# K053211: Rdi Hsferritin Kit

- Pathway: 510(k) (Traditional)
- Applicant: Reference Diagnostics, Inc.
- Decided: Mar 13, 2006 after 117 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.
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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
For in vitro diagnostic use only. The RDI Ferritin Kit is for the quantitative determination of Ferritin in human serum or plasma by immunoturbidimetric measurement. Measurement of ferritin is useful in assessing iron stores and in the evaluation of iron deficiency anemia and hemochromatosis.

Source page: https://510kreport.com/device/K053211
Methodology: https://510kreport.com/methodology