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K Number
K984165
Device Name
ANTI-THYROGLOBULIN EIA DIAGNOSTIC TEST KIT
Manufacturer
THE BINDING SITE, LTD.
Date Cleared
1999-02-02

(74 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

This assay is intended for the in-yitro measurement of specific IgG antibodies against thyroglobulin present in serum, as an aid in the diagnosis of autoimmune thyroid diseases.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for an "Anti-Thyroglobulin Diagnostic Test Kit." It primarily focuses on the regulatory approval process and does not contain information about the specific acceptance criteria, study design, or performance metrics of the device itself.

Therefore, I cannot extract the requested information regarding:

  • A table of acceptance criteria and reported device performance.
  • Sample size and data provenance for the test set.
  • Number and qualifications of experts for ground truth establishment.
  • Adjudication method.
  • MRMC comparative effectiveness study results.
  • Standalone performance.
  • Type of ground truth used.
  • Sample size for the training set.
  • How ground truth for the training set was established.

The document only states that the device is an "Anti-Thyroglobulin Enzyme Immunoassay Kit" intended for "in-vitro measurement of specific IgG antibodies against thyroglobulin present in serum, as an aid in the diagnosis of autoimmune thyroid diseases." It confirms that the FDA reviewed the 510(k) notification and determined the device to be substantially equivalent to legally marketed predicate devices, allowing it to be marketed.

§ 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).