510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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SETClass II

Immunoassay Blood Test For Amyloid Pathology Assessment

21 CFR 866.5840 / Immunology
FDA source (opens on fda.gov)

SET is the FDA product code for Immunoassay Blood Test For Amyloid Pathology Assessment, a class II device type, regulated under 21 CFR 866.5840. FDA's definition for this code reads: "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...". As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and 7 recalls.

Classification record

Product code
SET
Device name
Immunoassay Blood Test For Amyloid Pathology Assessment
FDA definition
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.
Regulation
21 CFR 866.5840
Device class
Class II
Review panel
Immunology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
4
Ingested recalls
7

Clearances, product code SET

By decision year
4 clearances under product code SET with a decision year between 2025 and 2026, 2025 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code SET by decision year
YearClearances
20252
20262

Applicants with the most clearances

Product code SET
Applicants holding the most 510(k) clearances under product code SET
ApplicantClearances
C2N Diagnostics, LLC1
Fujirebio Diagnostics, Inc.1
Roche Diagnostics1
Roche Diagnostics GmbH1

Companies listing this code with FDA

Companies whose registered establishments list this code