# K050266: Direct Bilirubin Liquicolor and Total Bilirubin Liquicolor

- Pathway: 510(k) (Traditional)
- Applicant: Stanbio Laboratory
- Decided: Jun 30, 2005 after 146 days
- Product code: JFM (Enzymatic Method, 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 K910593 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910593: Roche Reagent for Direct Bilirubin, Roche Diagnostic Systems, Inc. (1991) Summary page 1.
- K910591: Roche Reagent for Total Bilirubin, Roche Diagnostic Systems, Inc. (1991) Summary page 1.

## Indications for use
The Stanbio Direct Bilirubin LiquiColor® and Total Bilirubin LiquiColor® test systems are devices intended to measure the levels of bilirubin (direct and total) in serum and plasma. Measurements of the levels of bilirubin, and organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder block.

Source page: https://510kreport.com/device/K050266
Methodology: https://510kreport.com/methodology