# K121232: K-Assay (R) Ferritin Reagent, K-Assay (R) Ferritin Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Kamiya Biomedical Company
- Decided: May 24, 2012 after 30 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 K050944 (2005). 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)
- K050944: K-Assay Ferritin (2) & Ferritin Calibrator Set, Kamiya Biomedical Co. (2005) Summary page 2.

## Indications for use
The K-ASSAY 0 Ferritin (2nd Gen.) assay is an in vitro diagnostic reagent for the quantitative determination of ferritin (an iron-storing protein) in human serum and plasma by immunoturbidimetric assay on the Beckman AU680. Measurements of ferritin aid in the diagnosis of diseases affecting iron overload and iron deficiency anemia. FOR IN VITRO DIAGNOSTIC USE. The K-ASSAY ® Ferritin Calibrator (2nd Gen.) is an in vitro diagnostic reagent for calibration of the K-ASSAY® Ferritin (2nd Gen.) assay. FOR IN VITRO DIAGNOSTIC USE.

Source page: https://510kreport.com/device/K121232
Methodology: https://510kreport.com/methodology