# K063766: Transferrin Tia , Calibrator Set, Control-L,Control-M,Control-H, Model# KT-0105-a,CA-0105-a,B,C

- Pathway: 510(k) (Traditional)
- Applicant: Good Biotech Corp.
- Decided: Apr 23, 2007 after 124 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: 2 generations back to K951595 (1995). 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)
- K012393: Tina-Quant Transferrin Ver.2, Roche Diagnostics Corp. (2001) Summary page 1.

## Indications for use
Good Biotech Corp. Transferrin test system is intended to be used for the quantitative determination of transferrin in human serum by turbidimetric immunoassay (TIA). Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia Good Biotech Corp. Transferrin Calibrator Set is intended to be used with Transferrin TIA for the quantitative determination of transferrin in serum samples. Good Biotech Corp. Transferrin Controls are intended to be used as the assayed quality control material for transferrin analysis. For In Vitro Diagnostic Use.

Source page: https://510kreport.com/device/K063766
Methodology: https://510kreport.com/methodology