# K061751: Dimension Vista System Ucfp Calibrator, Model KC260

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Jul 13, 2006 after 22 days
- Product code: JIT (Calibrator, Secondary)
- Device class: 2
- Regulation: 21 CFR 862.1150
- 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 K934843 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934843: Urinary/Cebrospinal Fluid Protein Calibrator, E.I. Dupont DE Nemours & Co., Inc. (1994) Summary page 1.

## Indications for use
The UCFP CAL is an in vitro diagnostic product for the calibration of Urinary/Cerebrospinal Fluid Protein (UCFP) method on the Dimension Vista™ System.

Source page: https://510kreport.com/device/K061751
Methodology: https://510kreport.com/methodology