FDA Grants 510(k) Clearance to Roche’s Tina-quant Molarity Assay
Roche has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Tina-quant Lipoprotein (a) Gen.2 Molarity assay, marking a milestone in cardiovascular diagnostics. This clearance makes it the first assay in the US to measure lipoprotein (a), or Lp(a), in nanomoles per litre (nmol/L). Lp(a) is a key biomarker in assessing … Continued