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 Diagnostic Products Corp., Roche Diagnostics Corp. 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
Cleared Aug 30, 2019
Lumipulse G whole PTH
K190702
Fujirebio Diagnostics,Inc.
Chemistry · 165d
Cleared May 23, 2017
ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay
K163658
Siemens Healthcare Diagnostics, Inc.
Chemistry · 151d
Cleared Jul 13, 2007
ROCHE ELECSYS PTH TEST SYSTEM
K070709
Roche Diagnostics Corp.
Chemistry · 121d
Cleared Mar 20, 2007
ELECSYS PTH TEST SYSTEM
K070391
Roche Diagnostics Corp.
Chemistry · 39d
Cleared Sep 15, 2006
ACCESS INTACT PTH AND CALIBRATORS, MODELS A 16972 AND A 16953
K061190
Beckman Coulter, Inc.
Chemistry · 140d
Cleared Aug 21, 2002
IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER
K022603
Diagnostic Products Corp.
Toxicology · 15d
Cleared Nov 20, 2001
IMMULITE INTACT PTH, IMMULITE 2000 INTACT PTH, MODELS LKPP1 (100 TESTS), LKPP5 (500 TESTS), L2KPP2 (200 TESTS), L2KPP6
K013566
Diagnostic Products Corp.
Chemistry · 25d
Cleared Jul 02, 2001
IMMULITE INTACT PTH, MODEL LKPP1 (100 TESTS), LKPP5 (500 TESTS), IMMULITE 2000 INTACT PTH, MODEL L2KPP (200 TESTS), L2K6
K011505
Diagnostic Products Corp.
Chemistry · 47d
Cleared Sep 28, 1999
ELECSYS PARATHYROID HORMONE TEST SYSTEM
K992680
Roche Diagnostics Corp.
Chemistry · 49d
Cleared Jul 06, 1999
IMMULITE TURBO INTACT PTH, MODEL LSKPTZ
K992105
Diagnostic Products Corp.
Chemistry · 14d
Cleared Dec 10, 1993
IMMUNLITE INTACT PTH
K934760
Diagnostic Products Corp.
Chemistry · 67d
Cleared Jun 15, 1993
COAT-A-COUNT INTACT PTH IRMA
K930008
Diagnostic Products Corp.
Chemistry · 162d
Cleared Sep 02, 1992
COTUBE PTH IRMA
K921949
Bio-Rad
Chemistry · 128d
Cleared Sep 25, 1987
DOUBLE ANTIBODY ULTRA-PTH #KPTD1 AND KPTD2
K871970
Diagnostic Products Corp.
Chemistry · 127d
Cleared Oct 30, 1984
PARATHYROID HORMONE MID-MOLECULE RIA-KIT
K843870
Diagnostic Products Corp.
Chemistry · 28d
Cleared Oct 30, 1984
PARATHYROID HORMONE C-TERMINAL RIA KIT
K843871
Diagnostic Products Corp.
Chemistry · 28d

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.