# K103824: Human Iga Liquid Reagent Kit for Use on Spa Plus

- Pathway: 510(k) (Traditional)
- Applicant: The Binding Site
- Decided: Feb 27, 2012 after 424 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: 2 generations back to K955907 (1996). 2 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040435: Roche Diagnostics Tina-Quant Iga Gen.2, Roche Diagnostics Corp. (2004) Summary page 1.

## Most influential descendants
- K191985: Optilite IgA Kit (2019), 1 descendant of its own
- K250159: Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser (2025), 0 descendants of its own
- K192116: Human IgA liquid reagent kit for Use on SPAPlus (2019), 0 descendants of its own

## Indications for use
This kit is intended for the quantitative int 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/K103824
Methodology: https://510kreport.com/methodology