CEW · Class II · 21 CFR 862.1545

FDA Product Code CEW: Radioimmunoassay, Parathyroid Hormone

Parathyroid hormone measurement is essential in the management of calcium disorders. FDA product code CEW covers radioimmunoassay systems for parathyroid hormone quantification.

These assays measure PTH levels in serum for the diagnosis and monitoring of hyperparathyroidism, hypoparathyroidism, and metabolic bone disease. Intraoperative PTH monitoring is used to confirm successful parathyroid adenoma removal during parathyroidectomy.

CEW devices are Class II medical devices, regulated under 21 CFR 862.1545 and reviewed by the FDA Immunology panel.

Leading manufacturers include Ortho-Clinical Diagnostics, Roche Diagnostics and Beckman Coulter, Inc..

3
Total
3
Cleared
312d
Avg days
2023
Since

List of Radioimmunoassay, Parathyroid Hormone devices cleared through 510(k)

3 devices
1–3 of 3
Cleared Mar 22, 2024
Elecsys PTH , Elecsys PTH STAT
K231927
Roche Diagnostics
Chemistry · 266d
Cleared Mar 01, 2024
Access Intact PTH
K232791
Beckman Coulter, Inc.
Chemistry · 172d
Cleared Sep 05, 2023
VITROS Immunodiagnostic Products Intact PTH II Reagent Pack
K221197
Ortho-Clinical Diagnostics
Chemistry · 498d

How to use this database

This page lists all FDA 510(k) submissions for Radioimmunoassay, Parathyroid Hormone devices (product code CEW). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Chemistry FDA review panel. Browse all Chemistry devices →