# K083906: Advia Chemistry Cystatin C Reagent, Advia Chemistry Cystatin C Calibrator, Models P/N 04851534, P/N 10376487

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics
- Decided: Mar 11, 2009 after 71 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: 2 generations back to K003503 (2001). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041878: N Latex Cystatin, Dade Behring, Inc. (2004) Summary page 2.
- K003501: N Protein Standard UY Calibrator, Dade Behring, Inc. (2001) Summary page 2.

## Indications for use
Reagent: For in vitro diagnostic use in the quantitative determination of Cystatin-C (CYSC) in human serum or plasma (lithium heparin, potassium EDTA) on the ADVIA Chemistry systems. Measurement of Cystatin C aids in the diagnosis and treatment of renal disease. Calibrator: For in vitro diagnostic use in the calibration of Cystatin C method on ADVIA Chemistry systems.

Source page: https://510kreport.com/device/K083906
Methodology: https://510kreport.com/methodology