# K251998: Atellica CH Diazo Total Bilirubin (D_TBil)

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Feb 27, 2026 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: 4 generations back to K781921 (1979). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131544: Cobas C Bilirubin Total Gen.3, Roche Diagnostics (2013) Summary page 5.

## 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 human serum and plasma of adults and neonates 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 gallbladder block. A total bilirubin measurement in newborn infants is intended to aid in indicating the risk of bilirubin encephalopathy (kernicterus).

Source page: https://510kreport.com/device/K251998
Methodology: https://510kreport.com/methodology