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..

86
Total
86
Cleared
95d
Avg days
1977
Since
Declining activity - 0 submissions in the last 2 years vs 3 in the prior period

FDA 510(k) Cleared Radioimmunoassay, Parathyroid Hormone Devices (Product Code CEW)

86 devices
1–24 of 86
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

About Product Code CEW - Regulatory Context

510(k) Submission Activity

86 total 510(k) submissions under product code CEW since 1977, with 86 receiving FDA clearance (average review time: 95 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 3 in the prior period.

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