FDA Grants 510(k) Clearance To Roche’s Tina-quant Molarity Assay

Roche receives FDA Clearance for blood test that assesses cardiovascular risk

Test is the first measuring lipoprotein (a) in nmol/L and will help assess cardiovascular disease risk in adults

FDA Grants 510(k) Clearance To Roche’s Tina-quant Molarity Assay

The test is conducted through a routine blood draw and measures the concentration of Lp(a) particles in the bloodstream. Credit: Nuttapong punna / Shutterstock. The US Food and Drug Administration (FDA) has granted 510(k) clearance to Roche’s Tina-quant Lipoprotein (a) Gen.2 Molarity assay. This is said to mark the first assay of its kind in the US to measure lipoprotein (a), also known as Lp(a), in nanomoles per litre (nmol/L). As per the Natio…

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FDA clears first blood test of its kind for Lp(a)

The new blood test from Roche Diagnostics measures Lp(a) in terms of nanomoles per liter (nmol/L) as opposed to milligrams per deciliter (mg/dL).

Roche Lp(a) Test Gets FDA Clearance for Cardiovascular Risk Assessment

Summary: Roche’s Tina-quant Lp(a) Gen.2 Molarity assay received FDA 510(k) clearance, supporting more precise cardiovascular risk assessment. Takeaways: First FDA-Cleared Lp(a) Test in nmol/L – Roche’s assay aligns with scientific consensus, providing more accurate Lp(a) measurements by counting particles rather than measuring mass. Improved Cardiovascular Risk Assessment – Elevated Lp(a) is a genetic risk factor for heart disease, and the Nati…

FDA Grants 510(k) Clearance to First Lp(a) Blood Test in Molar Units

Awarded to Roche, the Tina-quant® Lipoprotein (a) Gen.2 Molarity assay will be the first 510(k) cleared test measuring Lp(a) in nanomoles per liter (nmol/L).