Fujirebio Seeks 510(k) Clearance for Alzheimer’s Disease Test
Fujirebio Diagnostics has filed a 510(k) submission with the FDA for its Lumipulse G β-Amyloid Ratio in vitro diagnostic, a test that helps evaluate patients for Alzheimer’s disease.
The semiquantitative diagnostic is intended for use in adults aged 50 and up who show cognitive impairment and are being assessed for Alzheimer’s disease and other causes of cognitive decline.
The test is run on the company’s Lumipulse G1200 instrument and has already received CE mark certification. It received a Breakthrough Device designation from the FDA in February 2019.