# K041878: N Latex Cystatin

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Aug 16, 2004 after 35 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: 1 generation back to K003503 (2001). 1 ancestor in all.
3 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003503: N Latex Cystatin C, Dade Behring, Inc. (2001) Summary page 1.

## Most influential descendants
- K083906: Advia Chemistry Cystatin C Reagent, Advia Chemistry Cystatin C Calibrator, Models P/N 04851534, P/N 10376487 (2009), 0 descendants of its own
- K080662: Genzyme Cystatin C Reagent Anf Genzyme Cystatin C Calibrator (2008), 0 descendants of its own
- K063351: Dimension Vista Cysc Flex Reagent Cartridge, Protein 3 Calibrator and Cystatin Control Low and High (2007), 0 descendants of its own

## Indications for use
N Latex Cystatin C is an in vitro diagnostics kit containing reagents for the quantitative determination of cystatin C in human serum and heparinized plasma by means of particle-enhanced immunonephelometry using BNTM Systems. Cystatin C measurements are used in the diagnosis and treatment of renal diseases.

Source page: https://510kreport.com/device/K041878
Methodology: https://510kreport.com/methodology