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Access Hypersensitive hTSH Assay

by Beckman Coulter, Inc.

510(k) K023093

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK023093 Date25 Nov 2002ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

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

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Access Hypersensitive hTSH Assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of human thyroid-stimulating hormone (thyrotropin, hTSH) levels in human serum and plasma. It is designed for use with Beckman Coulter Access Immunoassay Systems.

The assay is supplied as a reagent kit for in vitro diagnostic use. It received FDA 510(k) clearance (K023093) and is classified as a Class II device under regulation number 862.1690, with product code JLW and medical specialty designation in Clinical Chemistry.

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Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Access Hypersensitive hTSH Assay used for?

    It is used for the quantitative determination of human thyroid-stimulating hormone (hTSH) levels in human serum and plasma, aiding in the assessment of thyroid function as an in vitro diagnostic tool.

  • How is the Access Hypersensitive hTSH Assay supplied and what system is it designed for?

    The assay is supplied as a reagent kit for in vitro diagnostic use and is specifically designed for use with Beckman Coulter Access Immunoassay Systems, utilizing paramagnetic particle chemiluminescent technology.

  • Is the Access Hypersensitive hTSH Assay a single-use or reusable reagent kit?

    As a reagent kit for in vitro diagnostic use, it is intended for single-use testing runs; reagents are consumed during the assay process and not reused to ensure test integrity and prevent cross-contamination.

  • What regulatory pathway was used for the Access Hypersensitive hTSH Assay and what is its classification?

    The device received FDA 510(k) clearance under submission K023093 and is classified as a Class II medical device under regulation 862.1690 with product code JLW.

  • What sample types are compatible with the Access Hypersensitive hTSH Assay?

    The assay is designed for use with human serum and plasma samples, as specified in its intended use for quantitative hTSH determination in these matrices.