# K041002: Fidis Celiac

- Pathway: 510(k) (Traditional)
- Applicant: Biomedical Diagnostics S.A.
- Decided: Sep 24, 2004 after 158 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
Longest line of descent: 1 generation back to K981929 (1998). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981929: Bindazyme Antigliadin Igg/Iga Combi Kit, The Binding Site, Ltd. (1998) Summary page 3.
- K993612: Bindazyme Anti-Tissue Transglutaminase Iga Eia, The Binding Site, Ltd. (1999) Summary page 3.

## Indications for use
The FIDIS TM Celiac kit is a semi-quantitative homogeneous fluorescent-based microparticles immunoassay using flow cytometry readings. Celiac IgA is designed for the simultaneous detection of human IgA isotype antibodies directed against Gliadin and Tissue Transglutaminase Enzyme. Celiac IgG is designed for the detection of human IgG isotype antibodies directed against Gliadin. The presence of these antibodies can be used in conjunction with clinical findings to aid in the diagnosis of Celiac disease. The FIDISTM Celiac kit is to be used on serum only. FIDISTM Celiac kits are to be used on FIDIST Analyser, software and washer.

Source page: https://510kreport.com/device/K041002
Methodology: https://510kreport.com/methodology