Diazyme Laboratories, Inc. Announces FDA 510(k) Clearance for Lipoprotein(a) Molarity Assay (opens original article in a new tab)

Diazyme Laboratories received FDA 510(k) clearance for a new Lipoprotein(a) Molarity Assay that provides standardized measurement of Lp(a) levels in clinical settings.

• FDA granted 510(k) clearance for Diazyme's Lipoprotein(a) Molarity Assay
• Assay enables quantitative determination of Lp(a) levels in human serum and plasma
• Provides isoform-independent measurement in molar units for consistent cardiovascular risk assessment