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# Fujirebio Diagnostics 510(k) for Alzheimer’s Diagnostic
- URL: https://www.fdaweb.com/fujirebio-diagnostics-510-k-for-alzheimers-diagnostic/
- Published: 2020-12-02T12:00:00.000Z
- Updated: 2026-09-14T16:38:41.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5148207

Fujirebio Diagnostics has submitted a 510(k) for the Lumipulse G β-Amyloid Ratio (1-42/1-40) *in vitro* diagnostic test for use in assessing Alzheimer’s disease. The test uses Fujirebio’s automated Lumipulse G1200 instrument system to analyze results. According to Fujirebio, the device combines the concentrations of Lumipulse G β-Amyloid 1-42 and Lumipulse G β-Amyloid 1-40 found in human cerebral spinal fluid into a numerical ratio of β-Amyloid1-42/β-Amyloid1-40\. It is said to have been designed to help physicians triage their patients much sooner when effective interventions are more feasible using β-amyloid biomarkers.