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K Number
K033977
Device Name
ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE TPO/TG IGG TEST SYSTEM
Manufacturer
ZEUS SCIENTIFIC, INC.
Date Cleared
2004-03-22

(90 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 Zeus Scientific, Inc. AtheNA Multi-Lyte™ TPO/Tg Test System is for the qualitative and quantitative detection of IgG autoantibodies to human thyroid peroxidase and/or human thyroglobulin in human serum. The results of this serological test together with other clinical findings may aid in the diagnosis of thyroid diseases. This test is for in vitro diagnostic use.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA regarding the AtheNA Multi-Lyte™ TPO/Tg Test System. It confirms substantial equivalence to a predicate device but does not contain any information regarding acceptance criteria, device performance metrics, or details of a study that proves the device meets specific criteria.

Therefore, I cannot fulfill your request for:

  1. A table of acceptance criteria and the reported device performance: This information is not present.
  2. Sample size used for the test set and the data provenance: This information is not present.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present.
  4. Adjudication method for the test set: This information is not present.
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: This information is not present.
  6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This information is not present.
  7. The type of ground truth used: This information is not present.
  8. The sample size for the training set: This information is not present.
  9. How the ground truth for the training set was established: This information is not present.

The document is a regulatory approval letter based on "substantial equivalence" to existing devices, not a detailed study report. To find the information you're looking for, you would typically need to consult the full 510(k) submission or a separate clinical study report from the manufacturer.

§ 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).