← Back to catalogue

Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF

FDA 510(k)

Class II (US FDA 510(k))

510(k) K221842

by Roche Diagnostics

Identifiers

510(k) Number
K221842 FDA 510(k)
FDA Product Code
QSE FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.5840 FDA 510(k)
Regulation Number
866.5840 FDA 510(k)
Advisory Committee
Immunology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Elecsys B-Amyloid (1-42) CSF II and Elecsys Phospho-Tau (181P) CSF are in vitro electrochemiluminescence immunoassays designed for the measurement of protein concentrations in cerebrospinal fluid. These tests are intended for use in adult patients aged 55 years and older who are being evaluated for Alzheimer's disease and other causes of cognitive impairment. The assays may be used alone or in combination as a ratio to aid in identifying subjects with mild cognitive impairment who are at a lower or higher risk of cognitive decline.

This device is authorized via FDA 510(k) clearance. It is classified as an Alzheimer's disease pathology assessment test under regulation number 866.5840. The product is manufactured by Roche Diagnostics and is intended for clinical laboratory use.

Frequently asked questions

What is the intended use of the Elecsys B-Amyloid and Phospho-Tau CSF assays?

These assays are designed for the in vitro measurement of protein concentrations in cerebrospinal fluid. They are intended for use in adult patients aged 55 and older who are undergoing evaluation for Alzheimer's disease or other causes of cognitive impairment to help assess the risk of cognitive decline.

How are these assays utilized in a clinical setting?

The tests are intended for clinical laboratory use. They may be used individually or in combination as a ratio to assist clinicians in identifying patients with mild cognitive impairment who are at a higher or lower risk of experiencing cognitive decline.

What is the regulatory status of these Roche Diagnostics assays?

The Elecsys B-Amyloid (1-42) CSF II and Elecsys Phospho-Tau (181P) CSF are authorized via FDA 510(k) clearance. They are classified as Alzheimer's disease pathology assessment tests under regulation number 866.5840.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Elecsys® β-Amyloid (1-42) CSF II - Roche Diagnostics USA, Elecsys® β-Amyloid (1-42) CSF II - Roche Diagnostics USA, Elecsys β-Amyloid (1-42) CSF II - elabdoc-prod.roche.com

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Roche Diagnostics

Sources (1)

  • FDA 510(k) K221842 24 fields · synced Sep 21, 2026