# K053383: Fidis Celiac

- Pathway: 510(k) (Traditional)
- Applicant: Biomedical Diagnostics (Bmd) SA
- Decided: Mar 29, 2006 after 114 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 K964986 (1997). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964986: Quanta Lite Iga Gliadin Elisa, Inova Diagnostics, Inc. (1997) Summary page 2.
- K982366: Quanta Lite TTG (Tissue Transglutaminase) Elisa, Inova Diagnostics, Inc. (1998) Summary page 2.
- K041357: Varelisa Gliadin Igg Antibodies, Sweden Diagnostics (Germany) GmbH (2004) Summary page 2.
- K041173: Celikey Igg Itg Igg Antibodies, Model 17996, Sweden Diagnostics (Germany) GmbH (2004) Summary page 2.

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

Source page: https://510kreport.com/device/K053383
Methodology: https://510kreport.com/methodology