# K222104: Atellica® CH Diazo Total Bilirubin (D_TBil)

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Mar 20, 2023 after 245 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: 2 generations back to K861700 (1986). 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)
- K060628: Dimension Tbi Flex and Dbi Flex Reagent Cartridges and Tbi/Dbi Calibrator, Dade Behring, Inc. (2006) Summary page 4.

## Indications for use
The Atellica® CH Diazo Total Bilirubin (D_TBil) assay is for in vitro diagnostic use in the quantitative determination of total bilirubin in adults and children (non-neonates) in human serum and plasma using the Atellica® CH Analyzer. Measurement of total 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/K222104
Methodology: https://510kreport.com/methodology