# K983759: Abbott Architect Ferritin

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Dec 7, 1998 after 42 days
- Product code: DBF (Ferritin, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5340
- Recalls of this device: 2 (0 Class I)
- 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) AxSYM Ferritin assay: named in the summary without a submission number

## Recalls of this device
- Nov 21, 2018 · Class II · Z-2208-2019: Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in Appendix A. If a bottle neck is damaged, it ma
- Jun 6, 2006 · Not classified · Z-1204-06: Some ARCHITECT Ferritin Reagent lots may not be meeting the accuracy by correlation to AxSYM claims as they are listed in the package insert (slope of 1.0 +/- 0.2).

## Indications for use
The Abbott ARCHITECT™ Ferritin assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of ferritin in human serum and plasma on the Abbott ARCHITECT i System. Measurements obtained by this device aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency anemia.

Source page: https://510kreport.com/device/K983759
Methodology: https://510kreport.com/methodology