Diazyme Laboratories, Inc. Announces FDA 501(k) Clearance for MGUS for Kappa and Lambda Free Light Chain Assays
14th Jan 2026
SAN DIEGO, CA - January 14, 2026 - Diazyme Laboratories, Inc. announces receiving 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the evaluation of monoclonal gammopathy of undetermined significance (MGUS) for Diazyme’s Kappa and Lambda Free Light Chain Assays.
“FDA 510(k) clearance of added indication to our free light chain kappa and lambda assays demonstrates Diazyme’s commitment to delivering reliable, clinically meaningful diagnostics for plasma cell disorders,” said Dr. Chong Yuan, Managing Director of Diazyme Laboratories, Inc. “This clearance enables clinical laboratories and physicians to use Diazyme’s assays for measurement of Kappa and Lambda FLC in in the diagnosis and monitoring of multiple myeloma (MM) and aid in the evaluation of monoclonal gammopathy of undetermined significance (MGUS) in conjunction with other laboratory and clinical findings.”
About Diazyme
Diazyme Laboratories, Inc. is located in Poway, California. Diazyme uses its proprietary enzyme and immunoassay technologies to develop invitro diagnostic tests that are run on automated chemistry analyzers and chemiluminescence instruments in user-friendly formats. Diazyme is a cGMP and ISO 13485 certified medical device manufacturer. Information regarding Diazyme's technology and products can be found on its website at www.diazyme.com
For Further Information Contact:
Regulatory
Dr. Abhijit Datta, Ph.D
Abhijit.Datta@diazyme.com
Sales
Emile Dergham
610-694-0435
Emile.Dergham@Diazyme.com