LogoFDA 510(k) Search
K Number
K984163
Device Name
ANTI-TPO 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
K984167
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

This assay is intended for the in-vitro (TPO) present in serve as an aid in the design the in-yitro (TPO) present in serum, as an aid in the diagnosis of autoimune thyroid diseases.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for an "Anti-TPO Diagnostic Test Kit" and "Anti-TPO Enzyme Immunoassay Kit". This letter asserts substantial equivalence to a predicate device but does not contain the acceptance criteria or a study detailing device performance metrics (e.g., sensitivity, specificity, accuracy), sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot fulfill your request for information regarding:

  1. A table of acceptance criteria and the reported device performance
  2. Sample sizes used for the test set and the data provenance
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
  4. Adjudication method
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
  6. If a standalone performance (algorithm only) was done
  7. The type of ground truth used
  8. The sample size for the training set
  9. How the ground truth for the training set was established

This type of detailed performance data is typically found in the 510(k) submission itself (which is often much more extensive than the clearance letter) or in associated scientific publications, not in the FDA clearance letter provided. The clearance letter confirms that the FDA reviewed a submission and found the device to be substantially equivalent, implying that the submitted data met the necessary standards for clearance, but it does not present those data.

§ 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).