Fidis Tm Thyro, Model MX002
by Biomedical Diagnostics (Bmd) SA
510(k) K061794
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK061794 | Date21 Nov 2006 | StatusActive |
Recalls
No FDA recalls found in the data synced 5 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- JZO
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.5870
- Advisory Committee
- Immunology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The FIDIS THYRO, Model MX002 is a System, Test, Thyroid Autoantibody device designed for the qualitative detection of thyroid autoantibodies in serum samples. It aids in the diagnostic evaluation of autoimmune thyroid disorders, including Graves’ disease and Hashimoto thyroiditis, by identifying circulating antibodies such as thyrotropin receptor antibodies (TRAb) and thyroid peroxidase antibodies (TPOAb). The system operates as an immunoassay-based test, providing results through a fully automated workflow on the FIDIS Analyser platform.
This device is supplied as a single-use kit for use in clinical laboratories, requiring compatibility with the FIDIS Analyser and associated software and washer. It is classified under FDA regulation 866.5870 and holds a 510(k) clearance (K061794) with a Substantially Equivalent (SESE) determination. The test is intended for in vitro diagnostic use only and must be performed in accordance with manufacturer instructions to ensure accurate results. No MRI safety or sterility specifications are noted in the regulatory data.
Other devices from Biomedical Diagnostics (Bmd) SA
Questions
AI-generated answers, 1 Oct 2026
What is the FIDIS THYRO MX002 used for?
The FIDIS THYRO MX002 is an immunoassay-based test designed for the qualitative detection of thyroid autoantibodies in serum samples. It aids in diagnosing autoimmune thyroid disorders, such as Graves’ disease and Hashimoto thyroiditis, by identifying circulating antibodies like thyrotropin receptor antibodies (TRAb) and thyroid peroxidase antibodies (TPOAb). This helps clinicians evaluate patients suspected of having these conditions.
How is the FIDIS THYRO MX002 supplied and used?
The FIDIS THYRO MX002 is supplied as a single-use kit intended for use in clinical laboratories. It requires compatibility with the FIDIS Analyser platform, including its associated software and washer. The test must be performed strictly according to the manufacturer’s instructions to ensure accurate and reliable results.
Is the FIDIS THYRO MX002 sterile?
The regulatory data for the FIDIS THYRO MX002 does not specify any sterility requirements or claims. As a single-use diagnostic test, it should be handled in accordance with standard clinical laboratory practices to maintain sample integrity and prevent contamination.
What regulatory approval does the FIDIS THYRO MX002 hold?
The FIDIS THYRO MX002 holds an FDA 510(k) clearance with the determination of Substantially Equivalent (SESE) under the classification 866.5870. It was reviewed by the FDA’s Immunology (IM) Advisory Committee and is intended for in vitro diagnostic use only.
Does the FIDIS THYRO MX002 require any specific storage conditions?
The regulatory data does not provide explicit storage instructions for the FIDIS THYRO MX002. However, as a single-use diagnostic kit, it should be stored in a clean, dry environment, protected from extreme temperatures and direct light, following general laboratory protocols for immunoassay reagents. Always refer to the manufacturer’s instructions for precise storage guidelines.