# K182095: Tina-quant Transferrin ver.2 (urine application)

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Operations (Rdo)
- Decided: Nov 5, 2018 after 94 days
- Product code: DDG (Transferrin, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5880
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K926272 (1993). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053075: N Antisera to Human Transferrin, Dade Behring, Inc. (2006) Summary page 4.

## Indications for use
Tina-quant Transferrin ver.2 (urine application) assay is an in vitro test for the quantitative determination of transferrin in human urine on Roche/Hitachi cobas c systems. A transferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the transferrin (an iron-binding and transporting serum protein) in urine. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.

Source page: https://510kreport.com/device/K182095
Methodology: https://510kreport.com/methodology