# K964986: Quanta Lite Iga Gliadin Elisa

- Pathway: 510(k) (Traditional)
- Applicant: Inova Diagnostics, Inc.
- Decided: Jun 2, 1997 after 171 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.
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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K053383: Fidis Celiac (2006), 0 descendants of its own

## Indications for use
An Enzyme Linked Immunosorbant Assay (ELISA) for the semi-quantitative detection of IgA antibodies to gliadin in human serum. The detection of these antibodies is an aid in diagnosis of certain gluten sensitive enteropathies such as celiac disease and dermatitis herpetiformis.

Source page: https://510kreport.com/device/K964986
Methodology: https://510kreport.com/methodology