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FDA Classifies Alzheimer's Pathology Test as Class II

FDA finalized classification of the Alzheimer's disease pathology assessment test as Class II (special controls), codifying the device type under 21 CFR 866.5840. The classification was applicable May 4, 2022, following De Novo review of Fujirebio Diagnostics' Lumipulse G β-Amyloid Ratio (1-42/1-40) device. Special controls identified in the order will apply to all devices of this generic type.