# K984186: Nichols Advantage Chemiluminescence Ferritin Immunoassay

- Pathway: 510(k) (Traditional)
- Applicant: Nichols Institute Diagnostics
- Decided: Feb 2, 1999 after 71 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: 1 generation back to K905770 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K905770: Ciba Corning Acs Ferritin Immunoassay, Ciba Corning Diagnostics Corp. (1991) Summary page 1.

## Indications for use
The Nichols Advantage® Chemiluminescence Ferritin Immunoassay is designed for use with the Nichols Advantage® Specialty System for the quantitative determination of ferritin in hunan serum or plasma. This assay is intended to aid in the diagnosis of iron deficiency anemia and iron overload.

Source page: https://510kreport.com/device/K984186
Methodology: https://510kreport.com/methodology