Qualigen Files a 510(k) Submission with the FDA for Its FastPack® IP SHBG Assay
Published: Oct 09, 2018
CARLSBAD, Calif., Oct. 9, 2018 /PRNewswire/ -- Qualigen, Inc., a privately-owned company that provides novel diagnostic and therapeutic technologies for the treatment of cancer and infectious diseases, today announced that the Company has submitted a 510(k) notification to the U.S. Food and Drug Administration (FDA or "the Agency") for its FastPack IP Sex Hormone Binding Globulin (SHBG) Immunoassay and has received acknowledgement from the Agency that the submission has been received. The purpose of the 510(k) notification is to allow for commercial use of the FastPack® IP SHBG Immunoassay for the quantitative determination of SHBG in human serum and plasma as an aid in the diagnosis of androgen disorders. "FastPack SHBG will add another important tool to our FastPack diagnostic line and represents our 10th FastPack assay," stated Michael S. Poirier, Chief Executive Officer of Qualigen. "When used in conjunction with our currently available FastPack Total Testosterone Assay, it will provide clinicians with a more complete picture of their patients' androgen status, particularly in the area of men's health and testosterone deficiency."
About Qualigen, Inc.
Qualigen, Inc. is a medical device company focused on the development, production and commercialization of innovative medical technologies, including its flagship FastPack® point-of-care immunoassay system and novel therapeutic technologies for treatment of cancers and infectious diseases. For more information, visit www.qualigeninc.com.
Disclaimer: The FastPack®IP SHBG Immunoassay is pending 510(k) clearance by the U.S. FDA. Not yet available for in vitro diagnostic use in the U.S.
© 2018 Qualigen. All rights reserved. Qualigen, the stylized logo, and FastPack are registered trademarks of Qualigen, Incorporated in the United States and other countries.
SOURCE Qualigen, Inc.