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 Siemens Healthcare Diagnostics, Inc., Beckman Coulter, Inc. and Genalyte, Inc..
FDA 510(k) Cleared Radioimmunoassay, Thyroid-stimulating Hormone Devices (Product Code JLW)
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 Review Time
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 →