# K193650: LIAISON Ferritin

- Pathway: 510(k) (Traditional)
- Applicant: DiaSorin, Inc.
- Decided: Sep 14, 2021 after 624 days
- Product code: DBF (Ferritin, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K971833 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971833: Elecsys Ferritin, Boehringer Mannheim Corp. (1997) Summary page 4.

## Indications for use
The DiaSorin LIAISON@ Ferritin assay is a quantitative automated chemiluminescent immunoassay (CLIA) for the in vitro detection of ferritin in human serum, serum separator tubes (SST), or lithium (Li) heparin plasma to aid in the diagnosis of iron deficiency anemia and iron overload. This assay must be performed on the LIAISON® XL Analyzer.

Source page: https://510kreport.com/device/K193650
Methodology: https://510kreport.com/methodology