510(k) · Cleared
ClearedVarelisa Gliadin Iga Antibodies Model #19848/19896
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sweden Diagnostics (Germany) GmbH · MST Antibodies, Gliadin
Cleared on Jul 16, 2004 after a 57-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Jul 16, 2004
- Review
- 57 days
- Class
- Class II
- Product code
- MST
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK041354 Varelisa Gliadin Iga Antibodies Model #19848/19896Sweden Diagnostics (Germany) GmbH · 2004
- Descendant · cites it directly · 0 of its ownK063775 Elia Gliadin Iga, Igg and Celiac ControlPhadia US, Inc. · 2007
Most influential descendants
Showing 1 of 1 · See all- K063775Elia Gliadin Iga, Igg and Celiac ControlPhadia US, Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K041354 | Varelisa Gliadin Iga Antibodies Model #19848/19896 | Sweden Diagnostics (Germany) GmbH | 2004 | — |
| +1 | K063775 | Elia Gliadin Iga, Igg and Celiac Control | Phadia US, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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? (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 |
|---|---|---|---|
| * | — | INOVA QUANTA Lite™ Gliadin IgA Named without a submission number |
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 |
|---|---|---|---|
| K063775 | Elia Gliadin Iga, Igg and Celiac Control | 2007 | 0 |
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?
- Of its descendants, K063775 (Phadia US, Inc., 2007) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MST devicesMST Antibodies, Gliadin: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Varelisa Gliadin IgA Antibodies EIA kit is designed for the semiquantitative and
qualitative determination of gliadin (IgA) antibodies in serum or plasma to aid in the
diagnosis of certain gluten sensitive enteropathies such as celiac disease and dermatitis
herpetiformis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041354 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041354: Varelisa Gliadin Iga Antibodies Model #19848/19896.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041354
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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