# Automated analysers for tumour-marker blood tests (Elecsys, Atellica, Access, VITROS, Lumipulse)

Source: https://onco.cc/technologies/tumour-marker-immunoassay-analysers/  
OnCo record `tumour-marker-immunoassay-analysers` (Technology). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Summary

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.

## Fields

- Kind: Technology
- Status: standard-of-care
- Last checked: 2026-11-04
- Also known as: Tumour marker analyser; Elecsys; cobas e; Atellica IM; ADVIA Centaur; Access; VITROS; Lumipulse
- Tags: devices-gaps-2026-11
- Principle: 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.
- Since: 2000
- Strengths: Fast, automated, high-throughput measurement; FDA-reviewed assays for monitoring
- Limitations: Each assay is cleared for its own platform; The serum tumour marker record explains where markers mislead

## Sources

- FDA PMA P990056: Elecsys total PSA (22 November 2000): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P990056
- FDA PMA P000027: Elecsys free PSA (12 December 2000): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P000027
- FDA PMA P240021: Atellica IM total PSA II (3 December 2025): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240021
- FDA 510(k) K200215: ADVIA Centaur CEA (13 April 2020): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K200215
- FDA 510(k) K223921: Access CEA (22 September 2023): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223921
- FDA 510(k) K231517: VITROS CEA (23 August 2023): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231517
- FDA 510(k) K171605: Elecsys CA 15-3 II (20 February 2018): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K171605
- FDA 510(k) K192524: Lumipulse G CA15-3 (4 September 2020): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K192524

## Connected records

- cancers: [Breast cancer (all types)](https://onco.cc/cancers/breast-cancer/), [Colorectal cancer](https://onco.cc/cancers/colorectal/), [Prostate cancer](https://onco.cc/cancers/prostate/)
- fronts: [Devices & Physical Therapies](https://onco.cc/fronts/devices/), [Diagnostics & Biomarkers](https://onco.cc/fronts/diagnostics/)
- technologies: [Haematology analysers and digital blood film and marrow morphology (Sysmex XN, DxH 900, CellaVision, Scopio)](https://onco.cc/technologies/haematology-analysers/), [M-protein analysers: mass spectrometry, capillary electrophoresis and free light chain assays (EXENT, Capillarys, Freelite)](https://onco.cc/technologies/m-protein-laboratory-analysers/), [Serum tumour markers: proper use and misuse](https://onco.cc/technologies/serum-tumour-markers/)
- companies: [Beckman Coulter](https://onco.cc/companies/beckman-coulter/), [Fujirebio](https://onco.cc/companies/fujirebio/), [Roche / Genentech](https://onco.cc/companies/roche-genentech/), [Siemens Healthineers](https://onco.cc/companies/siemens-healthineers/)
- terms: [PSA (prostate-specific antigen)](https://onco.cc/terms/psa/), [Tumour markers (CEA, LDH, chromogranin, thyroglobulin)](https://onco.cc/terms/tumour-markers/)

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