# K062787: Elia Celikey Iga Well, Model 14-5517-01; Elia Celiac Control, Model 83-1011-01

- Pathway: 510(k) (Traditional)
- Applicant: Phadia US, Inc.
- Decided: Dec 29, 2006 after 102 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 K041174 (2004). 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)
- K041174: Celikey TTG (Human, Recombinant) Iga Antibodies Model #18148/18196, Sweden Diagnostics (Germany) GmbH (2004) Summary page 1.

## Indications for use
EliA Celiac Control is intended for laboratory use in monitoring the performance of in vitro measurement of antibodies to tissue transglutaminase (tTG) with ImmunoCAP 100 or 250 using the EliA IgG or IgA method. EliA Celikey IgA Immunoassay is intended for the in vitro semi-quantitative measurement of IgA antibodies directed to tissue transglutaminase (tTG) in human serum and plasma (EDTA, citrate). EliA Celikey IgA Immunoassay is based on recombinant human tissue transglutaminase as antigen and is useful as an aid in the clinical diagnosis of patients with celiac disease, in conjunction with other laboratory and clinical findings. EliA Celikey IgA Immunoassay uses the EliA IgA method on the instrument ImmunoCAP 100 and ImmunoCAP 250.

Source page: https://510kreport.com/device/K062787
Methodology: https://510kreport.com/methodology