# K973331: Vitros Immunodiagnostic Products Ferritin Reagent Pack (Gem.1340), Ferritin Calibrators (Gem.C340)

- Pathway: 510(k) (Traditional)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Oct 22, 1997 after 48 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
VITROS Ferritin Reagent Pack - For the in vitro quantitative measurement of Ferritin in human serum and plasma (heparin). Measurements of Ferritin aid in the diagnosis of diseases affecting iron metabolism such as hemachromatosis (iron overload) and iron deficiency anemia. VITROS Ferritin Calibrators - For in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of Ferritin in human serum and plasma (heparin) VITROS Ferritin Controls - For in vitro use in monitoring the performance of the VITROS Immunodiagnostic System when used for the measurement of Ferritin

Source page: https://510kreport.com/device/K973331
Methodology: https://510kreport.com/methodology