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., Genalyte, Inc. and Siemens Healthcare Diagnostics.