510(k) · Cleared
ClearedEU-TTG Iga and EU-TTG Igg
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Grifols USA, Inc. · MVM Autoantibodies, Endomysial (Tissue Transglutaminase)
Cleared on Mar 7, 2011 as substantially equivalent to K010625 (Scimedx Corp., 2001) and 1 other predicate after a 153-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Mar 7, 2011
- Review
- 153 days
- Class
- Class II
- Product code
- MVM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K010625 (2001). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK010625 Eurospital EU-TTG Iga UmanaScimedx Corp. · 2001
- This deviceK102964 EU-TTG Iga and EU-TTG IggGrifols USA, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010625 | Eurospital EU-TTG Iga Umana | Scimedx Corp. | 2001 | — |
| 0 (this device) | K102964 | EU-TTG Iga and EU-TTG Igg | Grifols USA, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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 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? (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 |
|---|---|---|---|
| * | K010625 | Eurospital EU-TTG Iga UmanaSummary page 1…ode: MVM, Autoantilbodies, Endomysial (Tissue Transglutaminase) Panel: Immunology (82) 6. Predicate Devices: Eu-tTG® IgA umana (K010625), predicate for Eu-tTG® IgA Aeskulisa rTG G (K042644), predicate for Eu-tTG® IgG… | 2001 |
| * | K042644 | Aeskulisa TTG a and Aeskulisa TTG GSummary page 1…lutaminase) Panel: Immunology (82) 6. Predicate Devices: Eu-tTG® IgA umana (K010625), predicate for Eu-tTG® IgA Aeskulisa rTG G (K042644), predicate for Eu-tTG® IgG Page… | 2005 |
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?
- 1 of the 2 ancestors has a recall of any class.
How does its category compare?
All MVM devicesMVM Autoantibodies, Endomysial (Tissue Transglutaminase): FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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?
The Eu-tTG® IgA is an in vitro diagnostic enzyme immunoassay for the semi-quantitative detection of IgA specific antibodies directed against tissue transglutamninase (tTG) in human serum. It is an aid in the diagnosis of celiac disease and should be used in conjunction with other serological tests and clinical findings.
The Eu-tTG® IgG is an in vitro diagnostic enzyme immunoassay for the semi-quantitative detection of IgG specific antibodies directed against tissue transglutaminase (tTG) in human serum. It is an aid in the diagnosis of celiac disease and should be used in conjunction with other serological tests and clinical findings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102964 · printed Nov 4, 2026
Cite this page
510(k) Report. “K102964: EU-TTG Iga and EU-TTG Igg.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K102964
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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