# DEN200072: Lumipulse G ß-Amyloid Ratio (1-42/1-40)

- Pathway: De Novo (Direct)
- Applicant: Fujirebio Diagnostics,Inc.
- Decided: May 4, 2022 after 530 days
- Product code: QSE (Alzheimer’S Disease Pathology Assessment Test)
- Device class: 2
- Regulation: 21 CFR 866.5840
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 4 cite it directly.
1 of 11 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K233472: CVAC Aspiration System + CVAC Image Processor (2024), 3 descendants of its own
- K221842: Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF (2022), 2 descendants of its own
- K242706: Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio (2025), 1 descendant of its own
- K261447: CVAC® Aspiration System (2026), 0 descendants of its own
- K253240: PrecivityAD2 Test (2026), 0 descendants of its own

## Indications for use
The Lumipulse G β-Amyloid Ratio (1-42/1-40) is an in vitro cerebral spinal fluid (CSF) test that combines the results of Lumipulse G β-Amyloid 1-42 and Lumipulse G β-Amyloid 1-40 assays into a ratio of β-amyloid 1-42 to β-amyloid 1-40 concentrations using the LUMIPULSE G1200 System. The Lumipulse G β-Amyloid Ratio (1-42/1-40) is intended to be used in adult patients, aged 55 years and older, presenting with cognitive impairment who are being evaluated for Alzheimer’s disease (AD) and other causes of cognitive decline. A test result ≥ 0.073 is a negative result which is consistent with a negative amyloid positron emission tomography (PET) scan result. A negative result reduces the likelihood that a patient’s cognitive impairment is due to AD. A test result ≤ 0.058 is a positive result which is consistent with a positive amyloid PET scan result. A positive result does not establish a diagnosis of AD or other cognitive disorder. A test result between 0.059 and 0.072 is considered as a likely positive result as it is more likely consistent with a positive amyloid PET scan result. A likely positive result does not establish a diagnosis of AD or other cognitive disorders and has increased uncertainty in regard to amyloid PET positivity. The Lumipulse G β-Amyloid Ratio (1-42/1-40) results must be interpreted in conjunction with other patient clinical information. This test is not intended as a screening or stand-alone diagnostic test.

Source page: https://510kreport.com/device/DEN200072
Methodology: https://510kreport.com/methodology