510(k) · Cleared
Recalled · Class II · 2025Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujirebio Diagnostics,Inc. · SET Immunoassay Blood Test For Amyloid Pathology Assessment
Cleared on May 16, 2025 as substantially equivalent to DEN200072 (Fujirebio Diagnostics,Inc., 2022) after a 249-day review. Its family tree reaches back 1 generation to 2022. 1 later device descends from it. It has been recalled 7 times.
- Decided
- May 16, 2025
- Review
- 249 days
- Class
- Class II
- Product code
- SET
- Recalls
- 7
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN200072 (2022). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backDEN200072 Lumipulse G ß-Amyloid Ratio (1-42/1-40)Fujirebio Diagnostics,Inc. · 2022
- This deviceK242706 Lumipulse G pTau217/ß-Amyloid 1-42 Plasma RatioFujirebio Diagnostics,Inc. · 2025
- Descendant · cites it directly · 0 of its ownK261686 Elecsys Phospho-Tau (217P) PlasmaRoche Diagnostics · 2026
Most influential descendants
Showing 1 of 1 · See all- K261686Elecsys Phospho-Tau (217P) PlasmaRoche Diagnostics · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN200072 | Lumipulse G ß-Amyloid Ratio (1-42/1-40) | Fujirebio Diagnostics,Inc. | 2022 | — |
| 0 (this device) | K242706 | Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio | Fujirebio Diagnostics,Inc. | 2025 | — |
| +1 | K261686 | Elecsys Phospho-Tau (217P) Plasma | Roche Diagnostics | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 0 |
Sources: FDA 510(k) 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.
Planning a device in SET? 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 SET device
- #1 K261686 Elecsys Phospho-Tau (217P) Plasmascore 12.2 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN200072 | Lumipulse G ß-Amyloid Ratio (1-42/1-40)Summary page 11…CE INFORMATION: A. Predicate Device Name(s): Lumipulse G β-Amyloid Ratio (1-42/1-40) B. Predicate 510(k) Number(s): DEN200072 C. Comparison with Predicate(s): Similarities and Differences… | 2022 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K261686 | Elecsys Phospho-Tau (217P) Plasma | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 11, 2025 | Class II | Z-1301-2026 | Under Investigation by firm | Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely… |
| Dec 11, 2025 | Class II | Z-1304-2026 | Under Investigation by firm | Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely… |
| Dec 11, 2025 | Class II | Z-1302-2026 | Under Investigation by firm | Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely… |
| Dec 11, 2025 | Class II | Z-1306-2026 | Under Investigation by firm | Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely… |
| Dec 11, 2025 | Class II | Z-1303-2026 | Under Investigation by firm | Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely… |
| Dec 11, 2025 | Class II | Z-1305-2026 | Under Investigation by firm | Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely… |
| Dec 11, 2025 | Class II | Z-1307-2026 | Under Investigation by firm | Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely… |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All SET devicesSET Immunoassay Blood Test For Amyloid Pathology Assessment: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · SET
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · SET
Too few SET 510(k)s in any year since 2007 to give a median.
Recalls per year · SET
No recall names SET since 2007.
Adverse event reports per year · SET
No MAUDE report names SET 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 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Lumipulse G pTau 217/P-Amyloid 1-42 Plasma Ratio is an in vitro test using human plasma (K2EDTA) that combines the results of Lumipulse G pTau 217 Plasma and Lumipulse G P-Amyloid 1-42-N Plasma assays into a ratio of pTau 217 to P-Amyloid 1-42 concentrations using the Lumipulse Gl 200 System. The Lumipulse G pTau 217/P-Amyloid 1-42 Plasma Ratio is intended to aid healthcare providers to identify patients with amyloid pathology associated with…
Read the full statement (232 words)
The Lumipulse G pTau 217/P-Amyloid 1-42 Plasma Ratio is an in vitro test using human plasma (K2EDTA)
that combines the results of Lumipulse G pTau 217 Plasma and Lumipulse G P-Amyloid 1-42-N Plasma
assays into a ratio of pTau 217 to P-Amyloid 1-42 concentrations using the Lumipulse Gl 200 System.
The Lumipulse G pTau 217/P-Amyloid 1-42 Plasma Ratio is intended to aid healthcare providers to
identify patients with amyloid pathology associated with Alzheimer's disease.
The Lumipulse G pTau 217/P-Amyloid 1-42 Plasma Ratio is indicated for adult patients, aged 50 years and
older, presenting at a specialized care setting with signs and symptoms of cognitive decline.
A test results; 0.00370 is a negative result which is consistent with patients who are unlikely to have
amyloid pathology. These patients should be investigated for other causes of cognitive decline.
A test result� 0.00738 is a positive result which is consistent with patients who are likely to have amyloid
pathology. This result does not establish a diagnosis of Alzheimer's disease or other cognitive disorders.
A test result between 0.00371 and 0.00737 is an indeterminate result which is consistent with patients
who are uncertain to have amyloid pathology. These patients should be considered for further testing.
The Lumipulse G pTau 217/P-Amyloid 1-42 Plasma Ratio 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K242706 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242706: Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242706
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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