# K052133: Immunoscan RA Anti-CCP Test System

- Pathway: 510(k) (Traditional)
- Applicant: Eurodiagnostica
- Decided: Dec 12, 2005 after 129 days
- Product code: NHX (Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp))
- 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
No predicates in its family tree.
8 later devices descend from it; 4 cite it directly.
0 of 9 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
- K081338: Roche Elecsys Anti-CCP Immunoassay, Roche Elecsys Precicontrol Anti-CCP (2008), 4 descendants of its own
- K121895: Elecsys HSV-2 Igg Immunoassay (2012), 1 descendant of its own
- K120625: Elecsys HSV-1 Igg Immunoassay Elecsys Precicontrol HSV (2012), 1 descendant of its own
- K220923: Elecsys HSV-1 IgG (08948844160) (2022), 0 descendants of its own
- K220924: Elecsys HSV-2 IgG (08948887160) (2022), 0 descendants of its own

## Indications for use
The Immunoscan RA anti-CCP test kit is an enzyme-linked immunosorbent assay (ELISA) for detection and semi-quantitation of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human sera. The assay is used to detect antibodies in a single serum specimen. The results of the assay are to be used as an aid to the diagnosis of Rheumatoid Arthritis (RA), in conjunction with other laboratory and clinical findings. The analysis should be performed by trained laboratory professionals.

Source page: https://510kreport.com/device/K052133
Methodology: https://510kreport.com/methodology