagnostics, Inc.
Chemistry
262d
Cleared
Apr 25, 2025
Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL)
Siemens Healthcare Diagnostics
Chemistry
158d
Cleared
Jul 22, 2024
Maverick Diagnostic System TC1000
Genalyte, Inc.
Chemistry
209d
Cleared
Apr 04, 2024
ADVIA Centaur® TSH3-Ultra II (TSH3ULII)
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)
Siemens Healthcare Diagnostics, Inc.
Chemistry
360d
Cleared
Nov 10, 2022
Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer
Beckman Coulter, Inc.
Chemistry
196d
Cleared
Apr 16, 2019
Elecsys TSH
Roche Diagnostics
Chemistry
21d
Cleared
Jan 23, 2017
Elecsys TSH assay, cobas e 801 Immunoassay analyzer
Roche Diagnostics
Chemistry
126d
Cleared
Aug 18, 2016
Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems
Beckman Coulter, Inc.
Chemistry
241d
Cleared
Feb 27, 2006
DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT CARTRIDGE
Dade Behring, Inc.
Chemistry
46d
Cleared
Sep 16, 2004
MODIFICATION TO ACCESS HYPERSENSITIVE HTSH ASSAY
Beckman Coulter, Inc.
Chemistry
23d
Cleared
Nov 25, 2002
ACCESS HYPERSENSITIVE HTSH ASSAY
Beckman Coulter, Inc.
Chemistry
68d
Cleared
Nov 20, 1998
ABBOTT ARCHITECT TSH
Abbott Laboratories
Chemistry
51d
Cleared
Apr 29, 1998
ABBOTT AXSYM 3RD GENERATION TSH ASSAY
Abbott Laboratories
Chemistry
37d
Cleared
Jul 22, 1996
ELECSYS TSH ASSAY
Boehringer Mannheim Corp.
Chemistry
95d
Cleared
Jun 29, 1995
AXSYM ULTRASENSITIVE HTSH II
Abbott Laboratories
Chemistry
52d
Cleared
Mar 13, 1995
COAT-A-COUNT NEONATAL TSH IRMA
Diagnostic Products Corp.
Chemistry
251d
Cleared
Dec 19, 1994
IMMULITE RAPID TSH
Diagnostic Products Corp.
Chemistry
570d
Cleared
Dec 19, 1994
RADIAS NEONATAL TSH ENZYME IMMUNOASSAY
Bio-Rad
Chemistry
405d
Cleared
Dec 19, 1994
IMMULITE THIRD GENERATION (MODIFICATION)
Diagnostic Products Corp.
Chemistry
347d
Cleared
Aug 16, 1994
IMX ULTRASENSISTIVE HTSH II
Abbott Laboratories
Chemistry
77d
Cleared
Jun 21, 1994
AXSYM ULTRASENSITIVE HTSH
Abbott Laboratories
Chemistry
284d
Cleared
Apr 06, 1994
RADIAS 3RD GENERATION TSH IMMUNOASSAY
Bio-Rad
Chemistry
161d
Cleared
Dec 03, 1993
COBAS CORE TSH EIA
Roche Diagnostic Systems, Inc.
Chemistry
290d
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 remained relatively stable over the observed period, with 3 submissions in the last 24 months.
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 84 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 →