Class Class II
Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio (K242706)
Description
Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio by Fujirebio Diagnostics,Inc., an FDA 510(k) cleared immunology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242706
Clearance Date2025-05-16
Clearance TypeTraditional
Product CodeSET
Regulation Number866.5840
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242706
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio (K242706) cites 0 predicate devices and is itself cited by 1 later device.
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K261686 | Elecsys Phospho-Tau (217P) Plasma | Roche Diagnostics | 2026 |
Trace the full predicate network for K242706
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.