# K181082: ADVIA Chemistry Cystatin C_2 Assay (CYSC_2)

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: May 25, 2018 after 31 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)
- K171072: N Latex Cystatin C; N Protein Standard UY, Siemens Healthcare Diagnostics Products GmbH (2017) Summary page 4.

## Indications for use
The ADVIA® Chemistry Cystatin C_2 (CYSC_2) assay is for the in vitro diagnostic use in the quantitative determination of cystatin C in human serum and plasma (lithium heparin, potassium EDTA) on ADVIA Chemistry systems. Measurement of cystatin C aids in the diagnosis and treatment of renal disease.

Source page: https://510kreport.com/device/K181082
Methodology: https://510kreport.com/methodology