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
86 devices
25–48 of 86
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 Jul 30, 2003
CYCLASE ACTIVATING PTH (CAP) IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG001
K031534
Scantibodies Laboratory, Inc.
Chemistry · 75d
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 Apr 30, 2001
TOTAL PTH IMMUNORADIOMETRIC ASSAY(IRMA) DIAGNOSTIC KIT, MODEL 3KG600
K004038
Scantibodies Laboratory, Inc.
Chemistry · 123d
Cleared Aug 21, 2000
WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC IRMA DIAGNOSTIC ASSAY KIT, MODEL 3KG056
K001411
Scantibodies Laboratory, Inc.
Chemistry · 109d
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 23, 1997
SANGUI BIOTECH, INC. INTACT-PTH (PARATHYROID HORMONE) ELISA
K974306
Sangui Biotech, Inc.
Chemistry · 36d
Cleared Oct 31, 1997
ACTIVE INTACT PTH
K973514
Diagnostic Systems Laboratories, Inc.
Chemistry · 44d
Cleared Apr 14, 1997
AQUALITE INTACT PTH
K970483
Sealite Sciences, Inc.
Chemistry · 63d
Cleared Dec 10, 1996
NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE KIT
K962598
Nichols Institute Diagnostics
Chemistry · 161d
Cleared Sep 27, 1996
CHEMILUMINESCENCE INTRA-OPERATIVE INTACT PTH KIT
K962033
Nichols Institute Diagnostics
Chemistry · 126d
Cleared Nov 03, 1995
INTACT PARATHYROID HORMONE (PTH) IMMUNOASSAY (MODIFICATION)
K954418
Nichols Institute Diagnostics
Chemistry · 42d
Cleared Jul 19, 1995
INTACT PTH IMMUNORADIOMETRIC (IRMA) ASSAY (COATED BEAD-TECHNOLOGY)
K944788
Scantibodies Laboratory, Inc.
Chemistry · 294d
Cleared Jul 17, 1995
ACTIVE INTACT PTH ELISA
K952199
Diagnostic Systems Laboratories, Inc.
Chemistry · 68d
Cleared Sep 20, 1994
GAMMA-BCT INTACT PTH
K942369
Immunodiagnostic Systems , Ltd.
Chemistry · 125d
Cleared Dec 10, 1993
IMMUNLITE INTACT PTH
K934760
Diagnostic Products Corp.
Chemistry · 67d