# K171072: N Latex Cystatin C; N Protein Standard UY

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics Products GmbH
- Decided: May 12, 2017 after 32 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: 4 generations back to K953239 (1995). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141143: Cobas C Tina-Quant Cystatin C Gen.2 Assay, C.F.a.S. Cystatin C Calibrator, Cystatin C Gen.2 Control Set, Roche Diagnostics (2014) Summary page 4.

## Most influential descendants
- K181082: ADVIA Chemistry Cystatin C_2 Assay (CYSC_2) (2018), 0 descendants of its own

## Indications for use
N Latex Cystatin C: N Latex Cystatin C is an in vitro diagnostics kit containing reagents for the quantitative determination of cystatin C in human serum and lithium-heparinized plasma by means of particle-enhanced immunonephelometry using the BN Systems. Cystatin C measurements are used in the diagnosis and treatment of renal diseases. N Protein Standard UY: N Protein Standard UY is used for preparing reference curves for the immunonephelometric determination of α1-microglobulin and Cystatin C using the BN Systems.

Source page: https://510kreport.com/device/K171072
Methodology: https://510kreport.com/methodology