# K120901: Human Iga CSF Kit for Use on Spaplus

- Pathway: 510(k) (Traditional)
- Applicant: The Binding Site Group, Ltd.
- Decided: May 30, 2013 after 430 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
Human IgA CSF Kit for use on SPAPLUS is intended for the quantitative measurement of human igA in cerebrospinal fluid (CSF) samples using the SPAptUs analyser. Measurement of this immunoglobulin aids in the assessment of the body's rack of ability to resist infectious disease in conjunction with other clinical and laboratory findings.

Source page: https://510kreport.com/device/K120901
Methodology: https://510kreport.com/methodology