# K133083: Diazyme Ferritin Assay, Diazyme Ferritin Calibrator Set, Diazyme Ferritin Control Set

- Pathway: 510(k) (Traditional)
- Applicant: Diazyme Laboratories
- Decided: Jun 24, 2014 after 267 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Diazyme Ferritin Assay is for the quantitative determination of fierritin in human serum, K2EDTA plasma, and lithium heparin plasma on Hitachi 917 analyzer. For in vitro diagnostic use only The Diazyme Ferritin Calibrator Set is intended for use in the calibration of the Diazyme Ferritin Assay. For in vitro diagnostic use only. The Diazyme Ferritin Control Set is intended for use as quality controls for the Diazyme Ferritin Assay. For in vitro diagnostic use only.

Source page: https://510kreport.com/device/K133083
Methodology: https://510kreport.com/methodology