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K Number
K981522
Device Name
AIA-PACK TGAB ASSAY
Manufacturer
TOSOH MEDICS, INC.
Date Cleared
1998-10-08

(163 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

AIA-PACK TgAb is intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of anti-thyroglobulin antibodies (TgAb) in human serum on specific TOSOH AIA System analyzers. Measurements obtained by this device aid in the diagnosis of autoimmune thyroid disorders, such as Graves' disease and Hashimoto's disease.

Device Description

AIA-PACK TgAb Assay

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information needed to describe the acceptance criteria and the study that proves the device meets them, as requested. The document is an FDA 510(k) clearance letter for the AIA-PACK TGAb Assay, which primarily states that the device is substantially equivalent to a legally marketed predicate device.

It does not include:

  1. A table of acceptance criteria and reported device performance.
  2. Information on sample sizes, data provenance, or details about the test set.
  3. The number or qualifications of experts or adjudication methods for ground truth.
  4. Details about multi-reader multi-case (MRMC) comparative effectiveness studies.
  5. Information on standalone algorithm performance.
  6. The type of ground truth used.
  7. Sample size for the training set or how its ground truth was established.

The document essentially grants market clearance based on substantial equivalence, but it does not delve into the specifics of the performance study that led to this determination.

§ 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).