# K242585: Cystatin C

- Pathway: 510(k) (Traditional)
- Applicant: SENTINEL CH. SpA
- Decided: May 16, 2025 after 259 days
- Product code: NDY (Test, Cystatin C)
- Device class: 2
- Regulation: 21 CFR 862.1225
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K953239 (1995). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161817: Tina-quant Cystatin C Gen.2, Roche Diagnostics Operations (Rdo) (2016) Summary page 6.

## Indications for use
The Cystatin C assay is an in vitro diagnostic test used in the quantitative immunoturbidimetric determination of cystatin C in human serum and plasma on the Alinity c system. Measurement of cystatin C aids in the diagnosis and treatment of renal diseases. For laboratory professional use only.

Source page: https://510kreport.com/device/K242585
Methodology: https://510kreport.com/methodology