# K183151: Optilite IgA CSF Kit

- Pathway: 510(k) (Traditional)
- Applicant: The Binding Site Group, Ltd.
- Decided: Jan 23, 2019 after 70 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 K771603 (1977). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993549: Beckman Coulter Immage Immunochemistry System Low Concentration Immunoglobulin a (Igalc) Reagent, Beckman Coulter Cerebr, Beckman Coulter, Inc. (2000) Summary page 5.

## Indications for use
The Optilite IgA CSF Kit is intended for the quantitative in vitro measurement of IgA in cerebrospinal fluid (CSF) using the Optilite analyser.

Source page: https://510kreport.com/device/K183151
Methodology: https://510kreport.com/methodology