# K063775: Elia Gliadin Iga, Igg and Celiac Control

- Pathway: 510(k) (Traditional)
- Applicant: Phadia US, Inc.
- Decided: Mar 14, 2007 after 83 days
- Product code: MST (Antibodies, Gliadin)
- Device class: 2
- Regulation: 21 CFR 866.5750
- 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 K041354 (2004). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041354: Varelisa Gliadin Iga Antibodies Model #19848/19896, Sweden Diagnostics (Germany) GmbH (2004) Summary page 1.
- K041357: Varelisa Gliadin Igg Antibodies, Sweden Diagnostics (Germany) GmbH (2004) Summary page 1.

## Indications for use
EliA Gliadin IgA is intended for the in vitro semi-quantitative measurement of IgA antibodies directed to gliadin in serum or plasma to aid in the diagnosis of celiac disease in conjunction with other laboratory and clinical findings. EliA Gliadin IgA uses the EliA IgA method on the instrument ImmunoCAP 100 and ImmunoCAP 250. EliA Gliadin IgG is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to gliadin in serum or plasma to aid in Zhe diagnosis of celiac disease in conjunction with other laboratory and clinical findings. EllA Gliadin IgG uses the EllA IgG method on the instruments lmmunoCAP 100 and ImmunoCAP 250. EllA Celiac Control is intended for laboratory use in monitoring the performance of in vitro measurement of antibodies to gliadin with ImmunoCAP 100 or 250 using the EIiA IgG or IgA method.

Source page: https://510kreport.com/device/K063775
Methodology: https://510kreport.com/methodology