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, Diagnostic Products Corp. and Diagnostic Systems Laboratories, 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 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 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 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 Jun 08, 2004
NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE, MODEL 62-7022
K040813
Nichols Institute Diagnostics
Chemistry · 70d
Cleared Apr 22, 2004
NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAY
K033727
Nichols Institute Diagnostics
Chemistry · 146d
Cleared Feb 12, 2004
LIAISON N-TACT PTH
K033426
DiaSorin, Inc.
Chemistry · 108d
Cleared Jan 26, 2004
NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040
K033302
Nichols Institute Diagnostics
Chemistry · 104d
Cleared Oct 09, 2002
PARATHYROID HORMONE TEST SYSTEM/NICHOLS ADVANTAGE QUICK-INTRAOPERATIVE BIO-INTACT PTH (1-84)
K022472
Nichols Institute Diagnostics
Chemistry · 75d
Cleared Aug 21, 2002
IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER
K022603
Diagnostic Products Corp.
Toxicology · 15d
Cleared May 31, 2002
AXSYM INTACT PTH, MODEL 2G06
K020945
Diagnostic Systems Laboratories, Inc.
Chemistry · 67d
Cleared Dec 13, 2001
NICHOLS ADVANTAGE CHEMILUMINESCENCE BIO-INTACT PARATHYROID HORMONE (1-84) IMMUNOASSAY
K013992
Nichols Institute Diagnostics
Chemistry · 9d
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

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.