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

Alzheimer’S Disease Pathology Assessment Test

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

QSE is the FDA product code for Alzheimer’S Disease Pathology Assessment Test, a class II device type, regulated under 21 CFR 866.5840. FDA's definition for this code reads: "In vitro test to determine whether a patient presenting with cognitive impairment and being evaluated for AD and other causes of cognitive decline will test positive or negative for amyloid plaques or neurofibrillary tangles as measured by PET imaging agents". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QSE
Device name
Alzheimer’S Disease Pathology Assessment Test
FDA definition
In vitro test to determine whether a patient presenting with cognitive impairment and being evaluated for AD and other causes of cognitive decline will test positive or negative for amyloid plaques or neurofibrillary tangles as measured by PET imaging agents.
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
3
Ingested recalls
0

Clearances, product code QSE

By decision year
3 clearances under product code QSE with a decision year between 2022 and 2023, 2022 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code QSE by decision year
YearClearances
20222
20231

Applicants with the most clearances

Product code QSE
Applicants holding the most 510(k) clearances under product code QSE
ApplicantClearances
Roche Diagnostics GmbH2
Fujirebio Diagnostics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code