# K041173: Celikey Igg Itg Igg Antibodies, Model 17996

- Pathway: 510(k) (Traditional)
- Applicant: Sweden Diagnostics (Germany) GmbH
- Decided: Aug 2, 2004 after 89 days
- Product code: MVM (Autoantibodies, Endomysial(Tissue Transglutaminase))
- Device class: 2
- Regulation: 21 CFR 866.5660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) INOVA QUANTA Lite h-tTG (Human tissue transglutaminase): named in the summary without a submission number

## Most influential descendants
- K062583: Elia Celikey Igg Well, Model 14-5518-01, Elia Celiac Control, Model 83-1011-01 (2006), 1 descendant of its own
- K181871: EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG Immunoassay (2019), 0 descendants of its own
- K053383: Fidis Celiac (2006), 0 descendants of its own

## Indications for use
Celikey IgG is intended for the semiquantitative and qualitative measurement of anti-tissue transglutaminase (tTG) IgG antibodies in human serum and plasma. Celikey IgG is based on recombinant human tissue transglutaminase as antigen and is useful as an aid in the clinical diagnosis of patients with celiac disease.

Source page: https://510kreport.com/device/K041173
Methodology: https://510kreport.com/methodology