# K092505: Beckman Coulter Ferritin Reagent, Model: OSR61203

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Dec 11, 2009 after 119 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K191562: Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor (2020), 0 descendants of its own

## Indications for use
The Ferritin Reagent is for the determination of ferritin concentrations in human serum and plasma on the Beckman Coulter family of AU clinical chemistry analyzers. For in vitro diagnostic use only. Serum ferritin is an indicator of body iron stores: it has been shown to correlate with stainable bone marrow iron. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency anemia.

Source page: https://510kreport.com/device/K092505
Methodology: https://510kreport.com/methodology