# K100017: Euroimmun Hippocampus/Cerebellum/Glutamate Receptor/Ifa Biochip Mosaic Test System

- Pathway: 510(k) (Traditional)
- Applicant: Euroimmun Us, Inc.
- Decided: Sep 13, 2010 after 252 days
- Product code: OSK (Anti-Glutamate Receptor (Type Nmda) Ifa)
- Device class: 2
- Regulation: 21 CFR 866.5660
- 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 K083850 (2009). 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)
- K083850: Euroimmun Anca Ifa Europlus Granulocyte Biochip Mosaic Test Systems, Euroimmun Us, Inc. (2009) Summary page 2.

## Indications for use
The EUROIMMUN Anti-Glutamate receptor (type NMDA) IFA is intended for the qualitative determination of autoantibodies against glutamate receptor (type NMDA) in human serum. It is used as an aid in the diagnosis of anti-glutamate receptor (type NMDA) autoimmune encephalitis in conjunction with other laboratory and clinical findings.

Source page: https://510kreport.com/device/K100017
Methodology: https://510kreport.com/methodology