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K Number
K032134
Device Name
TSH RECEPTOR ANTIBODY (TRAB) COATED TUBE (CT) ASSAY KIT
Manufacturer
KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.
Date Cleared
2003-09-10

(61 days)

Product Code
JZO
Regulation Number
866.5870
Type
Traditional
Panel
IM
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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.

Device Description

Not Found

AI/ML Overview

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.

§ 866.5870 Thyroid autoantibody immunological test system.

(a)
Identification. A thyroid autoantibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the thyroid autoantibodies (antibodies produced against the body's own tissues). Measurement of thyroid autoantibodies may aid in the diagnosis of certain thyroid disorders, such as Hashimoto's disease (chronic lymphocytic thyroiditis), nontoxic goiter (enlargement of thyroid gland), Grave's disease (enlargement of the thyroid gland with protrusion of the eyeballs), and cancer of the thyroid.(b)
Classification. Class II (performance standards).