Medical Device Regulation in the EU Digital Liver ADAPT navify® Algorithms, ADAPT INS_8060 by Evidencio 10 673 044 001 10673044001 ADAPT 3.x ADAPT 3.x 08720938015298 Electronic Services Not Available Not Available ADAPT is an algorithm intended to combine age, diabetes status, Elecsys® PRO-C3 concentration and platelet count to assess the severity of hepatic fibrosis in patients showing evidence or signs of metabolic dysfunction-associated steatotic liver disease (MASLD). The ADAPT result must be interpreted in conjunction with other methods and in accordance with standard clinical management guidelines.ADAPT is medical device software that automates the calculation of the formula. It requires quantitative and qualitative inputs to provide a semi-quantitative output.ADAPT is not intended to replace clinical decision-making; it can only provide information to the healthcare professional on the estimation of the severity of liver fibrosis. The healthcare professional can use this information to support clinical decision-making.Additional remarks on the intended useThe Pro-C3 concentrations and the platelet count have to be determined using a serum/plasma sample and the whole blood sample, respectively, from the same blood draw/sample collection. en

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