Not Cleared Direct

DEN200072 - Lumipulse G ß-Amyloid Ratio (1-42/1-40) (FDA 510(k) Clearance)

Class II Immunology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN200072 · Fujirebio Diagnostics,Inc. · Immunology device
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May 2022
Decision
530d
Days
Class 2
Risk

DEN200072 is an FDA 510(k) submission (not cleared) for the Lumipulse G ß-Amyloid Ratio (1-42/1-40). Classified as Alzheimer’s Disease Pathology Assessment Test (product code QSE), Class II - Special Controls.

Submitted by Fujirebio Diagnostics,Inc. (Malvern, US). The FDA issued a Not Cleared (DENG) decision on May 4, 2022 after a review of 530 days.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5840 - the FDA immunology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 530 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Fujirebio Diagnostics,Inc. devices

Submission Details

510(k) Number DEN200072 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received November 20, 2020
Decision Date May 04, 2022
Days to Decision 530 days
Submission Type Direct
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
426d slower than avg
Panel avg: 104d · This submission: 530d
Pathway characteristics

Device Classification

Product Code QSE Alzheimer’s Disease Pathology Assessment Test
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.