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This product is to be used as a quantitative control in the determination of cholesterol content of high density lipoproteins (HDL) and low density lipoproteins (LDL) using the REP agarose electrophoresis system.

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This is a 510(k) clearance letter for a control solution, explicitly stating that it's for "quantitative control in the determination of cholesterol content of high density lipoproteins (HDL) and low density lipoproteins (LDL) using the REP agarose electrophoresis system."

The letter does not contain the kind of detailed study information (acceptance criteria, performance data, sample sizes, expert qualifications, etc.) that would typically be found in a Premarket Approval (PMA) application or a more detailed submission for a diagnostic device.

Therefore, I cannot provide the requested information from the provided text.

Here's why:

• Device Type: This is a control solution, used to verify the performance of a cholesterol measurement system, not the measurement system itself. The FDA clearance is based on its substantial equivalence as a laboratory control, not on its diagnostic accuracy in patients.
• 510(k) vs. PMA: A 510(k) submission primarily demonstrates "substantial equivalence" to a predicate device. While some data is required, it generally doesn't involve the extensive clinical trial data and detailed performance analysis (including specific acceptance criteria, ground truth establishment, expert adjudication, etc.) that would be necessary for a de novo classification or a PMA. The detailed performance studies would typically be conducted for the measurement system (the REP agarose electrophoresis system), not necessarily for the control itself beyond its stability and correct value assignment.

To get the information you're asking for, you would need documentation related to the performance studies of the REP agarose electrophoresis system, not the REP Cholesterol Profile Control-II.

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