# K973202: Modification of Opus Ferritin Test System

- Pathway: 510(k) (Traditional)
- Applicant: Behring Diagnostics, Inc.
- Decided: Sep 12, 1997 after 66 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 its predicate without a number.
- (no number) Abbott IMX Ferritin: named in the summary without a submission number

## Indications for use
OPUS Ferritin is an in vitro fluorogenic enzyme immunoassay (ELISA) for the quantitative measurement of ferritin in human serum, as an aid in the diagnosis of hemochromatosis (iron overload) and iron deficiency anemia. OPUS Serum Ferritin is intended for use with the OPUS analyzers.

Source page: https://510kreport.com/device/K973202
Methodology: https://510kreport.com/methodology