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Dimension Vista Thyroid Stimulating Hormone Flex Reagent Cartridge

by Dade Behring, Inc. 510(k)

Active United States

510(k) K060090

Overview

The Dimension Vista Thyroid Stimulating Hormone Flex Reagent Cartridge is a device intended to measure thyroid stimulating hormone, also known as thyrotrophin and thyrotrophic hormone, in serum and plasma. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.

This device is supplied as a reagent cartridge and is for single-use in clinical laboratory settings. It is regulated as a Class II device with special controls under FDA 510(k) clearance K060090, product code JLW. The device is not indicated for MRI use and should be stored according to the manufacturer's specifications.

AI-generated from registry data, 24 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 NumberK060090 Date27 Feb 2006ClearedStatusActive

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

1 recall · FDA

    • Terminated Z-1884-2013 FDA Class II initiated 10 May 2013

    A rare variant of TSH, identified in a small cluster of patients, is not detected.

Specification

510(k)

510(k) Number
FDA Product Code
JLW
Device Class
Class II
Regulation
21 CFR Part 862.1690
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Dimension Vista Thyroid Stimulating Hormone Flex Reagent Cartridge used for?

    This device is used to measure thyroid stimulating hormone (TSH) in serum and plasma samples. These measurements help clinicians diagnose thyroid or pituitary disorders by assessing hormone levels produced by the anterior pituitary.

  • How is the Dimension Vista TSH Flex Reagent Cartridge supplied and is it reusable?

    The device is supplied as a reagent cartridge and is designed for single-use only in clinical laboratory settings. It should not be reused or repurposed after initial use to ensure accurate test results.

  • What are the storage requirements for this reagent cartridge?

    The cartridge should be stored according to the manufacturer's specifications. While the exact storage conditions aren't detailed in the provided information, users should follow the manufacturer's guidelines to maintain the integrity of the reagents.

  • What is the regulatory status of this device?

    This device is regulated as a Class II device with special controls under FDA 510(k) clearance K060090, product code JLW. It has been determined to be substantially equivalent to predicate devices for its intended use.