510(k) · Cleared
ClearedQuanta Lite H-TTG (Human Tissue Transglutaminase) Iga Elisa
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inova Diagnostics, Inc. · MVM Autoantibodies, Endomysial (Tissue Transglutaminase)
Cleared on Jul 9, 2001 after a 49-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Jul 9, 2001
- Review
- 49 days
- Class
- Class II
- Product code
- MVM
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK011566 Quanta Lite H-TTG (Human Tissue Transglutaminase) Iga ElisaInova Diagnostics, Inc. · 2001
- Descendant · cites it directly · 0 of its ownK140691 IG_Plex Celiac DGP PanelSqi Diagnostics Systems, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK130053 Bioplex 2200 Celiac Iga and Igg Kits on the Bioplex 2200 System…Bio-Rad Laboratories, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK073145 Quanta Lite H-TTG ScreenInova Diagnostics, Inc. · 2008
Most influential descendants
Showing 3 of 3 · See all- K140691IG_Plex Celiac DGP PanelSqi Diagnostics Systems, Inc. · 2014 · cites it directly0descendants
- K130053Bioplex 2200 Celiac Iga and Igg Kits on the Bioplex 2200 System, Bioplex 2200 Celiac Iga…Bio-Rad Laboratories, Inc. · 2013 · cites it directly0descendants
- K073145Quanta Lite H-TTG ScreenInova Diagnostics, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011566 | Quanta Lite H-TTG (Human Tissue Transglutaminase) Iga Elisa | Inova Diagnostics, Inc. | 2001 | — |
| +1 | K140691 | IG_Plex Celiac DGP Panel | Sqi Diagnostics Systems, Inc. | 2014 | — |
| +1 | K130053 | Bioplex 2200 Celiac Iga and Igg Kits on the Bioplex 2200 System, Bioplex 2200… | Bio-Rad Laboratories, Inc. | 2013 | — |
| +1 | K073145 | Quanta Lite H-TTG Screen | Inova Diagnostics, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 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 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? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K140691 (Sqi Diagnostics Systems, Inc., 2014) has gone furthest, with 0 descendants of its own.
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 Immunosorbant Assay (ELISA) for the semi-quantitative detection of IgA antibodies to tissue transglutaminase (endomysium) in human serum. Detection of these antibodies is an aid in diagnosis of certain gluten sensitive enteropathies such as celiac disease and dermatitis herpetiformis.
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/K011566 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011566: Quanta Lite H-TTG (Human Tissue Transglutaminase) Iga Elisa.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011566
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026