# M-protein analysers: mass spectrometry, capillary electrophoresis and free light chain assays (EXENT, Capillarys, Freelite)

Source: https://onco.cc/technologies/m-protein-laboratory-analysers/  
OnCo record `m-protein-laboratory-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 find and measure the abnormal antibody (M-protein) made by myeloma cells in a blood sample, used to diagnose myeloma and related conditions and to follow treatment.

## Summary

The Binding Site's EXENT analyser with its immunoglobulin isotypes (GAM) assay was cleared on 17 October 2025 (K250159) under a new mass spectrometric immunoglobulin code (SGG); the assay is "an aid in the evaluation of monoclonal gammopathy of undetermined significance (MGUS); and as an aid in the diagnosis of smouldering multiple myeloma (SMM), multiple myeloma (MM), Waldenström's macroglobulinaemia, and AL amyloidosis". Sebia's Capillarys 3 Tera with CAPI 3 immunotyping (K192095, 1 November 2019, code CFF) performs capillary electrophoresis. The Binding Site's free light chain assays on its Optilite analyser include Freelite kappa and lambda (K231290, 24 January 2024), Freelite Mx (K250549, 23 May 2025) and the Hevylite IgG kappa and lambda heavy and light chain kits (K172613, 15 February 2018). The glossary entry on M-protein and free light chains explains the tests.

## Fields

- Kind: Technology
- Status: established
- Last checked: 2026-11-04
- Also known as: EXENT; MALDI-TOF M-protein; Mass spectrometry for M-protein; Capillarys; Capillary electrophoresis; Immunotyping; Freelite; Hevylite; Optilite
- Tags: devices-gaps-2026-11
- Principle: Immunoglobulins are enriched with antibody-coated beads and their light chains measured by mass (matrix-assisted laser desorption ionisation time of flight), separated by charge in a capillary, or quantified by nephelometric immunoassay for free light chains.
- Since: 2018
- Strengths: Mass spectrometry detects small M-proteins below electrophoresis limits; Automated platforms in routine laboratories
- Limitations: Mass spectrometry is newly cleared and not yet standard everywhere; Free light chain results vary with kidney function and between methods

## Sources

- FDA 510(k) K250159: EXENT analyser and immunoglobulin isotypes (GAM) (17 October 2025): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250159
- FDA 510(k) K192095: Sebia Capillarys 3 Tera and CAPI 3 immunotyping (1 November 2019): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K192095
- FDA 510(k) K231290: Optilite Freelite kappa and lambda (24 January 2024): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231290
- FDA 510(k) K250549: Optilite Freelite Mx (23 May 2025): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250549
- FDA 510(k) K172613: Optilite Hevylite IgG kappa and lambda (15 February 2018): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K172613

## Connected records

- cancers: [Multiple myeloma](https://onco.cc/cancers/multiple-myeloma/), [Waldenström macroglobulinaemia](https://onco.cc/cancers/waldenstrom/)
- fronts: [Devices & Physical Therapies](https://onco.cc/fronts/devices/), [Diagnostics & Biomarkers](https://onco.cc/fronts/diagnostics/)
- technologies: [Automated analysers for tumour-marker blood tests (Elecsys, Atellica, Access, VITROS, Lumipulse)](https://onco.cc/technologies/tumour-marker-immunoassay-analysers/), [Haematology analysers and digital blood film and marrow morphology (Sysmex XN, DxH 900, CellaVision, Scopio)](https://onco.cc/technologies/haematology-analysers/), [Powered bone marrow biopsy drivers (OnControl, BD Trek, OmniBone)](https://onco.cc/technologies/bone-marrow-biopsy-devices/)
- terms: [M-protein, immunofixation and serum free light chains](https://onco.cc/terms/m-protein-free-light-chains/), [Smouldering myeloma / MGUS](https://onco.cc/terms/smoldering-myeloma/)

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