510(k) · Cleared
ClearedFidis Celiac
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomedical Diagnostics (Bmd) SA · MST Antibodies, Gliadin
Cleared on Mar 29, 2006 as substantially equivalent to K964986 (Inova Diagnostics, Inc., 1997) and 3 other predicates after a 114-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Mar 29, 2006
- Review
- 114 days
- Class
- Class II
- Product code
- MST
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K964986 (1997). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK964986 Quanta Lite Iga Gliadin ElisaInova Diagnostics, Inc. · 1997
- This deviceK053383 Fidis CeliacBiomedical Diagnostics (Bmd) SA · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K964986 | Quanta Lite Iga Gliadin Elisa | Inova Diagnostics, Inc. | 1997 | — |
| 0 (this device) | K053383 | Fidis Celiac | Biomedical Diagnostics (Bmd) SA | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2004 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K964986 | Quanta Lite Iga Gliadin ElisaSummary page 2…Irn _; biomedical diagnostics 3. Predicate Devices 510K Number Device Classification Name Manufacturer Name K964986 QuantaLiteTm IgA Gliadin INOVA Diagnostics, INC K982366… | 1997 |
| * | K982366 | Quanta Lite TTG (Tissue Transglutaminase) ElisaSummary page 2…ce Classification Name Manufacturer Name K964986 QuantaLiteTm IgA Gliadin INOVA Diagnostics, INC K982366 QuantaLiteTM IgA TTG INOVA Diagnostics, INC K041357 Varel… | 1998 |
| * | K041357 | Varelisa Gliadin Igg AntibodiesSummary page 2…ntaLiteTm IgA Gliadin INOVA Diagnostics, INC K982366 QuantaLiteTM IgA TTG INOVA Diagnostics, INC K041357 Varelisa® IgG Gliadin Sweden Diagnostics,… | 2004 |
| * | K041173 | Celikey Igg Itg Igg Antibodies, Model 17996Summary page 2…Varelisa® IgG Gliadin Sweden Diagnostics, GMIBH K041173 CelikeyO IgG TTG Sweden Diagnostics,… | 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 4 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™ CELIAC kit is a semi-quantitative homogeneous fluorescent-based microparticles immunoassay using flow cytometry readings. It is designed for the simultaneous detection of human isotype IgA or IgG antibodies directed against Gliadin and tissue Transglutaminase Enzyme
The presence of these antibodies can be used in conjunction with clinical findings to aid in diagnosis. The FIDIS™ CELIAC kit is to be used in serum only. The FIDIS™ CELIAC kits are to be used on FIDIS Analyzer, software and washer.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053383 · printed Nov 4, 2026
Cite this page
510(k) Report. “K053383: Fidis Celiac.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053383
Report an extraction error
Are you the manufacturer?
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