# K063845: Advia Chemistry Total Bilirubin_2

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Healthcare, LLC
- Decided: Dec 7, 2007 after 345 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 K992399 (1999). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992399: Additional Ims Assays for the Bayer Advia Ims System, Bayer Corp. (1999) Summary page 1.

## Most influential descendants
- K152344: Total Bilirubin (2016), 0 descendants of its own

## Indications for use
For in vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma on the ADVIA Chemistry Systems. Such measurements are used in the diagnosis and treatment of hemolytic, biliary, and liver disorders, including hepatitis and cirrhosis.

Source page: https://510kreport.com/device/K063845
Methodology: https://510kreport.com/methodology