# K012393: Tina-Quant Transferrin Ver.2

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Sep 19, 2001 after 54 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: 1 generation back to K951595 (1995). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951595: Roche Cobas Integra Analyzer, Reagent Cassettes, Roche Diagnostic Systems, Inc. (1995) Summary page 2.

## Most influential descendants
- K191562: Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor (2020), 0 descendants of its own
- K063766: Transferrin Tia , Calibrator Set, Control-L,Control-M,Control-H, Model# KT-0105-a,CA-0105-a,B,C (2007), 0 descendants of its own

## Indications for use
The cassette COBAS Integra Tina-quant Transferrin ver.2 contains an in vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative immunological determination of human transferrin in serum and plasma. 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 serum and plasma. 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/K012393
Methodology: https://510kreport.com/methodology