# K100538: Tina-Quant Ferritin Gen. 4

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Jun 22, 2010 after 117 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: 2 generations back to K860137 (1986). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964282: Tina-Quant Ferritin Assay, Boehringer Mannheim Corp. (1997) Summary page 2.

## Indications for use
Immunological in vitro immunoturbidometric test for the quantitative determination of ferritin in human serum and plasma using Roche/Hitachi clinical chemistry analyzers. Measurements obtained by this device are used in the aid of diagnosis of diseases affecting iron metabolism in conjunction with other clinical and laboratory findings.

Source page: https://510kreport.com/device/K100538
Methodology: https://510kreport.com/methodology