# K062583: Elia Celikey Igg Well, Model 14-5518-01, Elia Celiac Control, Model 83-1011-01

- Pathway: 510(k) (Traditional)
- Applicant: Phadia US, Inc.
- Decided: Dec 26, 2006 after 116 days
- Product code: MVM (Autoantibodies, Endomysial(Tissue Transglutaminase))
- Device class: 2
- Regulation: 21 CFR 866.5660
- 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 K041173 (2004). 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)
- K041173: Celikey Igg Itg Igg Antibodies, Model 17996, Sweden Diagnostics (Germany) GmbH (2004) Summary page 1.

## Most influential descendants
- K181871: EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG Immunoassay (2019), 0 descendants of its own

## Indications for use
EIiA Celikey IgG is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to tissue transglutaminase (tTG) in human serum and plasma. EliA Celikey IgG is based on recombinant human tissue transglutaminase as the antigen and is useful as an aid in the clinical diagnosis of patients with celiac disease. EIiA Celikey IgG uses the EliA IgG method on the instrument InmmunoCAP 100 and ImmunoCAP 250.

Source page: https://510kreport.com/device/K062583
Methodology: https://510kreport.com/methodology