510(k) · Cleared
ClearedElia Celikey Iga Well, Model 14-5517-01; 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 29, 2006 as substantially equivalent to K041174 (Sweden Diagnostics (Germany) GmbH, 2004) after a 102-day review. Its family tree reaches back 1 generation to 2004.
- Decided
- Dec 29, 2006
- Review
- 102 days
- Class
- Class II
- Product code
- MVM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K041174 (2004). No later device cites it as a predicate yet.
- Root · 1 generation backK041174 Celikey TTG (Human, Recombinant) Iga Antibodies Model #18148/18196Sweden Diagnostics (Germany) GmbH · 2004
- This deviceK062787 Elia Celikey Iga Well, Model 14-5517-01; Elia Celiac Control, Model…Phadia US, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K041174 | Celikey TTG (Human, Recombinant) Iga Antibodies Model #18148/18196 | Sweden Diagnostics (Germany) GmbH | 2004 | — |
| 0 (this device) | K062787 | Elia Celikey Iga Well, Model 14-5517-01; Elia Celiac Control, Model 83-1011-01 | Phadia US, Inc. | 2006 | — |
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 |
|---|---|---|---|
| * | K041174 | Celikey TTG (Human, Recombinant) Iga Antibodies Model #18148/18196Summary page 1…tial Equivalence to Celikey Tissue Transglutaminase (human, recombinant) IgA Aifiboody Assay 510(k) number: K041174 CONFIDENTIAL AND PROPRI ET Page 62 EliA TM Celikey IgA - N… | 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?
- Its one ancestor has no 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?
EliA Celiac Control is intended for laboratory use in monitoring the performance of in vitro measurement of antibodies to tissue transglutaminase (tTG) with ImmunoCAP 100 or 250 using the EliA IgG or IgA method. EliA Celikey IgA Immunoassay is intended for the in vitro semi-quantitative measurement of IgA antibodies directed to tissue transglutaminase (tTG) in human serum and plasma (EDTA, citrate). EliA Celikey IgA Immunoassay is based on recombinant…
Read the full statement (114 words)
EliA Celiac Control is intended for laboratory use in monitoring the performance of in vitro measurement of antibodies to tissue transglutaminase (tTG) with ImmunoCAP 100 or 250 using the EliA IgG or IgA method.
EliA Celikey IgA Immunoassay is intended for the in vitro semi-quantitative measurement of IgA antibodies directed to tissue transglutaminase (tTG) in human serum and plasma (EDTA, citrate). EliA Celikey IgA Immunoassay is based on recombinant human tissue transglutaminase as antigen and is useful as an aid in the clinical diagnosis of patients with celiac disease, in conjunction with other laboratory and clinical findings. EliA Celikey IgA Immunoassay uses the EliA IgA method on the instrument ImmunoCAP 100 and ImmunoCAP 250.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062787 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062787: Elia Celikey Iga Well, Model 14-5517-01; 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/K062787
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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