# K191985: Optilite IgA Kit

- Pathway: 510(k) (Special)
- Applicant: The Binding Site Group, Ltd.
- Decided: Aug 19, 2019 after 25 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.
1 later device descends from it; 1 cites it directly.
0 of 5 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.

## Most influential descendants
- K250159: Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser (2025), 0 descendants of its own

## Indications for use
The Optilite IgA Kit is intended for the quantitative in vitro measurement of IgA in serum, lithium heparin or EDTA plasma using the Binding Site Optilite analyser, Measurement of IgA aids in the diagnosis of abnormal protein metabolism and the body’s lack of ability to resist infectious agents. This test should be used in conjunction with other laboratory and clinical findings.

Source page: https://510kreport.com/device/K191985
Methodology: https://510kreport.com/methodology