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HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K192842

by Eurotrol B.V.

Identifiers

510(k) Number
K192842 FDA 510(k)
FDA Product Code
GGM FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 864.8625 FDA 510(k)
Regulation Number
864.8625 FDA 510(k)
Advisory Committee
Hematology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The HemoTrol Duo Low, HemoTrol Duo Normal, and HemoTrol Duo High are liquid quality control materials designed for hematology analyzers. These controls are used to monitor and verify the accuracy, precision, and reliability of hemoglobin measurements in clinical laboratory settings, ensuring consistent test performance.

Each HemoTrol Duo variant is supplied as a liquid control, intended for single-use in automated hematology systems. The products are classified under the IVDD (In Vitro Diagnostic Medical Device Directive) and hold FDA 510(k) clearance as substantially equivalent devices, regulated under classification GGM (General/Other Hematology Controls). They are stored refrigerated and must be used within specified stability periods as indicated on the labeling.

Frequently asked questions

What are the HemoTrol Duo Low, Normal, and High controls specifically used for in a clinical lab?

These controls are designed to monitor and verify the accuracy, precision, and reliability of hemoglobin measurements on automated hematology analyzers. By running the HemoTrol Duo variants—Low, Normal, and High—clinicians can ensure consistent test performance and maintain confidence in their hemoglobin results.

Are the HemoTrol Duo controls meant for single-use or repeated use in a hematology analyzer?

The HemoTrol Duo controls are explicitly intended for single-use in automated hematology systems. Each vial is formulated for one measurement cycle to maintain accuracy and prevent contamination.

How should the HemoTrol Duo controls be stored, and what is their shelf life?

These controls must be stored refrigerated (typically between 2°C and 8°C) to preserve stability. The exact shelf life and expiration period are clearly labeled on each package, so always follow the instructions provided to ensure valid results.

What regulatory pathways have the HemoTrol Duo controls undergone, and how are they classified?

The HemoTrol Duo variants hold FDA 510(k) clearance as substantially equivalent devices under classification GGM (General/Other Hematology Controls). They also comply with the In Vitro Diagnostic Medical Device Directive (IVDD), confirming their regulatory compliance for use in clinical hematology.

This description and any FAQs above were generated automatically from registry data 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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

IVDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Eurotrol B.V.

Sources (2)

  • FDA 510(k) K192842 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026