# K092399: Anti-Mutated Citrullinated Vimentin Eia

- Pathway: 510(k) (Traditional)
- Applicant: Orgentec Diagnostika GmbH
- Decided: Jul 1, 2010 after 329 days
- Product code: OQZ (Anti-Mutated Citrullinated Vimentin Igg)
- Device class: 2
- Regulation: 21 CFR 866.5775
- 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 K052133 (2005). 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)
- K052133: Immunoscan RA Anti-CCP Test System, Eurodiagnostica (2005)

## Indications for use
Anti-MCV®D is an indirect solid phase enzyme immunoassay (ELISA) for the qualitative and semi-quantitative measurement of IgO crass auto antibodies against mutated citrullinated vimentin (MCV) in human serum. The assay is intended for in vitro diagnostic use only as an aid in the diagnosis of Rheumatoid Arthritis in conjunction with other laboratory and clinical findings.

Source page: https://510kreport.com/device/K092399
Methodology: https://510kreport.com/methodology