# K041174: Celikey TTG (Human, Recombinant) Iga Antibodies Model #18148/18196

- Pathway: 510(k) (Traditional)
- Applicant: Sweden Diagnostics (Germany) GmbH
- Decided: Jul 19, 2004 after 75 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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 T tTG: named in the summary without a submission number

## Most influential descendants
- K062787: Elia Celikey Iga Well, Model 14-5517-01; Elia Celiac Control, Model 83-1011-01 (2006), 0 descendants of its own

## Indications for use
Celikey is intended for the serniquantitative and qualitative measurement of anti-tissue transglutaminase (tTG) IgA antibodies in human serum and plasma. Celikey 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/K041174
Methodology: https://510kreport.com/methodology