# K242706: Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio

- Pathway: 510(k) (Traditional)
- Applicant: Fujirebio Diagnostics,Inc.
- Decided: May 16, 2025 after 249 days
- Product code: SET (Immunoassay Blood Test For Amyloid Pathology Assessment)
- Device class: 2
- Regulation: 21 CFR 866.5840
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN200072 (2022). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN200072: Lumipulse G ß-Amyloid Ratio (1-42/1-40), Fujirebio Diagnostics,Inc. (2022) Summary page 11.

## Most influential descendants
- K261686: Elecsys Phospho-Tau (217P) Plasma (2026), 0 descendants of its own

## Recalls of this device
- Dec 11, 2025 · Class II · Z-1301-2026: 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 r
- Dec 11, 2025 · Class II · Z-1304-2026: 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 r
- Dec 11, 2025 · Class II · Z-1302-2026: 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 r
- Dec 11, 2025 · Class II · Z-1306-2026: 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 r
- Dec 11, 2025 · Class II · Z-1303-2026: 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 r
- Dec 11, 2025 · Class II · Z-1305-2026: 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 r
- Dec 11, 2025 · Class II · Z-1307-2026: 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 r

## Indications for use
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.

Source page: https://510kreport.com/device/K242706
Methodology: https://510kreport.com/methodology