# K062708: Quanta Lite Celiac DGP Screen

- Pathway: 510(k) (Traditional)
- Applicant: Inova Diagnostics, Inc.
- Decided: Dec 13, 2006 after 93 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. The FDA summary names no predicate by number.

## Indications for use
QUANTA Lite TM Celiac DGP Screen is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of IgA and IgG antibodies to synthetic, deamidated gliadin-derived peptides in human serum. The presence of these deamidated peptide antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of both IgA sufficient and IgA deficient celiac disease as well as dermatitis herpetiformis.

Source page: https://510kreport.com/device/K062708
Methodology: https://510kreport.com/methodology