# K053075: N Antisera to Human Transferrin

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Mar 16, 2006 after 135 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 K926272 (1993). 2 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972840: N Antiserum to Human Transferrin, Behring Diagnostics, Inc. (1997) Summary page 1.

## Most influential descendants
- K182095: Tina-quant Transferrin ver.2 (urine application) (2018), 0 descendants of its own
- K081299: Dimension Vista System TRF Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator, and Dimension Vista (2008), 0 descendants of its own
- K063322: Dimension Vista TRF Flex Reagent Cartridge, Protein 1 Calibrator Protein 1 Control L,Control M, Control H (2007), 0 descendants of its own

## Indications for use
In vitro diagnostic reagents for the quantitative determination of transferrin in human serum, heparinized and EDTA plasma, as well as transferrin in human urine by means of immunonephelometery on the BNTM Systems. 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/K053075
Methodology: https://510kreport.com/methodology