Product Code: CEW FDA class 2 21 CFR 862.1545

Radioimmunoassay, Parathyroid Hormone

Clinical Chemistry

The Parathyroid Hormone Radioimmunoassay is a clinical chemistry device that uses radioisotope-based immunoassay techniques to measure parathyroid hormone (PTH) levels in blood, used in the diagnosis and management of hyperparathyroidism, hypoparathyroidism, and calcium metabolism disorders. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is CEW, regulated under 21 CFR 862.1545, within the Clinical Chemistry medical specialty. This device is eligible for third-party review.

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FEI Numbers

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Basic Information

Product Code: CEW
Device Class: FDA class 2
Regulation Number: 862.1545
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 86 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K231927	Elecsys PTH , Elecsys PTH STAT	Mar 22, 2024	Substantially Equivalent	Roche Diagnostics
K232791	Access Intact PTH	Mar 01, 2024	Substantially Equivalent	Beckman Coulter, Inc.
K221197	VITROS Immunodiagnostic Products Intact PTH II Reagent Pack	Sep 05, 2023	Substantially Equivalent	Ortho Clinical Diagnostics
K190702	Lumipulse G whole PTH	Aug 30, 2019	Substantially Equivalent	Fujirebio Diagnostics,Inc.
K163658	ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay	May 23, 2017	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K161158	IDS-iSYS Intact PTHN	Jan 31, 2017	Substantially Equivalent	Immunodiagnostic Systems , Ltd.
K150879	LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration Verifiers	Jun 22, 2015	Substantially Equivalent	DiaSorin, Inc.
K133601	ADVIA CENTAUR INTACT PARATHYROID HORMONE (IPTH) ASSAY	Feb 05, 2014	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K132515	LIAISON N-TACT PTH GEN II, CONTROL SET, CALIBRATION VERIFIERS	Nov 08, 2013	Substantially Equivalent	DiaSorin, Inc.
K121981	ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAY	Mar 21, 2013	Substantially Equivalent	Siemens Healthcare Diagnostics
K103325	IDS-ISYS INTACT PTH	Feb 03, 2012	Substantially Equivalent	Immunodiagnostic Systems , Ltd.
K101921	VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH REAGENT PACK, VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH CALIBRATORS, VIT	Oct 22, 2010	Substantially Equivalent	Ortho-Clinical Diagnostics
K070709	ROCHE ELECSYS PTH TEST SYSTEM	Jul 13, 2007	Substantially Equivalent	Roche Diagnostics Corp.
K063605	ST AIA-PACK INTACT PTH ASSAY	Jun 21, 2007	Substantially Equivalent	Tosoh Bioscience, Inc.
K063232	ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM, HIGH), MODELS 8K25-20, 8K25-25, 8K25-01	Jun 19, 2007	Substantially Equivalent	Biokit, S.A.
K070391	ELECSYS PTH TEST SYSTEM	Mar 20, 2007	Substantially Equivalent	Roche Diagnostics Corp.
K061190	ACCESS INTACT PTH AND CALIBRATORS, MODELS A 16972 AND A 16953	Sep 15, 2006	Substantially Equivalent	Beckman Coulter, Inc.
K060420	MODIFICATION TO WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILLUMINOMETRIC (ICMA) ASSAY KIT, MODEL 3KG002	Mar 01, 2006	Substantially Equivalent	Scantibodies Laboratory, Inc.
K060348	MODIFICATION TO: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT	Feb 27, 2006	Substantially Equivalent	Scantibodies Laboratory, Inc.
K053533	IMMULITE/IMMULITE 1000 TURBO INTACT PTH	Feb 03, 2006	Substantially Equivalent	Diagnostic Products Corporation
K051888	TOTAL INTACT PTH IMMUNORADIOMETRIC ASSAY (COATED TUBE VERSION), MODEL 3KG013	Oct 18, 2005	Substantially Equivalent	Scantibodies Laboratory, Inc.
K051810	WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC ASSAY (IRMA) COATED TUBE KIT, MODEL 3KG014	Sep 09, 2005	Substantially Equivalent	Scantibodies Laboratory, Inc.
K051150	TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT	Jul 26, 2005	Substantially Equivalent	Scantibodies Laboratory, Inc.
K051141	WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILUMINOMETRIC ASSAY (ICMA), MODEL 3KG002	Jul 26, 2005	Substantially Equivalent	Scantibodies Laboratory, Inc.
K040813	NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE, MODEL 62-7022	Jun 08, 2004	Substantially Equivalent	Nichols Institute Diagnostics
K033727	NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAY	Apr 22, 2004	Substantially Equivalent	Nichols Institute Diagnostics
K033426	LIAISON N-TACT PTH	Feb 12, 2004	Substantially Equivalent	DiaSorin, Inc.
K033302	NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040	Jan 26, 2004	Substantially Equivalent	Nichols Institute Diagnostics
K031534	CYCLASE ACTIVATING PTH (CAP) IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG001	Jul 30, 2003	Substantially Equivalent	Scantibodies Laboratory, Inc.
K022472	PARATHYROID HORMONE TEST SYSTEM/NICHOLS ADVANTAGE QUICK-INTRAOPERATIVE BIO-INTACT PTH (1-84)	Oct 09, 2002	Substantially Equivalent	Nichols Institute Diagnostics
K022603	IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER	Aug 21, 2002	Substantially Equivalent	Diagnostic Products Corp.
K020945	AXSYM INTACT PTH, MODEL 2G06	May 31, 2002	Substantially Equivalent	Diagnostic Systems Laboratories, Inc.
K013992	NICHOLS ADVANTAGE CHEMILUMINESCENCE BIO-INTACT PARATHYROID HORMONE (1-84) IMMUNOASSAY	Dec 13, 2001	Substantially Equivalent	Nichols Institute Diagnostics
K013566	IMMULITE INTACT PTH, IMMULITE 2000 INTACT PTH, MODELS LKPP1 (100 TESTS), LKPP5 (500 TESTS), L2KPP2 (200 TESTS), L2KPP6	Nov 20, 2001	Substantially Equivalent	Diagnostic Products Corp.
K011505	IMMULITE INTACT PTH, MODEL LKPP1 (100 TESTS), LKPP5 (500 TESTS), IMMULITE 2000 INTACT PTH, MODEL L2KPP (200 TESTS), L2K6	Jul 02, 2001	Substantially Equivalent	Diagnostic Products Corp.
K004038	TOTAL PTH IMMUNORADIOMETRIC ASSAY(IRMA) DIAGNOSTIC KIT, MODEL 3KG600	Apr 30, 2001	Substantially Equivalent	Scantibodies Laboratory, Inc.
K001411	WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC IRMA DIAGNOSTIC ASSAY KIT, MODEL 3KG056	Aug 21, 2000	Substantially Equivalent	Scantibodies Laboratory, Inc.
K000471	FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT	Apr 11, 2000	Substantially Equivalent	Future Diagnostics B.V.
K992680	ELECSYS PARATHYROID HORMONE TEST SYSTEM	Sep 28, 1999	Substantially Equivalent	Roche Diagnostics Corp.
K992105	IMMULITE TURBO INTACT PTH, MODEL LSKPTZ	Jul 06, 1999	Substantially Equivalent	Diagnostic Products Corp.
K974306	SANGUI BIOTECH, INC. INTACT-PTH (PARATHYROID HORMONE) ELISA	Dec 23, 1997	Substantially Equivalent	Sangui Biotech, Inc.
K973514	ACTIVE INTACT PTH	Oct 31, 1997	Substantially Equivalent	Diagnostic Systems Laboratories, Inc.
K970483	AQUALITE INTACT PTH	Apr 14, 1997	Substantially Equivalent	Sealite Sciences, Inc.
K962598	NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE KIT	Dec 10, 1996	Substantially Equivalent	Nichols Institute Diagnostics
K962033	CHEMILUMINESCENCE INTRA-OPERATIVE INTACT PTH KIT	Sep 27, 1996	Substantially Equivalent	Nichols Institute Diagnostics
K954418	INTACT PARATHYROID HORMONE (PTH) IMMUNOASSAY (MODIFICATION)	Nov 03, 1995	Substantially Equivalent	Nichols Institute Diagnostics
K944788	INTACT PTH IMMUNORADIOMETRIC (IRMA) ASSAY (COATED BEAD-TECHNOLOGY)	Jul 19, 1995	Substantially Equivalent	Scantibodies Laboratory, Inc.
K952199	ACTIVE INTACT PTH ELISA	Jul 17, 1995	Substantially Equivalent	Diagnostic Systems Laboratories, Inc.
K950211	ELSA-PTH	Apr 13, 1995	Substantially Equivalent	Cis-Us, Inc.
K942369	GAMMA-BCT INTACT PTH	Sep 20, 1994	Substantially Equivalent	Immunodiagnostic Systems , Ltd.
K941878	OCTEIA INTACT PTH	Sep 07, 1994	Substantially Equivalent	I.D.S.
K934760	IMMUNLITE INTACT PTH	Dec 10, 1993	Substantially Equivalent	Diagnostic Products Corp.
K930008	COAT-A-COUNT INTACT PTH IRMA	Jun 15, 1993	Substantially Equivalent	Diagnostic Products Corp.
K921949	COTUBE PTH IRMA	Sep 02, 1992	Substantially Equivalent	Bio-Rad
K921629	N-TACT(R) PTH SP KIT	May 14, 1992	Substantially Equivalent	Incstar Corp.
K913434	VENTREX COATED TUBE INTACT PTH	Oct 25, 1991	Substantially Equivalent	Ventrex Laboratories, Inc.
K903130	LONDON DIAGNOSTICS LUMATAG(TM) INTACT PTH ASSAY	Sep 25, 1990	Substantially Equivalent	London Diagnostics, Inc.
K901711	PTH-MM II 125I RADIOIMMUNOASSAY (RIA)	Jul 16, 1990	Substantially Equivalent	Incstar Corp.
K896294	DSL I-PTH (DSL #8000)	Nov 21, 1989	Substantially Equivalent	Diagnostic Systems Laboratories, Inc.
K882560	CIBA CORNING MAGIC LITE INTACT PTH IMMUNOASSAY	Oct 13, 1988	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K874299	N-TACT PTH BY IMMUNORADIOMETRIC ASSAY (IRMA)	Nov 23, 1987	Substantially Equivalent	Incstar Corp.
K871970	DOUBLE ANTIBODY ULTRA-PTH #KPTD1 AND KPTD2	Sep 25, 1987	Substantially Equivalent	Diagnostic Products Corp.
K861797	ALLEGRO INTACT PARATHYROID HORMONE IMMUNOASSAY	Jul 22, 1986	Substantially Equivalent	Nichols Institute Diagnostics
K853784	C-TERMINAL PTH RIA KIT	Oct 04, 1985	Substantially Equivalent	Diagnostic Systems Laboratories, Inc.
K844735	PTH-RIA	Apr 29, 1985	Substantially Equivalent	Syncor Intl. Corp.
K850254	PARATHYROID HORMONE RADIOIMMUNOASSAY KIT	Apr 03, 1985	Substantially Equivalent	Cambridge Medical Technology
K843871	PARATHYROID HORMONE C-TERMINAL RIA KIT	Oct 30, 1984	Substantially Equivalent	Diagnostic Products Corp.
K843870	PARATHYROID HORMONE MID-MOLECULE RIA-KIT	Oct 30, 1984	Substantially Equivalent	Diagnostic Products Corp.
K843685	C-TERMINAL/MID-MOLECULE PARATHYROID -	Oct 11, 1984	Substantially Equivalent	Nichols Institute Diagnostics
K840379	PARATHYROID HORMONE ANALYSIS PRODUCT	Apr 04, 1984	Substantially Equivalent	Nichols Institute Diagnostics
K833768	C. PTH RADIOIMMUNOASSAY KIT-CPTHK	Dec 29, 1983	Substantially Equivalent	Sorin Biomedica, Fiat, USA, Inc.
K831470	PTH MR	Jun 22, 1983	Substantially Equivalent	Ramco Laboratories, Inc.
K831069	DAC-CEL PTH KIT RD51	Jun 16, 1983	Substantially Equivalent	Wellcome Diagnostics
K830664	HUMAN INTRACT PARATHYROID HORMONE BY	May 09, 1983	Substantially Equivalent	Immuno Nuclear Corp.
K830700	MMH PTH RIA KIT	Apr 06, 1983	Substantially Equivalent	Diagnostic Systems
K822944	GAMMA DAB[125I]PTH RADIOIMMUNOASSAY KIT	Dec 30, 1982	Substantially Equivalent	Travenol Laboratories, S.A.
K821131	RADIOIMMUNOASSAY PARATHYROID HORMONE MID	Jun 02, 1982	Substantially Equivalent	Endocrine-Metabolic Center
K820228	MIN-MOLECULE PTH BY RADIOIMMUNOASSAY	Mar 11, 1982	Substantially Equivalent	Immuno Nuclear Corp.
K813203	C-TERMINAL PTH RIA TEST KIT, DSL-1000	Dec 03, 1981	Substantially Equivalent	Diagnostic Systems Laboratories, Inc.
K811566	C-TERMINAL PTH BY RADIOIMMUNOASSAY KIT	Jun 25, 1981	Substantially Equivalent	Immuno Nuclear Corp.
K811418	N-TERMINAL HPTH BY RIA	Jun 24, 1981	Substantially Equivalent	Immuno Nuclear Corp.
K791128	PTH RIA 200	Sep 27, 1979	Substantially Equivalent	Institut National Des Radioelements
K782081	RIA SYSTEM, PARATHYROID HORMONE	Mar 21, 1979	Substantially Equivalent	Iso-Tex Diagnostics
K782010	HORMONE KIT, PARATHYROID	Jan 10, 1979	Substantially Equivalent	Nichols Institute Diagnostics
K772249	COMPLEMENT C3 NEPHELOMETRIC ASSAY	Dec 22, 1977	Substantially Equivalent	Kallestad Laboratories, Inc.
K771783	PTH RIA	Oct 14, 1977	Substantially Equivalent	Nichols Institute Diagnostics