510(k) · Cleared
ClearedBindazyme Antigliadin Igg/Iga Combi Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Binding Site, Ltd. · MST Antibodies, Gliadin
Cleared on Sep 3, 1998 after a 118-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Sep 3, 1998
- Review
- 118 days
- Class
- Class II
- Product code
- MST
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK981929 Bindazyme Antigliadin Igg/Iga Combi KitThe Binding Site, Ltd. · 1998
- Descendant · cites it directly · 0 of its ownK041002 Fidis CeliacBiomedical Diagnostics S.A. · 2004
Most influential descendants
Showing 1 of 1 · See all- K041002Fidis CeliacBiomedical Diagnostics S.A. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981929 | Bindazyme Antigliadin Igg/Iga Combi Kit | The Binding Site, Ltd. | 1998 | — |
| +1 | K041002 | Fidis Celiac | Biomedical Diagnostics S.A. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 |
|---|---|---|---|
| K041002 | Fidis Celiac | 2004 | 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, K041002 (Biomedical Diagnostics S.A., 2004) 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?
This assay is designed for the in-vitro measurement of specific IgA antibodies present in human serum against gliadin, as an 2id in the diagnosis of celiac disease.
When sold in combination these assays are designed for the in-vitro measurement of specific Ig9G and IgA antibodies present in human serum against gliadin, as an aid in the diagnosis of celiac disease.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981929 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981929: Bindazyme Antigliadin Igg/Iga Combi Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981929
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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