# K170065: ADVIA® Chemistry Total Bilirubin_2 (TBIL_2)

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Mar 9, 2017 after 59 days
- Product code: JFM (Enzymatic Method, Bilirubin)
- Device class: 2
- Regulation: 21 CFR 862.1110
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K910591 (1991). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150510: Total Bilirubin, Abbott Laboratories (2015) Summary page 4.

## Recalls of this device
- Jul 10, 2023 · Class II · Z-2471-2023: Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator results with from Atellica¿ CH Total Bilirub
- Feb 13, 2020 · Class II · Z-1539-2020: Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy

## Indications for use
For in vitro diagnostic use in the quantitative determination of total bilirubin in serum and plasma of adults and neonates on the ADVIA® Chemistry systems. 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. 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/K170065
Methodology: https://510kreport.com/methodology