# K963976: Immunochemistry Sys Urine Transferrin Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Instruments, Inc.
- Decided: Mar 19, 1997 after 166 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.
No later device cites it as a predicate yet.
0 of 2 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.

## Indications for use
The IMMAGE Immunochemistry System Urine Transferrin (TRU) reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Urine Protein Calibrator, is intended for the quantitative determination of transferin in urine by rate nephelometry.

Source page: https://510kreport.com/device/K963976
Methodology: https://510kreport.com/methodology