# K223078: Atellica® CH Diazo Direct Bilirubin (D_DBil)

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Jun 12, 2023 after 255 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: 3 generations back to K912024 (1991). 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)
- K053132: Wako Direct Bilirubin V, Models 996-23591, 412-22901, 992-23691, 998-23791, Wako Chemicals USA, Inc. (2005) Summary page 4.

## Indications for use
The Atellica® CH Diazo Direct Bilirubin (D_DBil) assay is for in vitro diagnostic use in the quantitative determination of direct bilirubin in human serum and plasma using the Atellica® CH Analyzer. Measurement of direct bilirubin, an 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/K223078
Methodology: https://510kreport.com/methodology