# K971958: Synchron LX Systems Transferrin (TRFN) Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Instruments, Inc.
- Decided: Aug 20, 1997 after 84 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 K780913 (1978). 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)
- K780913: Additional Reagents Kits for Imm. System, Beckman Instruments, Inc. (1978) Summary page 1.

## Indications for use
The SYNCHRON LX Systems Transferrin (TRFN) Reagent, when used in conjunction with SYNCHRON LX Calibrator 1, is intended for the quantitative determination of human transferrin in serum or plasma. This assay is designed for use with clinical chemistry analyzers from Beckman instruments, such as the SYNCHRON LX20 Clinical System. The measurement of transferrin in serum or other body fluids aids in the diagnosis of malnutrition, acute inflammation, infection, assessment of renal function and red blood cell disorders, such as iron deficiency anemia.

Source page: https://510kreport.com/device/K971958
Methodology: https://510kreport.com/methodology