510(k) · Cleared
ClearedElia Gliadin Iga, Igg and Celiac Control
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 Mar 14, 2007 as substantially equivalent to K041354 (Sweden Diagnostics (Germany) GmbH, 2004) and 1 other predicate after an 83-day review. Its family tree reaches back 1 generation to 2004.
- Decided
- Mar 14, 2007
- Review
- 83 days
- Class
- Class II
- Product code
- MST
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K041354 (2004). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK041354 Varelisa Gliadin Iga Antibodies Model #19848/19896Sweden Diagnostics (Germany) GmbH · 2004
- This deviceK063775 Elia Gliadin Iga, Igg and Celiac ControlPhadia US, Inc. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K041354 | Varelisa Gliadin Iga Antibodies Model #19848/19896 | Sweden Diagnostics (Germany) GmbH | 2004 | — |
| 0 (this device) | K063775 | Elia Gliadin Iga, Igg and Celiac Control | Phadia US, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K041354 | Varelisa Gliadin Iga Antibodies Model #19848/19896Summary page 1…ntrol JJY I 862.1660 Substantial Equivalence to Varelisa Gliadin IgA Antibodies 510(k) number: K041354 Varelisa Gliadin IgG Antibodies 510(k) number: K041357 CONFIDENTIAL AND PROPRIET… | 2004 |
| * | K041357 | Varelisa Gliadin Igg AntibodiesSummary page 1…Equivalence to Varelisa Gliadin IgA Antibodies 510(k) number: K041354 Varelisa Gliadin IgG Antibodies 510(k) number: K041357 CONFIDENTIAL AND PROPRIET Page 112 EllATM Gfiadin IgA/IgG -… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
How does its category compare?
All MST devicesMST Antibodies, Gliadin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 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…
Read the full statement (138 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063775 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063775: Elia Gliadin Iga, Igg and Celiac Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063775
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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