FDA Product Code SET: Immunoassay Blood Test For Amyloid Pathology Assessment
An Immunoassay Blood Test For Amyloid Pathology Assessment Is An In Vitro Diagnostic Test Used To Identify Patients With Amyloid Pathology Associated With Alzheimers Disease Who Have Signs And Symptoms Of Cognitive Decline. The Results Of The Test Are To Be Interpreted In Conjunction With Other Patient Clinical Information.
Leading manufacturers include Fujirebio Diagnostics,Inc. and Roche Diagnostics.
2
Total
2
Cleared
170d
Avg days
2025
Since
Growing category -
2 submissions in the last 2 years
vs 0 in the prior period
FDA 510(k) Cleared Immunoassay Blood Test For Amyloid Pathology Assessment Devices (Product Code SET)
2 devices
Cleared
Oct 08, 2025
Elecsys Phospho-Tau (181P) Plasma
Roche Diagnostics
Immunology
90d
Cleared
May 16, 2025
Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio
Fujirebio Diagnostics,Inc.
Immunology
249d
About Product Code SET - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code SET since 2025, with 2 receiving FDA clearance (average review time: 170 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.