Radioimmunoassay, Acth
FDA product code CKG · Class II (moderate risk) · 21 CFR 862.1025 · Clinical Chemistry
30510(k) clearances
0PMA approvals
5recalls
Manufacturers
- Diagnostic Systems Laboratories, Inc. 3
- Nichols Institute Diagnostics 3
- Scantibodies Laboratory, Inc. 2
- Syncor Intl. Corp. 2
- Diagnostic Products Corp. 2
- Immuno Nuclear Corp. 2
- Compagnie Oris Industrie, S.A. 1
- Immunodiagnostic Systems , Ltd. 1
- Roche Diagnostics Corp. 1
- Future Diagnostics B.V. 1
- Sangui Biotech, Inc. 1
- Hawksley & Sons , Ltd. 1
- Incstar Corp. 1
- Nichols Institute 1
- Mitsubishi Yuka America, Inc. 1
- Science Regulatory Services Intl. 1
- Euro-Diagnostics BV 1
- Clinetics Corp. 1
- Radioassay Systems Laboratories, Inc. 1
- Damon Corp. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K223867 | Ids Acth IICKG · Traditional | Immunodiagnostic Systems Limited | 08/18/2023SE |
| K111335 | ST Aia-Pack Acth, and ST Aia-Pack Acth Calibrator Set Model 025221 and 025321CKG · Traditional | Tosoh Bioscience, Inc. | 12/01/2011SE |
| K060585 | Roche Elecsys- Acth,Acth Calset,Acth Calcheck,Precicontrol ActhCKG · Traditional | Roche Diagnostics Corp. | 05/03/2006SE |
| K050748 | Acth Immunoradiometric (Irma) Assay Kit, Model 3KG011CKG · Traditional | Scantibodies Laboratory, Inc. | 05/20/2005SE |
| K021032 | Acth Immunoradiometric (Irma) Diagnostic Assay Kit, Model #3KG100CKG · Traditional | Scantibodies Laboratory, Inc. | 06/03/2002SE |
| K002638 | Future Diagnostics B.V. Stat-Acth KitCKG · Traditional | Future Diagnostics B.V. | 01/17/2001SE |
| K982608 | Sangui Biotech, Inc. Acth (Adrenocorticotropic Hormone) Elisa KitCKG · Traditional | Sangui Biotech, Inc. | 08/19/1998SE |
| K962601 | Nichols Advantage Chemiluminescence Adrenocorticotropic HormoneCKG · Traditional | Nichols Institute Diagnostics | 12/24/1996SE |
| K960491 | Micro Haematocrit CentrifugeCKG · Traditional | Hawksley & Sons , Ltd. | 10/18/1996SE |
| K960066 | Immulite ActhCKG · Traditional | Diagnostic Products Corp. | 02/16/1996SE |
| K940271 | Incstar Acth IrmaCKG · Traditional | Incstar Corp. | 08/02/1994SE |
| K926396 | Adrenocorticotropic/Acth Analysis ProductCKG · Traditional | Nichols Institute | 07/27/1993SE |
| K915727 | Acth Irma Kit II Mitsubishi YukaCKG · Traditional | Mitsubishi Yuka America, Inc. | 03/02/1992SE |
| K910178 | Acth Irma Kit Mitsubishi YukaCKG · Traditional | Science Regulatory Services Intl. | 05/22/1991SE |
| K900147 | Modified DSL-2300 Acth RiaCKG · Traditional | Diagnostic Systems Laboratories, Inc. | 03/01/1990SE |
| K882741 | Allegro Acth Immunoassay Kit 65 and 130 TubesCKG · Traditional | Nichols Institute Diagnostics | 08/30/1988SE |
| K860311 | Acthk-Pr Ria KitCKG · Traditional | Compagnie Oris Industrie, S.A. | 04/07/1986SE |
| K850053 | Baci 6 -Adrenocorticotroop HormoneCKG · Traditional | Euro-Diagnostics BV | 04/08/1985SE |
| K850882 | Acth II by RadioimmunoassayCKG · Traditional | Immuno Nuclear Corp. | 03/21/1985SE |
| K844181 | Acth RiaCKG · Traditional | Syncor Intl. Corp. | 11/27/1984SE |
| K842249 | Acth Normal RangeCKG · Traditional | Diagnostic Systems Laboratories, Inc. | 08/15/1984SE |
| K833934 | Adrenocorticotropic Hormone TestCKG · Traditional | Clinetics Corp. | 04/04/1984SE |
| K840018 | DPC Acth KitCKG · Traditional | Diagnostic Products Corp. | 03/23/1984SE |
| K833849 | Acth RiaCKG · Traditional | Syncor Intl. Corp. | 01/30/1984SE |
| K833471 | Adrenocor Ticotropic Hormone RadioimmCKG · Traditional | Nichols Institute Diagnostics | 01/11/1984SE |
| K831855 | Hatch KitCKG · Traditional | Radioassay Systems Laboratories, Inc. | 07/28/1983SE |
| K831826 | Adrenocorticotropin Radio-ImmunoassayCKG · Traditional | Damon Corp. | 07/18/1983SE |
| K830893 | Acth Ria System-Dsi 2300CKG · Traditional | Diagnostic Systems Laboratories, Inc. | 04/27/1983SE |
| K822115 | Seragan ACTH125 I-Ria KitCKG · Traditional | Seragen Diagnostics, Inc. | 10/18/1982SE |
| K811565 | Acth Radioimmunoassay KitCKG · Traditional | Immuno Nuclear Corp. | 06/25/1981SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0791-2026 Class II | Neurotransmitters XLDistribution without premarket approval/clearance. | Get Tested International AB | 11/03/2025Open, Classified |
| Z-0790-2026 Class II | Neurotransmitters PlusDistribution without premarket approval/clearance. | Get Tested International AB | 11/03/2025Open, Classified |
| Z-0789-2026 Class II | Neurotransmitters BasicDistribution without premarket approval/clearance. | Get Tested International AB | 11/03/2025Open, Classified |
| Z-0676-2019 Class II | ST AIA-PACK ACTH (ACTH: Adrenocorticotropic Hormone) is designed for IN VITRO DIAGNOSTIC… | Tosoh Bioscience Inc | 11/30/2018Terminated |
| Z-2225-2012 Class II | UniCel DxH Slidemaker Stainer Instrument System, PN 775222. The DxH Slidemaker Stainer…The recall was initiated because Beckman Coulter has confirmed that the DxH Slidemaker Stainer Floor Stand… | Beckman Coulter Inc. | 12/13/2011Terminated |