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 Nichols Institute Diagnostics, Scantibodies Laboratory, Inc. and Diagnostic Products Corp..

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 Jan 31, 2017
IDS-iSYS Intact PTHN
K161158
Immunodiagnostic Systems , Ltd.
Chemistry · 281d
Cleared Jun 22, 2015
LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration Verifiers
K150879
DiaSorin, Inc.
Chemistry · 82d
Cleared Feb 05, 2014
ADVIA CENTAUR INTACT PARATHYROID HORMONE (IPTH) ASSAY
K133601
Siemens Healthcare Diagnostics, Inc.
Chemistry · 72d
Cleared Nov 08, 2013
LIAISON N-TACT PTH GEN II, CONTROL SET, CALIBRATION VERIFIERS
K132515
DiaSorin, Inc.
Chemistry · 88d
Cleared Mar 21, 2013
ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAY
K121981
Siemens Healthcare Diagnostics
Chemistry · 258d
Cleared Feb 03, 2012
IDS-ISYS INTACT PTH
K103325
Immunodiagnostic Systems , Ltd.
Chemistry · 448d
Cleared Oct 22, 2010
VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH REAGENT PACK, VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH CALIBRATORS, VIT
K101921
Ortho-Clinical Diagnostics
Chemistry · 105d
Cleared Jul 13, 2007
ROCHE ELECSYS PTH TEST SYSTEM
K070709
Roche Diagnostics Corp.
Chemistry · 121d
Cleared Jun 21, 2007
ST AIA-PACK INTACT PTH ASSAY
K063605
Tosoh Bioscience, Inc.
Chemistry · 199d
Cleared Jun 19, 2007
ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM, HIGH), MODELS 8K25-20, 8K25-25, 8K25-01
K063232
Biokit, S.A.
Chemistry · 237d
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 Mar 01, 2006
MODIFICATION TO WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILLUMINOMETRIC (ICMA) ASSAY KIT, MODEL 3KG002
K060420
Scantibodies Laboratory, Inc.
Chemistry · 12d
Cleared Feb 27, 2006
MODIFICATION TO: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT
K060348
Scantibodies Laboratory, Inc.
Chemistry · 17d
Cleared Oct 18, 2005
TOTAL INTACT PTH IMMUNORADIOMETRIC ASSAY (COATED TUBE VERSION), MODEL 3KG013
K051888
Scantibodies Laboratory, Inc.
Chemistry · 98d
Cleared Sep 09, 2005
WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC ASSAY (IRMA) COATED TUBE KIT, MODEL 3KG014
K051810
Scantibodies Laboratory, Inc.
Chemistry · 66d
Cleared Jul 26, 2005
WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILUMINOMETRIC ASSAY (ICMA), MODEL 3KG002
K051141
Scantibodies Laboratory, Inc.
Chemistry · 83d
Cleared Jul 26, 2005
TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT
K051150
Scantibodies Laboratory, Inc.
Chemistry · 83d
Cleared Jun 08, 2004
NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE, MODEL 62-7022
K040813
Nichols Institute Diagnostics
Chemistry · 70d

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.