# K093908: Ccpoint

- Pathway: 510(k) (Traditional)
- Applicant: Euro-Diagnostica AB
- Decided: Dec 1, 2010 after 344 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
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.

## Indications for use
The Euro-Diagnostica CCPoint® test is a visually read, qualitative rapid lateral flow test for the detection of IgG antibodies to Cyclic Citrullinated Peptides (COP) in human plasma or serum. The results of the test are to be used as an aid to the diagnosis of Rheumatoid Arthritis (RA), in conjunction with other laboratory and clinical findings. For use by trained laboratory professionals. For in-vitro diagnostic use.

Source page: https://510kreport.com/device/K093908
Methodology: https://510kreport.com/methodology