510(k) · Cleared
ClearedFidis Celiac
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomedical Diagnostics S.A. · MST Antibodies, Gliadin
Cleared on Sep 24, 2004 as substantially equivalent to K981929 (The Binding Site, Ltd., 1998) and 1 other predicate after a 158-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Sep 24, 2004
- Review
- 158 days
- Class
- Class II
- Product code
- MST
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K981929 (1998). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK981929 Bindazyme Antigliadin Igg/Iga Combi KitThe Binding Site, Ltd. · 1998
- This deviceK041002 Fidis CeliacBiomedical Diagnostics S.A. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K981929 | Bindazyme Antigliadin Igg/Iga Combi Kit | The Binding Site, Ltd. | 1998 | — |
| 0 (this device) | K041002 | Fidis Celiac | Biomedical Diagnostics S.A. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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 |
|---|---|---|---|
| * | K981929 | Bindazyme Antigliadin Igg/Iga Combi KitSummary page 3…' TM ELISA Human Anti Gliadin IgG Kit BiNDAZYME TM ELISA Human Anti Gliadin IgA Kit BINDAZYME TM ELISA Human Anti Tissue Transglutaminase IgA Kit Predicate K number(s): K981929, K981929 and K993612 Comparison with predicate: Item Predicate devices… | 1998 |
| * | K993612 | Bindazyme Anti-Tissue Transglutaminase Iga EiaSummary page 3…Gliadin IgG Kit BiNDAZYME TM ELISA Human Anti Gliadin IgA Kit BINDAZYME TM ELISA Human Anti Tissue Transglutaminase IgA Kit Predicate K number(s): K981929, K981929 and K993612 Comparison with predicate: Item Predicate devices Current dev… | 1999 |
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.
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 FIDIS TM Celiac kit is a semi-quantitative homogeneous fluorescent-based microparticles immunoassay using flow cytometry readings.
Celiac IgA is designed for the simultaneous detection of human IgA isotype antibodies directed against Gliadin and Tissue Transglutaminase Enzyme.
Celiac IgG is designed for the detection of human IgG isotype antibodies directed against Gliadin.
The presence of these antibodies can be used in conjunction with clinical findings to aid in the diagnosis of Celiac disease.
The FIDISTM Celiac kit is to be used on serum only.
FIDISTM Celiac kits are to be used on FIDIST Analyser, software and washer.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041002 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041002: Fidis Celiac.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041002
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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