De Novo · Granted
GrantedLumipulse G ß-Amyloid Ratio (1-42/1-40)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujirebio Diagnostics,Inc. · QSE Alzheimer’S Disease Pathology Assessment Test
Granted on May 4, 2022 as a new device type through De Novo after a 530-day review. 1 of the 11 devices in its family, counting itself, has a Class I recall. 10 later devices descend from it.
- Decided
- May 4, 2022
- Review
- 530 days
- Class
- Class II
- Product code
- QSE
- Recalls
- None
10 later devices descend from it, 4 citing it directly. 1 of the 11 devices in this family, counting this one, has a Class I recall.
- This deviceDEN200072 Lumipulse G ß-Amyloid Ratio (1-42/1-40)Fujirebio Diagnostics,Inc. · 2022
- Descendant · cites it directly · 3 of its ownK233472 CVAC Aspiration System + CVAC Image ProcessorCalyxo, Inc. · 2024 · Recalled (Class I)
- Descendant · cites it directly · 2 of its ownK221842 Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSFRoche Diagnostics · 2022
- Descendant · cites it directly · 1 of its ownK242706 Lumipulse G pTau217/ß-Amyloid 1-42 Plasma RatioFujirebio Diagnostics,Inc. · 2025 · Recalled
- Descendant · 2 generations on · 0 of its ownK261447 CVAC® Aspiration SystemCalyxo, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK253240 PrecivityAD2 TestC2N Diagnostics, LLC · 2026
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K233472 CVAC Aspiration System + CVAC Image Processorcites it directly · 2024
Most influential descendants
Showing 5 of 10 · See all- K233472CVAC Aspiration System + CVAC Image ProcessorCalyxo, Inc. · 2024 · cites it directly3descendants
- K221842Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSFRoche Diagnostics · 2022 · cites it directly2descendants
- K242706Lumipulse G pTau217/ß-Amyloid 1-42 Plasma RatioFujirebio Diagnostics,Inc. · 2025 · cites it directly1descendant
- K261447CVAC® Aspiration SystemCalyxo, Inc. · 2026 · 2 generations on0descendants
- K253240PrecivityAD2 TestC2N Diagnostics, LLC · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN200072 | Lumipulse G ß-Amyloid Ratio (1-42/1-40) | Fujirebio Diagnostics,Inc. | 2022 | — |
| +1 | K233472 | CVAC Aspiration System + CVAC Image Processor | Calyxo, Inc. | 2024 | Class I |
| +1 | K221842 | Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF | Roche Diagnostics | 2022 | — |
| +1 | K242706 | Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio | Fujirebio Diagnostics,Inc. | 2025 | 7 |
| +2 | K261447 | CVAC® Aspiration System | Calyxo, Inc. | 2026 | — |
| +1 | K253240 | PrecivityAD2 Test | C2N Diagnostics, LLC | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 1 |
| 2025 | 2 | 0 |
| 2026 | 5 | 0 |
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QSE device
- #1 K221842 Elecsys B-Amyloid (1-42) CSF II, Elecsys…score 10.5 · 1 generation · no Class I recall
- #2 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (10)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K233472CVAC Aspiration System + CVAC Image ProcessorCalyxo, Inc. · 2024 · Cites it directly · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K233472 (Calyxo, Inc., 2024) has gone furthest, with 3 descendants of its own.
How does its category compare?
All QSE devicesQSE Alzheimer’S Disease Pathology Assessment Test: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · QSE
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · QSE
Too few QSE 510(k)s in any year since 2007 to give a median.
Recalls per year · QSE
No recall names QSE since 2007.
Adverse event reports per year · QSE
No MAUDE report names QSE since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (233 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN200072 · printed Nov 3, 2026
Cite this page
510(k) Report. “DEN200072: Lumipulse G ß-Amyloid Ratio (1-42/1-40).” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/DEN200072
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026