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FDA PRODUCT CODE · CLASS II

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 Alzheimer’s 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.

DEVICE CLASS
Class II
REGULATION
21 CFR 866.5840
MEDICAL SPECIALTY
Immunology
REVIEW PANEL
IM
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
2
510(K)/PMA CLEARANCES
510k: 2
0
RECALL ENTRIES

Recent clearances

K252163Roche Diagnostics · 510k2025-10-08
K242706Fujirebio Diagnostics,Inc. · 510k2025-05-16

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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