# K120750: Human Igm CSF Kit

- Pathway: 510(k) (Traditional)
- Applicant: The Binding Site Group, Ltd.
- Decided: May 17, 2013 after 431 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K190686: Optilite IgM CSF Kit (2019), 0 descendants of its own

## Indications for use
Human 1gM CSF kit for use on SPAPLUS is intended for the quantitative measurement of human 1gM in cerebrospinal fluid (CSF) samples using the SPAPLUS analyser. Measurement of this immunogiobulin aids in the assessment of the body's lack of ability to resist infectious disease in conjunction with other clinical and laboratory findings.

Source page: https://510kreport.com/device/K120750
Methodology: https://510kreport.com/methodology