# K061794: Fidis TM Thyro, Model MX002

- Pathway: 510(k) (Traditional)
- Applicant: Biomedical Diagnostics (Bmd) SA
- Decided: Nov 21, 2006 after 148 days
- Product code: JZO (System, Test, Thyroid Autoantibody)
- Device class: 2
- Regulation: 21 CFR 866.5870
- 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 K905486 (1991). 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)
- K905485: Immunowell Thyroglobulin Test, General Biometrics, Inc. (1991) Summary page 1.
- K905486: Immunowell Tpo (Microsome) Test, General Biometrics, Inc. (1991) Summary page 1.

## Indications for use
The FIDISTM THYRO kit is a semi-quantitative homogeneous fluorescent-based microparticles immunoassay using flow cytometry readings. It is designed for the detection of antibodies directed against thyroperoxydase (TPO) and thyroglobuline (TG). Clinical utility: The test system is used on serum samples as an aid in the diagnostic of auto-immune thyroid pathologies (Graves' disease and Hashimoto thryroiditis), in conjunction with clinical findings and other laboratory tests. The FIDISTM THYRO kit is to be used on FIDISTM Analyser, software and washer.

Source page: https://510kreport.com/device/K061794
Methodology: https://510kreport.com/methodology