# K972840: N Antiserum to Human Transferrin

- Pathway: 510(k) (Traditional)
- Applicant: Behring Diagnostics, Inc.
- Decided: Oct 17, 1997 after 77 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 K926272 (1993). 1 ancestor in all.
4 later devices descend from it; 1 cites 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)
- K926272: Beckman Transferrin Kit, Beckman Instruments, Inc. (1993) Summary page 1.

## Most influential descendants
- K053075: N Antisera to Human Transferrin (2006), 3 descendants of its own
- 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
N Antiserum to Human Transferrin is an in vitro diagnostic reagent intended to be used together with the Behring Nephelometer Systems in the measurement of transferrin in human serum and urine, used as an aid in the diagnosis of latent and manifest iron deficiency and iron overload, and glomerular defects.

Source page: https://510kreport.com/device/K972840
Methodology: https://510kreport.com/methodology