# K052142: Quanta Lite Gliadin Igg II

- Pathway: 510(k) (Traditional)
- Applicant: Inova Diagnostics, Inc.
- Decided: Oct 4, 2005 after 57 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.
7 later devices descend from it; 4 cite it directly.
0 of 8 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
- K113863: Quanta Flash DGP Iga, Quanta Flash DGP Igg, Quanta Flash DGP Iga Calibrators, Quanta Flash DGP Igg Calibrators (2012), 2 descendants of its own
- K093459: Elia Gliadin DP Iga Immunoassay and Elia Gliadin DP Igg Immunoassay, Models 14-5538-01, 14-5539-01 (2010), 1 descendant of its own
- K200230: Aptiva Celiac Disease IgG Reagent (2021), 0 descendants of its own
- K193604: Aptiva Celiac Disease IgA Reagent (2021), 0 descendants of its own
- K181871: EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG Immunoassay (2019), 0 descendants of its own

## Indications for use
The QUANTA Lite Gliadin IgG II is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of gliadin IgG antibodies in human serum. The presence of gliadin antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of celiac disease.

Source page: https://510kreport.com/device/K052142
Methodology: https://510kreport.com/methodology