Radioimmunoassay, Parathyroid Hormone
FDA product code CEW · Class II (moderate risk) · 21 CFR 862.1545 · Clinical Chemistry
86510(k) clearances
0PMA approvals
17recalls
Manufacturers
- Nichols Institute Diagnostics 13
- Scantibodies Laboratory, Inc. 10
- Diagnostic Products Corp. 10
- Diagnostic Systems Laboratories, Inc. 6
- Immuno Nuclear Corp. 4
- Roche Diagnostics Corp. 4
- Immunodiagnostic Systems , Ltd. 3
- DiaSorin, Inc. 3
- Siemens Healthcare Diagnostics, Inc. 3
- Incstar Corp. 3
- Ortho-Clinical Diagnostics 2
- Beckman Coulter Inc. 2
- Ramco Laboratories, Inc. 1
- Fujirebio Diagnostics,Inc. 1
- London Diagnostics, Inc. 1
- Cambridge Medical Technology 1
- Sorin Biomedica, Fiat, USA, Inc. 1
- Diagnostic Systems 1
- Travenol Laboratories, S.A. 1
- Institut National Des Radioelements 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K231927 | Elecsys PTH , Elecsys PTH STATCEW · Traditional | Roche Diagnostics | 03/22/2024SE |
| K232791 | Access Intact PTHCEW · Traditional | Beckman Coulter, Inc. | 03/01/2024SE |
| K221197 | VITROS Immunodiagnostic Products Intact PTH II Reagent PackCEW · Traditional | Ortho Clinical Diagnostics | 09/05/2023SE |
| K190702 | Lumipulse G whole PTHCEW · Traditional | Fujirebio Diagnostics,Inc. | 08/30/2019SE |
| K163658 | ADVIA Centaur Intact Parathyroid Hormone (PTH) AssayCEW · Traditional | Siemens Healthcare Diagnostics, Inc. | 05/23/2017SE |
| K161158 | IDS-iSYS Intact PTHNCEW · Traditional | Immunodiagnostic Systems , Ltd. | 01/31/2017SE |
| K150879 | LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration VerifiersCEW · Traditional | DiaSorin, Inc. | 06/22/2015SE |
| K133601 | Advia Centaur Intact Parathyroid Hormone (Ipth) AssayCEW · Traditional | Siemens Healthcare Diagnostics, Inc. | 02/05/2014SE |
| K132515 | Liaison N-Tact PTH Gen II, Control Set, Calibration VerifiersCEW · Traditional | DiaSorin, Inc. | 11/08/2013SE |
| K121981 | Advia Centaur Inact Parathyroid Hormone (Ipth) AssayCEW · Traditional | Siemens Healthcare Diagnostics | 03/21/2013SE |
| K103325 | Ids-Isys Intact PTHCEW · Traditional | Immunodiagnostic Systems , Ltd. | 02/03/2012SE |
| K101921 | Vitros Immunodiagnostics Products Intact PTH Reagent Pack, Vitros Immunodiagnostics…CEW · Traditional | Ortho-Clinical Diagnostics | 10/22/2010SE |
| K070709 | Roche Elecsys PTH Test SystemCEW · Traditional | Roche Diagnostics Corp. | 07/13/2007SE |
| K063605 | ST Aia-Pack Intact PTH AssayCEW · Traditional | Tosoh Bioscience, Inc. | 06/21/2007SE |
| K063232 | Architect Intact PTH Reagents, Calibrators (A-F) and Controls (Low, Medium, High)…CEW · Traditional | Biokit, S.A. | 06/19/2007SE |
| K070391 | Elecsys PTH Test SystemCEW · Special | Roche Diagnostics Corp. | 03/20/2007SE |
| K061190 | Access Intact PTH and Calibrators, Models a 16972 and a 16953CEW · Traditional | Beckman Coulter, Inc. | 09/15/2006SE |
| K060420 | Modification to Whole PTH (1-84) Specific Immunochemilluminometric (Icma) Assay Kit…CEW · Special | Scantibodies Laboratory, Inc. | 03/01/2006SE |
| K060348 | Modification to: Total Intact PTH Immunochemiluminometric (Icma) Assay KitCEW · Special | Scantibodies Laboratory, Inc. | 02/27/2006SE |
| K053533 | Immulite/Immulite 1000 Turbo Intact PTHCEW · Traditional | Diagnostic Products Corporation | 02/03/2006SE |
| K051888 | Total Intact PTH Immunoradiometric Assay (Coated Tube Version), Model 3KG013CEW · Traditional | Scantibodies Laboratory, Inc. | 10/18/2005SE |
| K051810 | Whole PTH (1-84) Specific Immunoradiometric Assay (Irma) Coated Tube Kit, Model 3KG014CEW · Traditional | Scantibodies Laboratory, Inc. | 09/09/2005SE |
| K051150 | Total Intact PTH Immunochemiluminometric (Icma) Assay KitCEW · Traditional | Scantibodies Laboratory, Inc. | 07/26/2005SE |
| K051141 | Whole PTH (1-84) Specific Immunochemiluminometric Assay (Icma), Model 3KG002CEW · Traditional | Scantibodies Laboratory, Inc. | 07/26/2005SE |
| K040813 | Nichols Advantage Chemiluminescence Intact Parathyroid Hormone, Model 62-7022CEW · Traditional | Nichols Institute Diagnostics | 06/08/2004SE |
| K033727 | Nichols Advantage Bio-Intact PTH (1-84) ImmunoassayCEW · Traditional | Nichols Institute Diagnostics | 04/22/2004SE |
| K033426 | Liaison N-Tact PTHCEW · Traditional | DiaSorin, Inc. | 02/12/2004SE |
| K033302 | Nichols Advantage Bio-Intact PTH (1-84) Assay, Model 62-7040CEW · Special | Nichols Institute Diagnostics | 01/26/2004SE |
| K031534 | Cyclase Activating PTH (Cap) Immunoradiometric (Irma) Assay Kit, Model 3KG001CEW · Traditional | Scantibodies Laboratory, Inc. | 07/30/2003SE |
| K022472 | Parathyroid Hormone Test System/Nichols Advantage Quick-Intraoperative Bio-Intact PTH…CEW · Traditional | Nichols Institute Diagnostics | 10/09/2002SE |
| K022603 | Immulite 1000 Automated Immunoassay AnalyzerCEW · Special | Diagnostic Products Corp. | 08/21/2002SE |
| K020945 | Axsym Intact PTH, Model 2G06CEW · Traditional | Diagnostic Systems Laboratories, Inc. | 05/31/2002SE |
| K013992 | Nichols Advantage Chemiluminescence Bio-Intact Parathyroid Hormone (1-84) ImmunoassayCEW · Traditional | Nichols Institute Diagnostics | 12/13/2001SE |
| K013566 | Immulite Intact PTH, Immulite 2000 Intact PTH, Models LKPP1 (100 Tests), LKPP5 (500…CEW · Special | Diagnostic Products Corp. | 11/20/2001SE |
| K011505 | Immulite Intact PTH, Model LKPP1 (100 Tests), LKPP5 (500 Tests), Immulite 2000 Intact…CEW · Traditional | Diagnostic Products Corp. | 07/02/2001SE |
| K004038 | Total PTH Immunoradiometric Assay(Irma) Diagnostic Kit, Model 3KG600CEW · Traditional | Scantibodies Laboratory, Inc. | 04/30/2001SE |
| K001411 | Whole PTH (1-84) Specific Immunoradiometric Irma Diagnostic Assay Kit, Model 3KG056CEW · Traditional | Scantibodies Laboratory, Inc. | 08/21/2000SE |
| K000471 | Future Diagnostics B.V. Stat-Intraoperative Intact PTH KitCEW · Traditional | Future Diagnostics B.V. | 04/11/2000SE |
| K992680 | Elecsys Parathyroid Hormone Test SystemCEW · Traditional | Roche Diagnostics Corp. | 09/28/1999SE |
| K992105 | Immulite Turbo Intact PTH, Model LskptzCEW · Special | Diagnostic Products Corp. | 07/06/1999SE |
| K974306 | Sangui Biotech, Inc. Intact-Pth (Parathyroid Hormone) ElisaCEW · Traditional | Sangui Biotech, Inc. | 12/23/1997SE |
| K973514 | Active Intact PTHCEW · Traditional | Diagnostic Systems Laboratories, Inc. | 10/31/1997SE |
| K970483 | Aqualite Intact PTHCEW · Traditional | Sealite Sciences, Inc. | 04/14/1997SE |
| K962598 | Nichols Advantage Chemiluminescence Intact Parathyroid Hormone KitCEW · Traditional | Nichols Institute Diagnostics | 12/10/1996SE |
| K962033 | Chemiluminescence Intra-Operative Intact PTH KitCEW · Traditional | Nichols Institute Diagnostics | 09/27/1996SE |
| K954418 | Intact Parathyroid Hormone (PTH) Immunoassay (Modification)CEW · Traditional | Nichols Institute Diagnostics | 11/03/1995SE |
| K944788 | Intact PTH Immunoradiometric (Irma) Assay (Coated Bead-Technology)CEW · Traditional | Scantibodies Laboratory, Inc. | 07/19/1995SE |
| K952199 | Active Intact PTH ElisaCEW · Traditional | Diagnostic Systems Laboratories, Inc. | 07/17/1995SE |
| K950211 | Elsa-PthCEW · Traditional | Cis-Us, Inc. | 04/13/1995SE |
| K942369 | Gamma-Bct Intact PTHCEW · Traditional | Immunodiagnostic Systems , Ltd. | 09/20/1994SE |
| K941878 | Octeia Intact PTHCEW · Traditional | I.D.S. | 09/07/1994SE |
| K934760 | Immunlite Intact PTHCEW · Traditional | Diagnostic Products Corp. | 12/10/1993SE |
| K930008 | Coat-A-Count Intact PTH IrmaCEW · Traditional | Diagnostic Products Corp. | 06/15/1993SE |
| K921949 | Cotube PTH IrmaCEW · Traditional | Bio-Rad | 09/02/1992SE |
| K921629 | N-Tact(R) PTH SP KitCEW · Traditional | Incstar Corp. | 05/14/1992SE |
| K913434 | Ventrex Coated Tube Intact PTHCEW · Traditional | Ventrex Laboratories, Inc. | 10/25/1991SE |
| K903130 | London Diagnostics Lumatag(Tm) Intact PTH AssayCEW · Traditional | London Diagnostics, Inc. | 09/25/1990SE |
| K901711 | Pth-Mm II 125I Radioimmunoassay (Ria)CEW · Traditional | Incstar Corp. | 07/16/1990SE |
| K896294 | DSL I-Pth (DSL #8000)CEW · Traditional | Diagnostic Systems Laboratories, Inc. | 11/21/1989SE |
| K882560 | Ciba Corning Magic Lite Intact PTH ImmunoassayCEW · Traditional | Ciba Corning Diagnostics Corp. | 10/13/1988SE |
| K874299 | N-Tact PTH by Immunoradiometric Assay (Irma)CEW · Traditional | Incstar Corp. | 11/23/1987SE |
| K871970 | Double Antibody Ultra-Pth #KPTD1 and KPTD2CEW · Traditional | Diagnostic Products Corp. | 09/25/1987SE |
| K861797 | Allegro Intact Parathyroid Hormone ImmunoassayCEW · Traditional | Nichols Institute Diagnostics | 07/22/1986SE |
| K853784 | C-Terminal PTH Ria KitCEW · Traditional | Diagnostic Systems Laboratories, Inc. | 10/04/1985SE |
| K844735 | Pth-RiaCEW · Traditional | Syncor Intl. Corp. | 04/29/1985SE |
| K850254 | Parathyroid Hormone Radioimmunoassay KitCEW · Traditional | Cambridge Medical Technology | 04/03/1985SE |
| K843871 | Parathyroid Hormone C-Terminal Ria KitCEW · Traditional | Diagnostic Products Corp. | 10/30/1984SE |
| K843870 | Parathyroid Hormone Mid-Molecule Ria-KitCEW · Traditional | Diagnostic Products Corp. | 10/30/1984SE |
| K843685 | C-Terminal/Mid-Molecule Parathyroid -CEW · Traditional | Nichols Institute Diagnostics | 10/11/1984SE |
| K840379 | Parathyroid Hormone Analysis ProductCEW · Traditional | Nichols Institute Diagnostics | 04/04/1984SE |
| K833768 | C. PTH Radioimmunoassay Kit-CpthkCEW · Traditional | Sorin Biomedica, Fiat, USA, Inc. | 12/29/1983SE |
| K831470 | PTH MRCEW · Traditional | Ramco Laboratories, Inc. | 06/22/1983SE |
| K831069 | Dac-Cel PTH Kit RD51CEW · Traditional | Wellcome Diagnostics | 06/16/1983SE |
| K830664 | Human Intract Parathyroid Hormone byCEW · Traditional | Immuno Nuclear Corp. | 05/09/1983SE |
| K830700 | MMH PTH Ria KitCEW · Traditional | Diagnostic Systems | 04/06/1983SE |
| K822944 | Gamma DAB[125I]PTH Radioimmunoassay KitCEW · Traditional | Travenol Laboratories, S.A. | 12/30/1982SE |
| K821131 | Radioimmunoassay Parathyroid Hormone MidCEW · Traditional | Endocrine-Metabolic Center | 06/02/1982SE |
| K820228 | Min-Molecule PTH by RadioimmunoassayCEW · Traditional | Immuno Nuclear Corp. | 03/11/1982SE |
| K813203 | C-Terminal PTH Ria Test Kit, DSL-1000CEW · Traditional | Diagnostic Systems Laboratories, Inc. | 12/03/1981SE |
| K811566 | C-Terminal PTH by Radioimmunoassay KitCEW · Traditional | Immuno Nuclear Corp. | 06/25/1981SE |
| K811418 | N-Terminal HPTH by RiaCEW · Traditional | Immuno Nuclear Corp. | 06/24/1981SE |
| K791128 | PTH Ria 200CEW · Traditional | Institut National Des Radioelements | 09/27/1979SE |
| K782081 | Ria System, Parathyroid HormoneCEW · Traditional | Iso-Tex Diagnostics | 03/21/1979SE |
| K782010 | Hormone Kit, ParathyroidCEW · Traditional | Nichols Institute Diagnostics | 01/10/1979SE |
| K772249 | Complement C3 Nephelometric AssayCEW · Traditional | Kallestad Laboratories, Inc. | 12/22/1977SE |
| K771783 | PTH RiaCEW · Traditional | Nichols Institute Diagnostics | 10/14/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0366-2026 Class II | Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN): (1)…The potential for falsely depressed Intact PTH patient results at the low end of the assay range, less than… | Siemens Healthcare Diagnostics, Inc. | 09/22/2025Open, Classified |
| Z-0803-2025 Class II | Access Intact PTH assay, a paramagnetic particle, chemiluminescent immunoassay for the…Beckman Coulter has identified that some Access PTH reagent packs from lot 339071 may be over- or… | Beckman Coulter, Inc. | 11/26/2024Open, Classified |
| Z-0673-2025 Class II | Access Intact PTH assay on the DxI 9000 Access Immunoassay Analyzer, Catalog number…The reason for the recall is that EDTA and lithium heparin plasma samples that are stored in the DxI 9000… | Beckman Coulter Inc. | 11/08/2024Open, Classified |
| Z-1016-2023 Class II | Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF…Due to an issue of high coefficient of variability (CV) problem caused by the accuspheres inside the… | Future Diagnostics Solutions B.V. | 12/06/2022Open, Classified |
| Z-0878-2023 Class II | VITROS Immunodiagnostic Products Intact PTH Reagent Pack- IVD For the quantitative…Lower than expected iPTH patient and Quality Control (QC) results, reported negatively biased iPTH results-… | Ortho-Clinical Diagnostics, Inc. | 11/17/2022Open, Classified |
| Z-1342-2021 Class II | LIAISON 1-84 PTH Assay - Product Usage: is an in vitro chemiluminescent immunoassay…Potential for system to produce falsely elevated parathyroid hormone (PTH) results from patient samples. | Diasorin Inc. | 11/23/2020Terminated |
| Z-0979-2017 Class II | SIEMENS IMMULITE 2000/2000 Xpi Systems Intact PTH (Parathyroid Hormone) Test Code iPTH…Siemens is conducting this recall for the IMMULITE 2000/IMMULITE 2000 XPi Intact PTH (Intact Parathyroid… | Siemens Healthcare Diagnostics, Inc. | 11/22/2016Terminated |
| Z-1520-2018 Class III | Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the quantification…There may be a loss of separation between Calibrators A and B which may impact the assay calibration at the… | Diagnostic Hybrids, Inc. | 10/26/2016Terminated |
| Z-0903-2017 Class II | VITROS Immunodiagnostic Products Intact PTH Reagent Pack: 1) UPN 10758750006287 /…The device defect is a positive bias of up to 20% relative to the currently marketed Roche device. In… | Ortho-Clinical Diagnostics | 10/05/2016Terminated |
| Z-0173-2014 Class III | ADVIA Centaur Intact PTH Calibrator (6 pack); Catalog Number: SMN 10492387 For in vitro…PTH Calibrator packaged with only high calibrator. | Siemens Healthcare Diagnostics, Inc | 08/16/2013Terminated |
| Z-1513-2013 Class II | ADVIA Centaur iPTH ReadyPack Assay 500 Tests; REF 10492369, 10493615, 1049361. For in…iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability | Siemens Healthcare Diagnostics, Inc | 05/14/2013Terminated |
| Z-1512-2013 Class II | ADVIA Centaur iPTH ReadyPack Assay 100 Tests; REF 10492368. For in vitro diagnostic use…iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability | Siemens Healthcare Diagnostics, Inc | 05/14/2013Terminated |
| Z-0585-2011 | Active INTACT PTH, Part Number: DSL-8000 The DSL-80000 ACTIVE Intact PTH IRMA Kit…The recall was initiated because Beckman Coulter has confirmed that the stated stability of the DSL-10-8000… | Beckman Coulter Inc. | 04/22/2010Terminated |
| Z-0584-2011 | Active I-PTH ELISA, Part Number: DSL-10-8000 The DSL-10-80000 ACTIVE I-PTH Enzyme-Linked…The recall was initiated because Beckman Coulter has confirmed that the stated stability of the DSL-10-8000… | Beckman Coulter Inc. | 04/22/2010Terminated |
| Z-0107-2011 | Active I-PTH Enzyme-Linked Immunosorbent Assay(ELISA), Part Number: DSL-10-8000 The…The recall was initiated after Beckman Coulter confirmed that the stated stability of the DSL-10-8000 I-PTH… | Beckman Coulter Inc. | 03/04/2010Terminated |
| Z-1186-2012 | ADVIA Centaur Intact PTH (iPTH) Assay -assay (lot 138) Cat. Nos. 100 Test kit 04385983…Poor sensitivity and imprecision on ADVIA Centaur systems; Serum samples low bias; EDTA plasma samples low… | Siemens Healthcare Diagnostics, Inc | 10/03/2008Terminated |
| Z-0810-2007 | Roche PTH (parathyroid hormone test system) for use in conjunction with Roche cobas e…Negative bias caused by hemolysis interference at the low end of the reference range could cause erroneous… | Roche Diagnostics Corp. | 04/19/2007Terminated |