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The TRab CT Assay Kit is for the quantitative or qualitative determination of thyroid stimulating hormone receptor antibody in human serum. The TRab CT Assay kit is useful as an aid in differential diagnosis of Graves' disease.

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This looks like a 510(k) clearance letter from the FDA for a diagnostic kit, not an AI/ML device. Therefore, the requested information about acceptance criteria, study design, expert involvement, and AI-specific metrics (like MRMC studies or human-in-the-loop performance) is not applicable in the context of this document.

The document discusses the regulatory pathway (substantial equivalence to a predicate device) for a TSH Receptor Antibody (TRAb) Coated Tube (CT) Assay Kit.

Here's what can be extracted from the provided text, focusing on what is available:

• Device Name: KRONUS TSH Receptor Antibody (TRAb) Coated Tube (CT) Assay Kit
• Indications for Use:
  • Quantitative or qualitative determination of thyroid stimulating hormone receptor antibody in human serum.
  • Useful as an aid in the differential diagnosis of Graves' disease.

To provide the detailed information requested (acceptance criteria, study design, sample sizes, ground truth, etc.), I would need a different type of document, such as the premarket notification (510(k) submission) itself, which typically includes performance data and study summaries. This letter merely grants clearance based on the review of that submission.

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