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For the in vitro quantitative determination of the Lipoprotein(a) in human serum, Liheparin plasma and EDTA plasma on T60 instruments.

Measurement of low-density lipoprotein in serum may aid in the diagnosis of disorders of lipid (fat) metabolism and help to identify specific populations at risk from cardiovascular diseases

Lipoprotein(a) Calibrator is used as a calibrator for quantification of Lipoprotein(a) in serum and plasma by immunoturbidimetry with T60 instruments using methods defined by Thermo Electron Oy

For in vitro diagnostic use on T60 instrument. Lipoprotein(a) Control is intended to be used as an assayed control serum to monitor precision of Lipoprotein(a) test defined by Thermo Electron Oy

For in vitro diagnostic use on T60 instrument. Lipoprotein(a) Control High is intended to be used as an assayed control serum to monitor precision of Lipoprotein(a) test defined by Thermo Electron Oy.

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The provided text is a 510(k) premarket notification decision letter from the FDA to Thermo Electron Oy for their Lipoprotein(a) test system. This document grants market clearance for the device but does not contain the detailed study information or acceptance criteria requested.

Therefore, I cannot extract the specific information required to answer your questions about acceptance criteria, device performance, study details (sample sizes, provenance, expert qualifications, adjudication, MRMC, standalone), or ground truth establishment. This type of information is typically found within the actual 510(k) submission document, which is not provided here.

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