# K964985: Quanta Lite Igg Gliadin Elisa

- Pathway: 510(k) (Traditional)
- Applicant: Inova Diagnostics, Inc.
- Decided: May 30, 1997 after 168 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
An Enzyme Linked Immunosorbant Assay (ELISA) for the semi-quantitative detection of IgG antibodies to gliadin in human serum. 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/K964985
Methodology: https://510kreport.com/methodology