# K041357: Varelisa Gliadin Igg Antibodies

- Pathway: 510(k) (Traditional)
- Applicant: Sweden Diagnostics (Germany) GmbH
- Decided: Aug 2, 2004 after 74 days
- Product code: MST (Antibodies, Gliadin)
- Device class: 2
- Regulation: 21 CFR 866.5750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 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 Gliadin IgG: named in the summary without a submission number

## Most influential descendants
- K063775: Elia Gliadin Iga, Igg and Celiac Control (2007), 0 descendants of its own
- K053383: Fidis Celiac (2006), 0 descendants of its own

## Indications for use
The Varelisa Gliadin IgG Antibodies EIA kit is designed for the semiquantitative and qualitative determination of gliadin (IgG) antibodies in serum or plasma to aid in the diagnosis of certain gluten sensitive enteropathies such as celiac disease and dermatitis herpetiformis.

Source page: https://510kreport.com/device/K041357
Methodology: https://510kreport.com/methodology