# K063351: Dimension Vista Cysc Flex Reagent Cartridge, Protein 3 Calibrator and Cystatin Control Low and High

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Jan 22, 2007 after 77 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
The CYSC method is an in vitro diagnostic test for the quantitative determination of cystatin C in human serum, heparinized plasma or EDTA plasma on the Dimension Vista® System. Cystatin C measurements are used in the diagnosis and treatment of renal diseases. The PROT3 CAL is an in vitro diagnostic product for the calibration of the Cystatin C (CYSC) and Microalbumin (MALB) methods on the Dimension Vista® System. CYSC CON L and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in determination of cystatin C (CYSC) on the Dimension Vista® System.

Source page: https://510kreport.com/device/K063351
Methodology: https://510kreport.com/methodology