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Haemonetics Nabs FDA 510(k) Clearance for Hemostasis Cartridge Assay

NEW YORK – Haemonetics announced on Thursday that its hemostasis cartridge assay has received 510(k) clearance from the US Food and Drug Administration.  

The TEG 6s hemostasis analyzer system Global Hemostasis-HN assay cartridge expands the firm's TEG 6s viscoelastic testing capabilities to serve fully heparinized patients in adult cardiovascular procedures and liver transplantation in both laboratory and point-of-care settings, the company said in a statement.  

Boston-based Haemonetics added that it plans to release the new cartridge in the coming months. 

The FDA clearance was supported by clinical data from a multisite trial that included 335 patients undergoing cardiac bypass surgeries, interventional cardiology procedures, or liver transplantations, the company said. Haemonetics also conducted an additional study with 164 healthy people to establish the normal reference ranges for the test cartridge.  

The TEG 6s system offers a complete picture of a patient's coagulation profile and includes software that allows for remote real-time viewing of results throughout the hospital, the firm said. 

"TEG testing provides critical information that can help physicians improve hemostasis management for their patients, especially in critical situations like open heart and liver transplant surgeries and major trauma," Jan Hartmann, Haemonetics' SVP and chief medical officer, said in a statement. "The Global Hemostasis-HN assay cartridge expands the benefits of TEG 6s system to patients on cardiopulmonary bypass or undergoing liver transplantation where heparin or endogenous heparinoids are present."