# K091657: Immunoscan Ccplus

- Pathway: 510(k) (Traditional)
- Applicant: Euro-Diagnostica AB
- Decided: Nov 19, 2009 after 163 days
- Product code: NHX (Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp))
- Device class: 2
- Regulation: 21 CFR 866.5775
- Recalls of this device: 1 (0 Class I)
- 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) Summary page 1.

## Recalls of this device
- Feb 14, 2016 · Class II · Z-2918-2018: Decreasing performance overtime.

## Indications for use
The Immunoscan CCPlus® test kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative and semi-quantitative determination 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. "For in vitro diagnostic use".

Source page: https://510kreport.com/device/K091657
Methodology: https://510kreport.com/methodology