# K080662: Genzyme Cystatin C Reagent Anf Genzyme Cystatin C Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Genzyme Corporation
- Decided: May 15, 2008 after 66 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 1.
- K003501: N Protein Standard UY Calibrator, Dade Behring, Inc. (2001) Summary page 1.

## Indications for use
For the quantitative measurement of cystatin C concentration in human serum, heparinized plasma and EDTA plasma. Cystatin C measurements are used as an aid to the diagnosis and treatment of renal diseases. For In Vitro Diagnostic Use. For the calibration of Genzyme Cystatin C assay. For In Vitro Diagnostic Use.

Source page: https://510kreport.com/device/K080662
Methodology: https://510kreport.com/methodology