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Foe the quantitative determination of HDL-Cholesterol in scrum. For IN VITRO diagnostic use.

The procedure for HDL-Cholesterol precipitation in this formulation is a modification of the Burnstein and Samaille (2) method and uses phosphotungstate and magnesium ions to precipitate the LDL and VLDL fractions.

The provided text is a 510(k) premarket notification approval letter for a medical device called "HDL Uni-Paks (PTA)." This document does not contain acceptance criteria or a detailed study description that proves the device meets specific performance metrics.

Instead, this letter from the FDA confirms that the device is "substantially equivalent" to a legally marketed predicate device, allowing it to be marketed. The letter mentions that the manufacturer's 510(k) submission includes information that the FDA reviewed, but the submission itself is not provided here.

Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, ground truth method, etc.) from the given text.

The text only states:

• Device Name: HDL Uni-Paks (PTA), Catalogue Number 215-51
• Intended Use: For the quantitative determination of HDL-Cholesterol in serum. For IN VITRO diagnostic use.
• Mechanism: Uses phosphotungstate and magnesium ions to selectively precipitate VLDL and LDL fractions, leaving HDL in the supernatant for cholesterol concentration assay. It's a modification of the Burnstein and Samaille method.
• Regulatory Class: I
• Product Code: LBR
• 510(k) Number: K980770

To answer your questions, one would need to refer to the actual 510(k) submission document (K980770) from Diagnostic Chemicals Limited, which would contain the performance data and the studies conducted to demonstrate substantial equivalence to the predicate device.

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