Product code CEW
- Device name
- Radioimmunoassay, Parathyroid Hormone
- Medical specialty
- Clinical Chemistry
- Device class
- 2
- Regulation number
- 862.1545
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K231927 | Elecsys PTH , Elecsys PTH STAT | Roche Diagnostics | 2024-03-22 |
| K232791 | Access Intact PTH | Beckman Coulter, Inc. | 2024-03-01 |
| K221197 | VITROS Immunodiagnostic Products Intact PTH II Reagent Pack | Ortho Clinical Diagnostics | 2023-09-05 |
| K190702 | Lumipulse G whole PTH | Fujirebio Diagnostics,Inc. | 2019-08-30 |
| K163658 | ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay | Siemens Healthcare Diagnostics, Inc. | 2017-05-23 |
| K161158 | IDS-iSYS Intact PTHN | Immunodiagnostic Systems , Ltd. | 2017-01-31 |
| K150879 | LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration Verifiers | DiaSorin, Inc. | 2015-06-22 |
| K133601 | ADVIA CENTAUR INTACT PARATHYROID HORMONE (IPTH) ASSAY | Siemens Healthcare Diagnostics, Inc. | 2014-02-05 |
| K132515 | LIAISON N-TACT PTH GEN II, CONTROL SET, CALIBRATION VERIFIERS | DiaSorin, Inc. | 2013-11-08 |
| K121981 | ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAY | Siemens Healthcare Diagnostics | 2013-03-21 |
| K103325 | IDS-ISYS INTACT PTH | Immunodiagnostic Systems , Ltd. | 2012-02-03 |
| K101921 | VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH REAGENT PACK, VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH CALIBRATORS, VIT | Ortho-Clinical Diagnostics | 2010-10-22 |
| K070709 | ROCHE ELECSYS PTH TEST SYSTEM | Roche Diagnostics Corp. | 2007-07-13 |
| K063605 | ST AIA-PACK INTACT PTH ASSAY | Tosoh Bioscience, Inc. | 2007-06-21 |
| K063232 | ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM, HIGH), MODELS 8K25-20, 8K25-25, 8K25-01 | Biokit, S.A. | 2007-06-19 |
| K070391 | ELECSYS PTH TEST SYSTEM | Roche Diagnostics Corp. | 2007-03-20 |
| K061190 | ACCESS INTACT PTH AND CALIBRATORS, MODELS A 16972 AND A 16953 | Beckman Coulter, Inc. | 2006-09-15 |
| K060420 | MODIFICATION TO WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILLUMINOMETRIC (ICMA) ASSAY KIT, MODEL 3KG002 | Scantibodies Laboratory, Inc. | 2006-03-01 |
| K060348 | MODIFICATION TO: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT | Scantibodies Laboratory, Inc. | 2006-02-27 |
| K053533 | IMMULITE/IMMULITE 1000 TURBO INTACT PTH | Diagnostic Products Corporation | 2006-02-03 |
| K051888 | TOTAL INTACT PTH IMMUNORADIOMETRIC ASSAY (COATED TUBE VERSION), MODEL 3KG013 | Scantibodies Laboratory, Inc. | 2005-10-18 |
| K051810 | WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC ASSAY (IRMA) COATED TUBE KIT, MODEL 3KG014 | Scantibodies Laboratory, Inc. | 2005-09-09 |
| K051141 | WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILUMINOMETRIC ASSAY (ICMA), MODEL 3KG002 | Scantibodies Laboratory, Inc. | 2005-07-26 |
| K051150 | TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT | Scantibodies Laboratory, Inc. | 2005-07-26 |
| K040813 | NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE, MODEL 62-7022 | Nichols Institute Diagnostics | 2004-06-08 |
| K033727 | NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAY | Nichols Institute Diagnostics | 2004-04-22 |
| K033426 | LIAISON N-TACT PTH | DiaSorin, Inc. | 2004-02-12 |
| K033302 | NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040 | Nichols Institute Diagnostics | 2004-01-26 |
| K031534 | CYCLASE ACTIVATING PTH (CAP) IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG001 | Scantibodies Laboratory, Inc. | 2003-07-30 |
| K022472 | PARATHYROID HORMONE TEST SYSTEM/NICHOLS ADVANTAGE QUICK-INTRAOPERATIVE BIO-INTACT PTH (1-84) | Nichols Institute Diagnostics | 2002-10-09 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00816870020402 | PTH Intact AccuBind ELISA Test System - 96 Wells | MONOBIND, INC. | 2024-09-13 |
| 00816870023731 | PTH Whole & Intact AccuLite VAST CLIA Test System - 192 Wells | MONOBIND, INC. | 2024-09-13 |
| 00816870023748 | PTH Whole & Intact AccuLite VAST CLIA Test System - 96 Wells | MONOBIND, INC. | 2024-09-13 |
| 00816870023755 | PTH Whole & Intact AccuBind VAST ELISA Test System - 192 Wells | MONOBIND, INC. | 2024-09-13 |
| 00816870023762 | PTH Whole & Intact AccuBind VAST ELISA Test System - 96 Wells | MONOBIND, INC. | 2024-09-13 |
| 00816870024516 | PTH Intact AccuBind ELISA Test System - 192 Wells | MONOBIND, INC. | 2024-09-13 |
| 00816870024523 | PTH Intact AccuLite CLIA Test System - 192 Wells | MONOBIND, INC. | 2024-09-13 |
| 07613336224939 | Elecsys PTH STAT | Roche Diagnostics GmbH | 2024-07-30 |
| 07613336224922 | Elecsys PTH | Roche Diagnostics GmbH | 2024-07-30 |
| 07613336170304 | Elecsys PTH | Roche Diagnostics GmbH | 2024-07-30 |
| 07613336217542 | Elecsys PTH | Roche Diagnostics GmbH | 2024-07-30 |
| 10758750032709 | VITROS | ORTHO CLINICAL DIAGNOSTICS | 2024-01-20 |
| 20758750032706 | VITROS | ORTHO CLINICAL DIAGNOSTICS | 2024-01-20 |
| 04048474036459 | PTH (Parathyroid) Intact ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2023-08-31 |
| 00630414954035 | IMMULITE® 2000 Systems INS Insulin Sample Diluent | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2020-09-24 |
| 00083059070224 | Intact-PTH [Parathyroid Hormone] ELISA [Enzyme-Linked ImmunoSorbent Assay] | BIOMERICA, INC. | 2020-07-01 |
| 00630414293745 | Atellica IM PTH | Siemens Healthcare Diagnostics Inc. | 2020-05-31 |
| 00380740156244 | ARCHITECT | Abbott GmbH | 2020-03-03 |
| 00850002253122 | Scantibodies Laboratory, Inc. | SCANTIBODIES LABORATORY, INC. | 2019-05-20 |
| 00850002253115 | Scantibodies Laboratory, Inc. | SCANTIBODIES LABORATORY, INC. | 2019-05-20 |
| 00840239036452 | PTH (Parathyroid) Intact ELISA | DRG International Inc | 2019-03-20 |
| 04015630939787 | Elecsys PTH | Roche Diagnostics GmbH | 2017-04-21 |
| 08719326045214 | Future Diagnostics | Future Diagnostics Solutions B.V. | 2016-12-21 |
| 08305900070224 | Intact-PTH [Parathyroid Hormone] ELISA [Enzyme-Linked ImmunoSorbent Assay] | BIOMERICA, INC. | 2016-12-07 |
| 00630414953236 | IMMULITE® Systems PTH CONTROL Intact PTH | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2016-09-24 |
| 04015630939237 | Elecsys PTH Immunoassay | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630939244 | Elecsys PTH STAT Immunoassay | Roche Diagnostics GmbH | 2016-09-20 |
| 00380740112776 | ARCHITECT | Abbott GmbH | 2016-09-09 |
| 00380740112769 | ARCHITECT | Abbott GmbH | 2016-09-09 |
| 10758750006267 | VITROS | ORTHO CLINICAL DIAGNOSTICS | 2016-08-26 |