CEW · Radioimmunoassay, Parathyroid Hormone
Clinical Chemistry · 21 CFR 862.1545 · Class 2
Overview
| Product Code | CEW |
|---|---|
| Device Name | Radioimmunoassay, Parathyroid Hormone |
| Regulation | 21 CFR 862.1545 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
A parathyroid hormone test system is a device intended to measure the levels of parathyroid hormone in serum and plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 86)
Showing 20 most recent of 86 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K231927 | Elecsys PTH , Elecsys PTH STAT | Roche Diagnostics | Mar 22, 2024 | SESE |
| K232791 | Access Intact PTH | Beckman Coulter, Inc. | Mar 1, 2024 | SESE |
| K221197 | VITROS Immunodiagnostic Products Intact PTH II Reagent Pack | Ortho Clinical Diagnostics | Sep 5, 2023 | SESE |
| K190702 | Lumipulse G whole PTH | Fujirebio Diagnostics,Inc. | Aug 30, 2019 | SESE |
| K163658 | ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay | Siemens Healthcare Diagnostics, Inc. | May 23, 2017 | SESE |
| K161158 | IDS-iSYS Intact PTHN | Immunodiagnostic Systems , Ltd. | Jan 31, 2017 | SESE |
| K150879 | LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration Verifiers | DiaSorin, Inc. | Jun 22, 2015 | SESE |
| K133601 | ADVIA CENTAUR INTACT PARATHYROID HORMONE (IPTH) ASSAY | Siemens Healthcare Diagnostics, Inc. | Feb 5, 2014 | SESE |
| K132515 | LIAISON N-TACT PTH GEN II, CONTROL SET, CALIBRATION VERIFIERS | DiaSorin, Inc. | Nov 8, 2013 | SESE |
| K121981 | ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAY | Siemens Healthcare Diagnostics | Mar 21, 2013 | SESE |
| K103325 | IDS-ISYS INTACT PTH | Immunodiagnostic Systems , Ltd. | Feb 3, 2012 | SESE |
| K101921 | VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH REAGENT PACK, VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH CALIBRATORS, VIT | Ortho-Clinical Diagnostics | Oct 22, 2010 | SESE |
| K070709 | ROCHE ELECSYS PTH TEST SYSTEM | Roche Diagnostics Corp. | Jul 13, 2007 | SESE |
| K063605 | ST AIA-PACK INTACT PTH ASSAY | Tosoh Bioscience, Inc. | Jun 21, 2007 | SESE |
| K063232 | ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM, HIGH), MODELS 8K25-20, 8K25-25, 8K25-01 | Biokit, S.A. | Jun 19, 2007 | SESE |
| K070391 | ELECSYS PTH TEST SYSTEM | Roche Diagnostics Corp. | Mar 20, 2007 | SESE |
| K061190 | ACCESS INTACT PTH AND CALIBRATORS, MODELS A 16972 AND A 16953 | Beckman Coulter, Inc. | Sep 15, 2006 | SESE |
| K060420 | MODIFICATION TO WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILLUMINOMETRIC (ICMA) ASSAY KIT, MODEL 3KG002 | Scantibodies Laboratory, Inc. | Mar 1, 2006 | SESE |
| K060348 | MODIFICATION TO: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT | Scantibodies Laboratory, Inc. | Feb 27, 2006 | SESE |
| K053533 | IMMULITE/IMMULITE 1000 TURBO INTACT PTH | Diagnostic Products Corporation | Feb 3, 2006 | SESE |
Top Applicants
- Nichols Institute Diagnostics — 13 clearances
- Scantibodies Laboratory, Inc. — 10 clearances
- Diagnostic Products Corp. — 9 clearances
- Diagnostic Systems Laboratories, Inc. — 6 clearances
- Immuno Nuclear Corp. — 4 clearances
