System, Test, Carcinoembryonic Antigen
FDA product code DHX · Class II (moderate risk) · 21 CFR 866.6010 · Immunology
28510(k) clearances
1PMA approvals
5recalls
Manufacturers
- Ortho-Clinical Diagnostics 3
- Beckman Coulter Inc. 3
- Tosoh Medics, Inc. 2
- Diagnostic Products Corp. 1
- Siemens Healthcare Disgnostics, Inc. 1
- Dade Behring, Inc. 1
- Bayer Corp. 1
- Beckman 1
- Abbott Laboratories 1
- Chiron Diagnostics Corp. 1
- Boehringer Mannheim Corp. 1
- Dpc Cirrus 1
- Environmental Chemical Specialties 1
- Ciba Corning Diagnostics Corp. 1
- Biosan Laboratories, Inc. 1
- Ventrex Laboratories, Inc. 1
- Pacific Hemostasis 1
- Bd Becton Dickinson Vacutainer Systems Preanalytic 1
- Immuno-Diagnostic Laboratories 1
- Amicon, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K223921 | Access CEADHX · Traditional | Beckman Coulter, Inc. | 09/22/2023SE |
| K231517 | VITROS Immunodiagnostic Products CEA Reagent PackDHX · Traditional | Ortho Clinical Diagnostics | 08/23/2023SE |
| K200215 | ADVIA Centaur CEA AssayDHX · Traditional | Siemens Healthcare Disgnostics, Inc. | 04/13/2020SE |
| K081615 | Olympus Cea - Carcinoembryonic AntigenDHX · Traditional | Olympus America, Inc. | 03/18/2009SE |
| K080194 | Vidas Cea (S) AssayDHX · Traditional | bioMerieux, Inc. | 10/09/2008SE |
| K071603 | Dimension Vista Carcinoembryonic Antigen Flex Reagent Cartridge (Cea)DHX · Traditional | Dade Behring, Inc. | 06/25/2008SE |
| K041322 | Vitros Immunodiagnostic Products Cea Reagent Pack/Calibrator/Range VerifiersDHX · Special | Ortho-Clinical Diagnostics, Inc. | 06/17/2004SE |
| K031270 | Access Cea Reagents for Use on the Access Immunoassay SystemsDHX · Special | Beckman Coulter, Inc. | 05/06/2003SE |
| K023893 | ST Aia-Pack Cea Enzyme ImmunoassayDHX · Special | Tosoh Medics, Inc. | 12/18/2002SE |
| K013568 | Cea Assay for the Advia Integrated Modular SystemDHX · Traditional | Bayer Corp. | 12/21/2001SE |
| K991707 | Modification to Access Cea Reagents for Use on the Access Immunoassay Analyzer, Models…DHX · Special | Beckman | 06/01/1999SE |
| K990943 | Vitros Immunodiagnostic Products Cea Calibrators, Vitros Immunodiagnostic Products Cea…DHX · Traditional | Ortho-Clinical Diagnostics, Inc. | 06/01/1999SE |
| K990774 | Abbott Architect CeaDHX · Traditional | Abbott Laboratories | 05/11/1999SE |
| K981985 | Access Cea Reagents on the Access Immunoassay Analyzer Model 33200, 33205, 33206 & 33209DHX · Traditional | Beckman Coulter, Inc. | 09/24/1998SE |
| K981478 | Acs:Centaur CeaDHX · Traditional | Chiron Diagnostics Corp. | 08/12/1998SE |
| K980887 | Elecsys Cea on the Elecsys 1010DHX · Traditional | Boehringer Mannheim Corp. | 06/29/1998SE |
| K980855 | Immulite 2000 Carcinoembryonic Antigen (Cea) KitDHX · Traditional | Dpc Cirrus | 04/21/1998SE |
| K970877 | Immulite CeaDHX · Traditional | Diagnostic Products Corp. | 09/22/1997SE |
| K924857 | Aia-Pack Cea Calibration Verification Test SetDHX · Traditional | Tosoh Medics, Inc. | 03/18/1993SE |
| K864877 | Tri-Level Ligand ControlDHX · Traditional | Ciba Corning Diagnostics Corp. | 05/21/1987SE |
| K833318 | Normal Goat SerumDHX · Traditional | Biosan Laboratories, Inc. | 01/03/1984SE |
| K820298 | Carcinoembryonic Antigen Control (4 LevDHX · Traditional | Ventrex Laboratories, Inc. | 04/08/1982SE |
| K812658 | Cea Control PlasmaDHX · Traditional | Pacific Hemostasis | 09/29/1981SE |
| K810459 | Three Level Control SeraDHX · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 08/03/1981SE |
| K811394 | Cea Desalting Dolumn Sephadex RDHX · Traditional | Immuno-Diagnostic Laboratories | 06/12/1981SE |
| K810810 | Amicon Ultrafiltration Membranes CmiiDHX · Traditional | Amicon, Inc. | 04/17/1981SE |
| K801306 | Clinetics Pca ColumnDHX · Traditional | Clinetics Corp. | 09/26/1980SE |
| K792377 | Carcinoembryonic Antigen (Cea) ControlDHX · Traditional | Environmental Chemical Specialties | 09/26/1980SE |
PMA approvals
- P840027 Cea-Roche(R) Eia · Roche Diagnostics GmbH · 05/13/1985
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2066-2018 Class II | ST-AIA PACK CEA; Part Number: 025254 Assay, Tumor MarkerAsfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or… | Tosoh Bioscience Inc | 03/05/2018Terminated |
| Z-1679-2018 Class II | IMMULITE 2000/IMMULITE 2000 XPi CEAConcentrations for the level of biotin that does not interfere is not currently listed in the instruction… | Siemens Healthcare Diagnostics, Inc. | 01/02/2018Terminated |
| Z-1678-2018 Class II | IMMULITE /IMMULITE 1000 CEAConcentrations for the level of biotin that does not interfere is not currently listed in the instruction… | Siemens Healthcare Diagnostics, Inc. | 01/02/2018Terminated |
| Z-0239-2016 Class II | Access CEA Assay, Part No. 33200. For the quantitative determination of Carcinoembryonic…Beckman Coulter is recalling the Access CEA reagent packs because they were filled incorrectly. | Beckman Coulter Inc. | 10/13/2015Terminated |
| Z-1627-2011 | CEA ELISA Kit. BioCheck, Foster City, CA 9440. Quantitative determination of AFP…Product labels indicate that the products are for IVD use and they do not have an approved 510(k). | BioCheck Inc | 12/22/2010Terminated |