Hemotec Hepcon HMS Coagulation System & Access

• • Terminated Z-1070-2010 FDA Unclassified (pre-2012) ·initiated 14 Dec 2009

  Recently the US Food and Drug Administration (FDA) issued an alert, communicating a change in the United States Pharmacopeia (USP) monograph for heparin, introducing a new USP reference standard that will in effect, change potency, and harmonize the USP unit dose with the WHO International Standard (IU) unit dose. Users of the Medtronic Hemostasis Management System (HMS Plus) must be aware o

510(k) Number

K894317 ↗

FDA Product Code

JOX

Device Class

Class II

Regulation

21 CFR Part 864.5680

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Hepcol System B-10 & B-10-P

  Class II

  FDA 510(k) K830665 Active Cleared 8 Jun 1983

• Hepcon/System Rc-10

  Class II

  FDA 510(k) K800161 Active Cleared 19 Mar 1980

• Hemotec Citrated Whole Blood Coagulation Controls

  Class II

  FDA 510(k) K854376 Active Cleared 4 Dec 1985

• Hemotec Act I System

  Class II

  FDA 510(k) K843459 Active Cleared 12 Dec 1984

• Additional Hemotec Hepcon/Sys B-10 Coagulation Car

  Class II

  FDA 510(k) K853789 Active Cleared 4 Oct 1985

• Clottrac(Tm) Ibex Heparinase Hr Act Cart./Control

  Class II

  FDA 510(k) K902081 Active Cleared 3 Jul 1990

See all devices from Hemotec, Inc. →

• What is the Hemotec Hepcon HMS Coagulation System used for?

  The Hemotec Hepcon HMS Coagulation System is designed to monitor coagulation parameters, specifically measuring heparin-induced clotting times. This automated analyzer aids clinicians in managing anticoagulation therapy by providing real-time assessments of clotting dynamics, ensuring accurate and timely diagnostic support in hematology laboratories and clinical environments.

• Is the Hemotec Hepcon HMS Coagulation System reusable or single-use?

  The Hemotec Hepcon HMS Coagulation System itself is a reusable device. However, it is supplied with single-use accessories, which are intended for one-time use to maintain sterility and reliability during coagulation testing. This design ensures both cost-effectiveness for the core system and safety for clinical procedures.

• What storage and handling protocols should be followed for this device?

  The Hemotec Hepcon HMS Coagulation System must be stored and handled according to standard aseptic protocols for reusable medical equipment. Since it is a reusable system, it requires proper calibration and maintenance to ensure accurate coagulation testing. Single-use accessories should be stored in their original packaging until use, following manufacturer guidelines to preserve sterility.

• Does the Hemotec Hepcon HMS Coagulation System have any MRI safety restrictions?

  No specific MRI safety restrictions are noted for the Hemotec Hepcon HMS Coagulation System. However, standard precautions for reusable medical devices should be followed, and users should consult the manufacturer’s instructions for any additional safety considerations in environments where MRI procedures are conducted.

• How is the regulatory status of this device confirmed?

  The Hemotec Hepcon HMS Coagulation System holds FDA clearance under the 510(k) submission K894317, classified as a Class II medical device. Its regulatory status was reviewed and confirmed by the Hematology (HE) Advisory Committee, ensuring compliance with FDA regulations for automated analyzers used in coagulation testing. The device falls under FDA regulation 864.5680.