Cleared Traditional

Elecsys ?-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF

K231348 · Roche Diagnostics · Immunology
Jun 2023
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K231348 is an FDA 510(k) clearance for the Elecsys ?-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF, a Alzheimer?s Disease Pathology Assessment Test (Class II — Special Controls, product code QSE), submitted by Roche Diagnostics (Indianapolos, US). The FDA issued a Cleared decision on June 5, 2023, 27 days after receiving the submission on May 9, 2023. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5840.

Submission Details

510(k) Number K231348 FDA.gov
FDA Decision Cleared SESE
Date Received May 09, 2023
Decision Date June 05, 2023
Days to Decision 27 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code QSE — Alzheimer?s Disease Pathology Assessment Test
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5840
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.