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Vista Free Thyroxine Assay

by Syva Co. 510(k)

Active United States

510(k) K923572

Overview

The Vista Free Thyroxine Assay is a radioimmunoassay device intended to measure free (not protein bound) thyroxine (thyroid hormone) in serum or plasma. It is used to assess the amount of thyroxine hormone available to cells, which may reflect the clinical metabolic status of thyroxine.

The device is supplied as a test system for in vitro diagnostic use. It received FDA 510(k) clearance (K923572) on November 16, 1992, and is classified as a Class II device under product code CEC with special controls. The assay is used in clinical chemistry settings for the diagnosis and treatment of thyroid-related conditions based on measured free thyroxine levels.

AI-generated from registry data, 28 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK923572 Date16 Nov 1992ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
CEC
Device Class
Class II
Regulation
21 CFR Part 862.1695
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Vista Free Thyroxine Assay used for?

    The Vista Free Thyroxine Assay is intended to measure free (not protein bound) thyroxine in serum or plasma. It assesses the amount of thyroxine hormone available to cells, which may reflect the clinical metabolic status of thyroxine, and is used in clinical chemistry settings for the diagnosis and treatment of thyroid-related conditions based on measured free thyroxine levels.

  • How is the Vista Free Thyroxine Assay supplied and what type of device is it?

    The device is supplied as a test system for in vitro diagnostic use. It is a radioimmunoassay device designed to measure free thyroxine levels in serum or plasma specimens, intended for use in clinical laboratories to support thyroid function evaluation.

  • Is the Vista Free Thyroxine Assay a single-use or reusable device?

    As a radioimmunoassay test system, the Vista Free Thyroxine Assay consists of reagents and components intended for single test runs. While the data does not explicitly state single-use or reusable classification, radioimmunoassay kits are typically designed for single-use per test due to reagent stability and contamination risks, and the device is intended for in vitro diagnostic use as a test system.