510(k) · Cleared
ClearedElia Celikey Igg Well, Model 14-5518-01, Elia Celiac Control, Model 83-1011-01
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Phadia US, Inc. · MVM Autoantibodies, Endomysial (Tissue Transglutaminase)
Cleared on Dec 26, 2006 as substantially equivalent to K041173 (Sweden Diagnostics (Germany) GmbH, 2004) after a 116-day review. Its family tree reaches back 1 generation to 2004. 1 later device descends from it.
- Decided
- Dec 26, 2006
- Review
- 116 days
- Class
- Class II
- Product code
- MVM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K041173 (2004). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK041173 Celikey Igg Itg Igg Antibodies, Model 17996Sweden Diagnostics (Germany) GmbH · 2004
- This deviceK062583 Elia Celikey Igg Well, Model 14-5518-01, Elia Celiac Control, Model…Phadia US, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK181871 EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA…Phadia AB · 2019
Most influential descendants
Showing 1 of 1 · See all- K181871EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG…Phadia AB · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K041173 | Celikey Igg Itg Igg Antibodies, Model 17996 | Sweden Diagnostics (Germany) GmbH | 2004 | — |
| 0 (this device) | K062583 | Elia Celikey Igg Well, Model 14-5518-01, Elia Celiac Control, Model 83-1011-01 | Phadia US, Inc. | 2006 | — |
| +1 | K181871 | EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP… | Phadia AB | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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? (1)
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 |
|---|---|---|---|
| * | K041173 | Celikey Igg Itg Igg Antibodies, Model 17996Summary page 1…II 866.5660 Substantial Equivalence to Celikey IgG Tissue Transglutaminase (human, recombinant) IgG Antibody Assay 510(k) number: K041173 CONFIDENTIAL AND PROPRIETARY EliA TM Celikey IgG - New Device 510(k) Submission Secti… | 2004 |
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 |
|---|---|---|---|
| K181871 | EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG… | 2019 | 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?
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?
EIiA Celikey IgG is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to tissue transglutaminase (tTG) in human serum and plasma. EliA Celikey IgG is based on recombinant human tissue transglutaminase as the antigen and is useful as an aid in the clinical diagnosis of patients with celiac disease. EIiA Celikey IgG uses the EliA IgG method on the instrument InmmunoCAP 100 and ImmunoCAP 250.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062583 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062583: Elia Celikey Igg Well, Model 14-5518-01, Elia Celiac Control, Model 83-1011-01.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062583
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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