# K093459: Elia Gliadin DP Iga Immunoassay and Elia Gliadin DP Igg Immunoassay, Models 14-5538-01, 14-5539-01

- Pathway: 510(k) (Traditional)
- Applicant: Phadia US, Inc.
- Decided: Aug 13, 2010 after 280 days
- Product code: MST (Antibodies, Gliadin)
- Device class: 2
- Regulation: 21 CFR 866.5750
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K052143 (2005). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052143: Quanta Lite Gliadin Iga II, Inova Diagnostics, Inc. (2005)
- K052142: Quanta Lite Gliadin Igg II, Inova Diagnostics, Inc. (2005)

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

## Recalls of this device
- May 1, 2023 · Class II · Z-2041-2023: Higher reported results when running EliA GliadinDP IgG Well on the instruments Phadia 2500EE compared to running EliA GliadinDP IgG Well on Phadia 250 instrument
- May 1, 2023 · Class II · Z-2040-2023: Higher reported results when running EliA GliadinDP IgG Well on the instruments Phadia 2500EE compared to running EliA GliadinDP IgG Well on Phadia 250 instrument

## Indications for use
EliA Gliadin DP IgG is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to gliadin in human serum and plasma (heparin, EDTA, citrate) to aid in the diagnosis of celiac disease in conjunction with other laboratory and clinical findings. EliA Gliadin DP IgG uses the EliA IgG method on the instruments Phadia® 100 and Phadia® 250. EliA Gliadin DP IgA is intended for the in vitro semi-quantitative measurement of IgA antibodies directed to gliadin in human serum and plasma (heparin, EDTA, citrate) to aid in the diagnosis of celiac disease in conjunction with other laboratory and clinical findings. EliA Gliadin DP IgA uses the EliA IgA method on the instruments Phadia® 100 and Phadia® 250.

Source page: https://510kreport.com/device/K093459
Methodology: https://510kreport.com/methodology