# K190686: Optilite IgM CSF Kit

- Pathway: 510(k) (Traditional)
- Applicant: The Binding Site Group, Ltd.
- Decided: May 28, 2019 after 71 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: 1 generation back to K120750 (2013). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120750: Human Igm CSF Kit, The Binding Site Group, Ltd. (2013) Summary page 5.

## Indications for use
The Optilite IgM CSF Kit is intended for the quantitative in vitro measurement of I[gM in cerebrospinal fluid (CSF) samples using the Optilite analyser.

Source page: https://510kreport.com/device/K190686
Methodology: https://510kreport.com/methodology