# K061839: Dimension Vista Dbil Flex Reagent Cartridge, Model K2125

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Aug 29, 2006 after 61 days
- Product code: CIG (Diazo Colorimetry, Bilirubin)
- Device class: 2
- Regulation: 21 CFR 862.1110
- 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 K862359 (1986). 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)
- K862359: Meth./Cali./Intru. Check for the Dimension System, E.I. Dupont DE Nemours & Co., Inc. (1986) Summary page 1.

## Indications for use
The DBIL method is an in vitro diagnostic test for the quantitative measurement of direct (conjugated) bilirubin in human serum and plasma on the Dimension Vista System. Measurements of direct bilirubin are used in the diagnosis and treatment of liver, hemolytic, hematological and metabolic disorders, including hepatitis and gall bladder disease.

Source page: https://510kreport.com/device/K061839
Methodology: https://510kreport.com/methodology