# K192116: Human IgA liquid reagent kit for Use on SPAPlus

- Pathway: 510(k) (Special)
- Applicant: The Binding Site Group, Ltd.
- Decided: Sep 4, 2019 after 29 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
Longest line of descent: 3 generations back to K955907 (1996). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103824: Human Iga Liquid Reagent Kit for Use on Spa Plus, The Binding Site (2012) Summary page 5.

## 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 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/K192116
Methodology: https://510kreport.com/methodology