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The laboratory machines that measure tumour markers such as PSA, CEA and CA 15-3 in a blood sample. Each test is cleared by the FDA for a named analyser.
Tumour-marker assays are cleared per assay and platform. PSA tests for detection need PMA (product code MTF): Roche's Elecsys total PSA (P990056, 22 November 2000) and free PSA (P000027, 12 December 2000), and Siemens' Atellica IM total PSA II (P240021, 3 December 2025, with a monitoring 510(k), K251630). CEA assays are code DHX: Siemens ADVIA Centaur CEA (K200215, 13 April 2020), Beckman Coulter Access CEA (K223921, 22 September 2023) and Ortho's VITROS CEA (K231517, 23 August 2023). Other tumour antigen tests are code MOI, for example Roche's Elecsys CA 15-3 II (K171605, 20 February 2018) and Fujirebio's Lumipulse G CA15-3 (K192524, 4 September 2020). The serum tumour marker record covers when the markers help and when they mislead.
Antibodies bound to magnetic microparticles capture the marker in serum; a second labelled antibody generates an electrochemiluminescent, chemiluminescent or enzymatic signal proportional to its concentration, read against a calibration curve.
Query for this technology: (TITLE:"Automated analysers for tumour-marker blood tests" OR ABSTRACT:"Automated analysers for tumour-marker blood tests" OR TITLE:"Elecsys, Atellica, Access, VITROS, Lumipulse" OR ABSTRACT:"Elecsys, Atellica, Access, VITROS, Lumipulse" OR TITLE:"Tumour marker analyser" OR ABSTRACT:"Tumour marker analyser" OR TITLE:"Elecsys" OR ABSTRACT:"Elecsys") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Automated analysers for tumour-marker blood tests (Elecsys, Atellica, Access, VITROS, Lumipulse), not a curated reading list.
Shares M-protein analysers: mass spectrometry, capillary electrophoresis and free light chain assays (EXENT, Capillarys, Freelite), Haematology analysers and digital blood film and marrow morphology (Sysmex XN, DxH 900, CellaVision, Scopio) and the tag devices-gaps-2026-11.
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Shares Breast cancer (all types), Colorectal cancer and the tag devices-gaps-2026-11.
Shares Breast cancer (all types) and the tag devices-gaps-2026-11.
Shares Breast cancer (all types) and the tag devices-gaps-2026-11.
Shares Breast cancer (all types) and the tag devices-gaps-2026-11.
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