# K974505: Auraflex Ferritin 200 Test Pack 80500, Auraflex Ferritin Calibrator Pack 80501

- Pathway: 510(k) (Traditional)
- Applicant: Alfa Biotech (Uk), Ltd.
- Decided: Feb 17, 1998 after 78 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) Other Ferritin assay: named in the summary without a submission number

## Indications for use
AuraFlex Ferritin is a fluorcscent enzyme immunoassay for the quantitative determination of ferritin in human serum or plasma using the AuraFlex System. Mecasurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemachromatosis (iron overload) and iron deficiency anemia.

Source page: https://510kreport.com/device/K974505
Methodology: https://510kreport.com/methodology