Product code QSE

Device name: Alzheimer’S Disease Pathology Assessment Test
Medical specialty: Immunology
Device class: 2
Regulation number: 866.5840
Review panel: IM
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Ineligible
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.
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K231348	Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF	Roche Diagnostics	2023-06-05
K221842	Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF	Roche Diagnostics	2022-12-07
DEN200072	Lumipulse G ß-Amyloid Ratio (1-42/1-40)	Fujirebio Diagnostics,Inc.	2022-05-04

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
07613336221761	Elecsys Total -Tau CSF	Roche Diagnostics GmbH	2023-08-23
07613336167649	Elecsys Total-Tau CSF	Roche Diagnostics GmbH	2023-08-11
07613336167663	Elecsys Phospho-Tau (181P) CSF	Roche Diagnostics GmbH	2022-12-17
07613336208366	Elecsys Phospho-Tau (181P) CSF	Roche Diagnostics GmbH	2022-12-17
07613336166321	Elecsys beta-Amyloid (1-42) CSF II	Roche Diagnostics GmbH	2022-12-17
07613336208359	Elecsys Beta-Amyloid (1-42) CSF II	Roche Diagnostics GmbH	2022-12-17

Related 510(k) Records#