QSE · Class II · 21 CFR 866.5840

FDA Product Code QSE: Alzheimer’s Disease Pathology Assessment Test

Blood-based biomarkers are transforming the early detection of Alzheimer's disease. FDA product code QSE covers in vitro tests for the assessment of Alzheimer's disease pathology.

These immunoassays detect amyloid beta, phosphorylated tau, or other Alzheimer's-associated biomarkers in cerebrospinal fluid or plasma, providing objective evidence of amyloid plaque pathology to aid in the diagnosis and patient selection for disease-modifying therapies.

QSE devices are Class II medical devices, regulated under 21 CFR 866.5840 and reviewed by the FDA Immunology panel.

Leading manufacturers include Roche Diagnostics and Fujirebio Diagnostics,Inc..

3
Total
2
Cleared
241d
Avg days
2022
Since

List of Alzheimer’s Disease Pathology Assessment Test devices cleared through 510(k)

3 devices
1–3 of 3
Cleared Jun 05, 2023
Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF
K231348
Roche Diagnostics
Immunology · 27d
Cleared Dec 07, 2022
Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF
K221842
Roche Diagnostics
Immunology · 166d
Not Cleared May 04, 2022
Lumipulse G ß-Amyloid Ratio (1-42/1-40)
DEN200072
Fujirebio Diagnostics,Inc.
Immunology · 530d

How to use this database

This page lists all FDA 510(k) submissions for Alzheimer’s Disease Pathology Assessment Test devices (product code QSE). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Immunology FDA review panel. Browse all Immunology devices →