# K993250: The Aptus (Automated) Application of the Gliadin Igg Elisa Test System.

- Pathway: 510(k) (Traditional)
- Applicant: Zeus Scientific, Inc.
- Decided: Nov 12, 1999 after 45 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
The Gliadin IgG ELISA test system is intended for the qualitative and semi-quantitative detection of IgG-class antibodies to:gliadin in human serum. The test system is intended to be used as an:automated or manual aid in the diagnosis of gastrointestinal disorders, mainly Coeliac Disease. This test is for in vitro diagnostic use.

Source page: https://510kreport.com/device/K993250
Methodology: https://510kreport.com/methodology