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
Declining activity - 0 submissions in the last 2 years vs 2 in the prior period

FDA 510(k) Cleared Alzheimer’s Disease Pathology Assessment Test Devices (Product Code QSE)

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

About Product Code QSE - Regulatory Context

510(k) Submission Activity

3 total 510(k) submissions under product code QSE since 2022, with 2 receiving FDA clearance (average review time: 241 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.

QSE devices are reviewed by the Immunology panel. Browse all Immunology devices →