510(k) · Cleared
Recalled · Class II · 2023Elia Gliadin DP Iga Immunoassay and Elia Gliadin DP Igg Immunoassay, Models 14-5538-01, 14-5539-01
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Phadia US, Inc. · MST Antibodies, Gliadin
Cleared on Aug 13, 2010 as substantially equivalent to K052143 (Inova Diagnostics, Inc., 2005) and 1 other predicate after a 280-day review. Its family tree reaches back 1 generation to 2005. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Aug 13, 2010
- Review
- 280 days
- Class
- Class II
- Product code
- MST
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 1 generation to K052143 (2005). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK052143 Quanta Lite Gliadin Iga IIInova Diagnostics, Inc. · 2005
- This deviceK093459 Elia Gliadin DP Iga Immunoassay and Elia Gliadin DP Igg Immunoassay…Phadia US, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK181871 EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA…Phadia AB · 2019
Most influential descendants
Showing 1 of 1 · See all- K181871EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG…Phadia AB · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K052143 | Quanta Lite Gliadin Iga II | Inova Diagnostics, Inc. | 2005 | — |
| 0 (this device) | K093459 | Elia Gliadin DP Iga Immunoassay and Elia Gliadin DP Igg Immunoassay, Models… | Phadia US, Inc. | 2010 | — |
| +1 | K181871 | EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP… | Phadia AB | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MST? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181871 | EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG… | 2019 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 1, 2023 | Class II | Z-2041-2023 | Under Investigation by firm | 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 | Under Investigation by firm | 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 |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All MST devicesMST Antibodies, Gliadin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · MST
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MST
Too few MST 510(k)s in any year since 2007 to give a median.
Recalls per year · MST
1in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MST
No MAUDE report names MST since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 1 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (118 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093459 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093459: Elia Gliadin DP Iga Immunoassay and Elia Gliadin DP Igg Immunoassay, Models 14-5538-01, 14-5539-01.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093459
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026