Brahms Diagnostica DYNOTEST Anti-TPO

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K992791 ↗

FDA Product Code

JZO

Device Class

Class II

Regulation

21 CFR Part 866.5870

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Brahms Diagnostica Lumitest Trak Human

  Class II

  FDA 510(k) K033454 Active Cleared 22 Mar 2004

• Brahms Diagnostica Dynotest Anti-Tg

  Class II

  FDA 510(k) K992790 Active Cleared 12 Nov 1999

• Brahms Diagnostica Lumitest Anti-Tg

  Class II

  FDA 510(k) K000286 Active Cleared 17 Mar 2000

• Brahms Diagnostica Dynotest Tg-Plus

  Class II

  FDA 510(k) K021057 Active Cleared 17 Sep 2002

• Brahms Diagnostica Lumitest Anti-Tpo

  Class II

  FDA 510(k) K000287 Active Cleared 17 Mar 2000

• What is the Brahms DYNOTEST Anti-TPO used for?

  The DYNOTEST Anti-TPO is designed to detect anti-thyroid peroxidase (anti-TPO) antibodies in human serum using a competitive radioimmunoassay (RIA). This test helps clinicians evaluate autoimmune thyroid disorders, such as Hashimoto’s thyroiditis and Graves’ disease, by quantifying circulating anti-TPO antibodies. The assay measures antibody levels indirectly by competing patient antibodies with radioactively labeled thyroid peroxidase for binding to monoclonal antibodies in a coated tube.

• How is the Brahms DYNOTEST Anti-TPO supplied and what are its handling requirements?

  The DYNOTEST Anti-TPO is supplied as a single-use kit, meaning each test requires a new kit. No additional sterilization is required beyond the manufacturer’s controls, as it is intended for in vitro diagnostic use in clinical laboratories. Handling follows standard protocols for radioactive materials, as the assay employs a radiolabeled component. It is not intended for use outside regulated laboratory settings.

• Is the Brahms DYNOTEST Anti-TPO sterile, and how should it be stored?

  The DYNOTEST Anti-TPO is not intended to be sterilized beyond the manufacturer’s internal controls, as it is a single-use diagnostic kit. Storage should adhere to standard laboratory protocols for radioactive materials, including proper shielding and containment. The kit should be stored in a secure, controlled environment to prevent contamination or degradation of the radiolabeled components. Always follow the manufacturer’s instructions for optimal performance.

• Can the Brahms DYNOTEST Anti-TPO be reused, and what are the available sizes or models?

  The DYNOTEST Anti-TPO is explicitly designed for single-use only, and reuse is not recommended or supported by the manufacturer. This device does not come in multiple sizes or models; it is a standardized test kit for detecting anti-TPO antibodies in human serum. The assay format and components are consistent across all supplied kits to ensure reliable and reproducible results.

• What regulatory approvals apply to the Brahms DYNOTEST Anti-TPO, and what are its safety considerations?

  The DYNOTEST Anti-TPO holds FDA 510(k) clearance under the reference number K992791, classified as a Class II device under special controls (product code JZO). It is authorized under 21 CFR 866.5870 and is intended exclusively for professional medical use in clinical laboratories. Safety considerations include adherence to standard radioactive material handling protocols, as the assay involves radiolabeled components. There are no MRI safety considerations, and the device must be used in compliance with FDA regulations and laboratory guidelines.