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K Number
K991610
Device Name
ZEUS SCIENTIFIC INC., TPO IGG ELISA TEST SYSTEM.
Manufacturer
ZEUS SCIENTIFIC, INC.
Date Cleared
1999-06-25

(46 days)

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

The Zeus Scientific, Inc. TPO (thyroid peroxidase) IgG ELISA Test System is an enzyme linked immunosorbent assay (ELISA) for the qualitative and semiquantitative detection of IgG autoantibodies to human thyroid peroxidase 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

This document is a 510(k) clearance letter from the FDA for a diagnostic device. It does not contain information about the acceptance criteria or a study proving the device meets those criteria. Therefore, I cannot address most of your request.

Here's what can be inferred from the provided text:

  • Device Name: Zeus Scientific, Inc., TPO IgG ELISA Test System
  • Indications for Use: "The Zeus Scientific, Inc. TPO (thyroid peroxidase) IgG ELISA Test System is an enzyme linked immunosorbent assay (ELISA) for the qualitative and semiquantitative detection of IgG autoantibodies to human thyroid peroxidase 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."

The letter states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices, meaning it performs similarly to other devices already on the market. However, it does not provide the specific performance metrics, study design, or expert qualifications that would be detailed in a study report.

To answer your questions, the actual 510(k) submission document, which would include the study data and acceptance criteria, would be needed. This letter is simply the FDA's decision based on 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).