Class Class II
Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF (K231348)
Description
Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF by Roche Diagnostics, an FDA 510(k) cleared immunology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK231348
Clearance Date2023-06-05
Clearance TypeTraditional
Product CodeQSE
Regulation Number866.5840
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K231348
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. Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF (K231348) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K221842 | Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P)... | Roche Diagnostics | 2022 |
Trace the full predicate network for K231348
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.