# K982714: Bayer Immuno 1 System Ferritin Assay

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Corp.
- Decided: Oct 22, 1998 after 79 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. The FDA summary names no predicate by number.

## Indications for use
This in vitro diagnostic method is intended to quantitatively measure ferritin (an iron-storage protein) in human serum on the Bayer Immuno 1 System. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency anemia. This diagnostic method is not intended for use on any other system.

Source page: https://510kreport.com/device/K982714
Methodology: https://510kreport.com/methodology