# K061165: Elia CCP, Model 14-5515-01; Elia CCP Control, Model 83-1009-01

- Pathway: 510(k) (Traditional)
- Applicant: Sweden Diagnostics (Us), Inc.
- Decided: Aug 3, 2006 after 99 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 K023285 (2002). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023285: Diastat Anti Cyclic Citrullinated Peptide (Anti-CCP) Elisa, Axis-Shield Diagnostics, Ltd. (2002) Summary page 1.

## Most influential descendants
- K151799: EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000 (2016), 0 descendants of its own

## Recalls of this device
- Jan 30, 2017 · Class II · Z-1253-2017: Erroneous EliA test results related to problems with liquid level detection and diluent pipetting in Phadia 250 instruments, and deformed bottles. Investigation showed problems with the liquid level d

## Indications for use
EliA CCP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to cyclic citrullinated peptides (CCP) in human serum and plasma. The presence of anti-CCP antibodies can be used in conjunction with clinical findings and other laboratory tests as an aid in the clinical diagnosis of rheumatoid arthritis (RA). EliA CCP uses the EliA IgG method on the instruments ImmunoCAP 100 and ImmunoCAP 250. EliA CCP Control is intended for laboratory use in monitoring the performance of in vitro measurement of anti-cyclic citrullinated peptide (CCP) antibodies with ImmunoCAP using the EliA IgG method.

Source page: https://510kreport.com/device/K061165
Methodology: https://510kreport.com/methodology