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Qbc Centrifugal Hematology Control

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

510(k) K954137 Product code JPK

Overview

The Qbc Centrifugal Hematology Control is an in vitro diagnostic reagent used as a quality control for centrifugal hematology systems. It is composed of mammalian erythrocytes, mammalian leukocytes, and simulated platelets in a plasma-like fluid with preservatives.

This device is intended for use in clinical laboratory settings and is tested in the same manner as patient samples. It has received FDA 510(k) clearance under K954137.

Summary written by AI from registry data, 21 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK954137 Date6 Oct 1995ClearedStatusActive

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
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  • Expiring
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United States — FDA 510(k) Active

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

Specification

510(k) · synced 22 Oct 2026

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 intended use of the QBC Centrifugal Hematology Control?

    This device is an in vitro diagnostic reagent designed to serve as a quality control for centrifugal hematology systems. It allows clinical laboratories to verify the performance of their systems by testing the control in the same manner as patient samples.

  • What is the composition of this hematology control?

    The control is formulated with mammalian erythrocytes, mammalian leukocytes, and simulated platelets suspended in a plasma-like fluid containing preservatives to ensure stability during use.

  • What is the regulatory status of this device?

    The QBC Centrifugal Hematology Control has received FDA 510(k) clearance under K954137. This indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K954137 24 fields · synced 22 Oct 2026