# DEN190056: ADVIA Centaur Enhanced Liver Fibrosis (ELF)

- Pathway: De Novo (Direct)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Aug 20, 2021 after 603 days
- Product code: QQB (Prognostic Test For Assessment Of Liver Related Disease Progression)
- Device class: 2
- Regulation: 21 CFR 862.1622
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
ADVIA Centaur® Enhanced Liver Fibrosis (ELF™) is for in vitro diagnostic use in the determination of an ELF score based on the combined quantitative measurements of hyaluronic acid, amino-terminal propeptide of type III procollagen, and tissue inhibitor of matrix metalloproteinase 1 in human serum using the ADVIA Centaur XP system. ADVIA Centaur ELF is indicated as a prognostic marker in conjunction with other laboratory findings and clinical assessments in patients with advanced fibrosis (F3 or F4) due to non-alcoholic steatohepatitis (NASH), to assess the likelihood of progression to cirrhosis and liver-related clinical events.

Source page: https://510kreport.com/device/DEN190056
Methodology: https://510kreport.com/methodology