510(k) · Cleared
ClearedGliadin Iga and Gliadin Lga
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Grifols USA, LLC · MST Antibodies, Gliadin
Cleared on Dec 14, 2012 as substantially equivalent to K052439 (Aesku Diagnostics, 2006) after a 394-day review. Its family tree reaches back 1 generation to 2006.
- Decided
- Dec 14, 2012
- Review
- 394 days
- Class
- Class II
- Product code
- MST
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K052439 (2006). No later device cites it as a predicate yet.
- Root · 1 generation backK052439 Aeskulisa Glia a and Aeskulisa Glia GAesku Diagnostics · 2006
- This deviceK113377 Gliadin Iga and Gliadin LgaGrifols USA, LLC · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K052439 | Aeskulisa Glia a and Aeskulisa Glia G | Aesku Diagnostics | 2006 | — |
| 0 (this device) | K113377 | Gliadin Iga and Gliadin Lga | Grifols USA, LLC | 2012 | — |
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? (1)
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 |
|---|---|---|---|
| * | K052439 | Aeskulisa Glia a and Aeskulisa Glia GSummary page 1…osorbent (RAST) immunological test system Classification: * Class 2 Product Code: MST, Antibodies, Gliadin Panel: Immunology 6. Predicate Devices: Aeskulisa® Glia A (K052439), predicate for a-Gliatest® IgA and a-GliaPep® IgA Aeskulisa® Glia G (K052439), predicate for a-Gliatest® IgG and a-GliaPep® 1gG… | 2006 |
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?
- Its one ancestor has no recall.
How does its category compare?
All MST devicesMST Antibodies, Gliadin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
The a-Gliatest® IgA is intended for the semi-quantitative determination of IgA antibodies directed against gliadin in human serum. The assay is an aid in the diagnosis of celiac disease and should be used in conjunction with other serological tests and clinical findings. The a-Gliatest® IgG is intended for the semi-quantitative determination of IgG antibodies directed against gliadin in human serum. The assay is an aid in the diagnosis of celiac disease…
Read the full statement (172 words)
The a-Gliatest® IgA is intended for the semi-quantitative determination of IgA antibodies directed against gliadin in human serum. The assay is an aid in the diagnosis of celiac disease and should be used in conjunction with other serological tests and clinical findings.
The a-Gliatest® IgG is intended for the semi-quantitative determination of IgG antibodies directed against gliadin in human serum. The assay is an aid in the diagnosis of celiac disease and should be used in conjunction with other serological tests and clinical findings.
The a-GliaPep® IgA is intended for the semi-quantitative determination of IgA antibodies directed against deamidated gliadin peptide in human serum. The assay is an aid in the diagnosis of celiac disease and should be used in conjunction with other serological tests and clinical findings.
The a-GliaPep® IgG is intended for the semi-quantitative determination of IgG antibodies directed against deamidated gliadin peptide in human serum. The assay is an aid in the diagnosis of celiac disease and should be used in conjunction with other serological tests and clinical findings.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K113377 · printed Nov 5, 2026
Cite this page
510(k) Report. “K113377: Gliadin Iga and Gliadin Lga.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K113377
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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