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For the calibration of test systems for the measurement of HDL and LDL Cholesterol in human serum or plasma.

The Boehringer Mannheim c.f.a.s. - HDL/LDL-C plus calibrator consists of lyophilized human serum with added HDL-Cholesterol and LDL-Cholesterol.

The provided text is a 510(k) Summary for a medical device, specifically a calibrator used in diagnostic tests for HDL and LDL cholesterol. This type of document is for regulatory clearance and does not typically include detailed study results, acceptance criteria, or performance metrics in the way a clinical study report would.

Therefore, the document does not contain the information requested in points 1-9 regarding acceptance criteria and a study proving the device meets those criteria.

The 510(k) Summary focuses on demonstrating "substantial equivalence" to a predicate device, not on presenting novel performance data from a clinical trial with acceptance criteria. It states:

• "The Boehringer Mannheim Direct LDL-Cholesterol test is substantially equivalent to other products in commercial distribution intended for similar use."
• "The intended use of this BM calibrator and the predicate devices is the same..."

For this type of device (a calibrator), the "performance" demonstrated for regulatory clearance would likely involve analytical studies confirming its accuracy, precision, and stability as a calibrator, ensuring it produces expected values when used with compatible test systems. However, these specific details are not present in the provided text.

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