# K120236: Transferrin Kit for Use on the Spaplus

- Pathway: 510(k) (Traditional)
- Applicant: The Binding Site Group, Ltd.
- Decided: Feb 13, 2013 after 384 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Binding Site Human Transferrin Kit is intended for the quantitative determination of human transferrin using the Binding Site SPAPLUS turbidimetric analyzer in human serum. The measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection and iron deficiency anemia. This test should be used in conjunction with other laboratory and clinical findings

Source page: https://510kreport.com/device/K120236
Methodology: https://510kreport.com/methodology