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GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (…

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K202101

by Accriva Diagnostics, Inc.

Identifiers

510(k) Number
K202101 FDA 510(k)
FDA Product Code
JPA FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 864.5425 FDA 510(k)
Regulation Number
864.5425 FDA 510(k)
Advisory Committee
Hematology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The GEM Hemochron 100 System is a multipurpose in vitro coagulation analyzer designed for activated clotting time (ACT) testing. It measures whole blood clotting dynamics, including standard ACT, low-range ACT (ACT-LR), and ACT with heparin neutralization (ACT+), to support perioperative and critical care monitoring of anticoagulation status.

This system is intended for single-use in clinical laboratory and point-of-care settings, with controls available for quality assurance. It operates under FDA 510(k) clearance and IVDR compliance, featuring non-magnetic components for MRI safety. The device includes disposable test cartridges and controls, requiring no special storage conditions beyond standard laboratory practices.

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

IVDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Accriva Diagnostics, Inc.

Sources (2)

  • FDA 510(k) K202101 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 19, 2026