Class Class II
Cystatin C (K242585)
Description
Cystatin C by SENTINEL CH. SpA, an FDA 510(k) cleared clinical chemistry device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242585
Clearance Date2025-05-16
Clearance TypeTraditional
Product CodeNDY
Regulation Number862.1225
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242585
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. Cystatin C (K242585) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K161817 | Tina-quant Cystatin C Gen.2 | Roche Diagnostics Operations (Rdo) | 2016 |
Trace the full predicate network for K242585
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.