# K040879: Quantex Ferritin

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: May 10, 2004 after 35 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 K935847 (1994). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K935847: Axsym Ferritin, Abbott Laboratories (1994) Summary page 1.

## Most influential descendants
- K052617: Ferritin Lit Assay, Catalog NO. 7010; Ferritin Calibrator Set, Catalog NO. 7510; Ferritin Controls, Level-L & Level-H, (2006), 0 descendants of its own

## Indications for use
Quantex Ferritin is intended as a latex particle enhanced immunoturbidimetric assay for the quantitative determination of ferritin in human serum or EDTA plasma on Clinical Chemistry Systems, and aids in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency anemia. The quantex Ferritin controls I/1l are intended for use in monitoring the quality control of results obtained with the quantex Ferritin reagents by turbidimetry. The quantex Ferritin standard multipoint is intended for use in establishing the calibration curve for the quantex Ferritin reagents by turbidimetry.

Source page: https://510kreport.com/device/K040879
Methodology: https://510kreport.com/methodology