# K081827: Human Iga Liquid Reagent Kit for Use on Spaplus

- Pathway: 510(k) (Traditional)
- Applicant: The Binding Site, Ltd.
- Decided: Dec 19, 2008 after 175 days
- Product code: CFN (Method, Nephelometric, Immunoglobulins (G, A, M))
- Device class: 2
- Regulation: 21 CFR 866.5510
- 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
This kit is intended for the quantitative in vitro determination of human IgA in serum, lithium heparin or EDTA plasma, using the Binding Site SPAPLUS T M turbidimetric analyser. Measurement of IgA aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. The test results are to be used in conjunction with other clinical and laboratory findings.

Source page: https://510kreport.com/device/K081827
Methodology: https://510kreport.com/methodology