# K063818: Quanta Plex Celiac Iga Profile

- Pathway: 510(k) (Traditional)
- Applicant: Inova Diagnostics, Inc.
- Decided: Jun 20, 2007 after 180 days
- Product code: MVM (Autoantibodies, Endomysial(Tissue Transglutaminase))
- Device class: 2
- Regulation: 21 CFR 866.5660
- 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
The QUANTA PlexTM Celiac IgA Profile is a fluorescent immunoassay for the semi-quantitative detection of IgA anti-human tissue transglutaminase (htTG) and anti-deamidated gliadin peptide (DGP) antibodies, and the detection of an insufficient amount of IgA, in human serum. The presence of these antibodies in conjunction with other laboratory and clinical findings is an aid in the diagnosis of the gluten sensitive enteropathy celiac disease. Insufficient IgA indicates that there is not enough IgA to allow detection of IgA anti-htTG or anti-DGP.

Source page: https://510kreport.com/device/K063818
Methodology: https://510kreport.com/methodology