# K003064: Tina-Quant Soluble Transferrin Receptor Test System, Hitachi Catalog # 2148315; Integra Catalog # 2148323

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: May 1, 2001 after 211 days
- Product code: DDG (Transferrin, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5880
- Recalls of this device: 3 (0 Class I)
- 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Aug 28, 2019 · Class II · Z-0108-2020: Tina-quant Soluble Transferrin Receptor (STFR) Assays Updated Claims for Rheumatoid Factors Interference
- Aug 28, 2019 · Class II · Z-0109-2020: Tina-quant Soluble Transferrin Receptor (STFR) Assays Updated Claims for Rheumatoid Factors Interference
- Jun 11, 2008 · Not classified · Z-0009-2009: Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader.

Source page: https://510kreport.com/device/K003064
Methodology: https://510kreport.com/methodology