# K050944: K-Assay Ferritin (2) & Ferritin Calibrator Set

- Pathway: 510(k) (Traditional)
- Applicant: Kamiya Biomedical Co.
- Decided: Dec 23, 2005 after 253 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.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K113437: Ace Hemoglobin Alc (Hbalc) Reagent, Ace Cedia T Uptake Reagent, Ace T4 Reagent, Ace Ferritin Reagent (2012), 1 descendant of its own
- K131515: Ace -GT Reagent; Ace Lipase Ragent; Ace T4 Reagent (2013), 0 descendants of its own
- K121232: K-Assay (R) Ferritin Reagent, K-Assay (R) Ferritin Calibrator (2012), 0 descendants of its own

## Indications for use
The K-ASSAY® Ferritin (2) 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 Roche / Hitachi 917 analyzer. 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 Set is an in vitro diagnostic reagent for calibration of the K-ASSAY® Ferritin (2) Assay. For in vitro diagnostic use.

Source page: https://510kreport.com/device/K050944
Methodology: https://510kreport.com/methodology