510(k) · Cleared
ClearedImmulisa Anti-Human Tissue Transglutaminase (HU-TTG) Antibody Iga Elisa
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Immco Diagnostics, Inc. · MVM Autoantibodies, Endomysial (Tissue Transglutaminase)
Cleared on Dec 24, 2003 after a 126-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Dec 24, 2003
- Review
- 126 days
- Class
- Class II
- Product code
- MVM
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
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 MVM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MVM device
- #1 K200230 Aptiva Celiac Disease IgG Reagentscore 2.2 · 2 generations · no Class I recall
- #2 Held for the reportin 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?
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.
How does its category compare?
All MVM devicesMVM Autoantibodies, Endomysial (Tissue Transglutaminase): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MVM
2in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · MVM
275in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MVM
No recall names MVM since 2007.
Adverse event reports per year · MVM
1in 2024
MAUDE reports naming product code MVM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 3 | 98 | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 3 | 275 | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
An enzyme linked immunoassay (ELISA) for the detection and semi-quantitation of IgA antibodies to human tissue transglutaminase, as an aid in diagnosing patients with Gluten Sensitive Enteropathy (celiac Disease and Dematitis herpetiform-is)
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K032571 · printed Nov 4, 2026
Cite this page
510(k) Report. “K032571: Immulisa Anti-Human Tissue Transglutaminase (HU-TTG) Antibody Iga Elisa.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K032571
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026