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ESR Control-HC Hematology Erythrocyte Sedimentation

by R&D Systems, Inc. 510(k)

Active United States

510(k) K972170

Overview

ESR Control-HC Hematology Erythrocyte Sedimentation is a bi-level hematology control designed to document and monitor values obtained from HiChem Mini-VES and VES-Matic automated ESR analyzers. It is used to ensure the accuracy and reliability of erythrocyte sedimentation rate (ESR) testing in clinical laboratory settings.

The device is supplied as a quality control material for use in hematology analyzers. It is intended for in vitro diagnostic use and is regulated under FDA 510(k) clearance K972170, with a device class of II and product code JPK. The device is not described as sterile, single-use, or reusable in the provided data, and no MRI safety, storage conditions, or size specifications are included.

AI-generated from registry data, 22 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK972170 Date24 Jul 1997ClearedStatusActive

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: none on record (FDA, checked 22 Oct 2026)

Specification

510(k)

510(k) Number
FDA Product Code
JPK
Device Class
Class II
Regulation
21 CFR Part 864.8625
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the ESR Control-HC used for?

    The ESR Control-HC is a bi-level hematology control designed to document and monitor values obtained from HiChem Mini-VES and VES-Matic automated ESR analyzers, ensuring the accuracy and reliability of erythrocyte sedimentation rate testing in clinical laboratory settings.

  • How is the ESR Control-HC supplied and intended for use?

    The device is supplied as a quality control material for use in hematology analyzers and is intended for in vitro diagnostic use to verify the performance of automated ESR analyzers.

  • Is the ESR Control-HC sterile, single-use, or reusable?

    The provided data does not describe the ESR Control-HC as sterile, single-use, or reusable; no information on sterility or reuse is included in the device specifications.