# K031650: Ferritin Generation 2

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Jul 17, 2003 after 50 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: 2 generations back to K850281 (1985). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963292: Cobas Integra Reagent Cassettes & Ancillary Reagents, Roche Diagnostic Systems, Inc. (1996) Summary page 1.

## Indications for use
In vitro diagnostic reagent system intended for use on COBAS INTEGRA system for the quantitative immunological determination of human ferritin in serum and plasma. 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/K031650
Methodology: https://510kreport.com/methodology