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for the quantitative determination of high density lipoprotein (HDL) cholesterol in human serum or plasma. For in vitro diagnostic use. For the calibration of N-geneous HDL Cholesterol ass in serum or plasma. For in vitro diagnostic use.

The Genzyme N-geneous™ HDL Cholesterol Kit is an in vitro diagnostic product cleared (FDA Reference No. K962186) for use in the clinical laboratory for the quantitative determination of high density lipoprotein cholesterol in human serum or plasma. The first reagent contains a mixture of polymers and polyanions that bind to the surface of low-density lipoproteins (LDL), very low-density lipoproteins (VLDL) and chylomicrons. These complexed lipoproteins are stabilized, even in the presence of detergent which is added as part of the second reagent, together with the remaining components of a cholesterol reagent. HDL particles, on the other hand, are not stabilized by the polymers and polyanions and become solubilized by the detergent. Consequently, only the HDL cholesterol is subject to cholesterol measurement.

Here's a breakdown of the acceptance criteria and study information for the Genzyme N-geneous™ HDL Cholesterol Reagent Kit, based on the provided 510(k) Premarket Notification:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the NCEP (National Cholesterol Education Program) goals for precision. No explicit numerical targets for correlation coefficients are provided, but the reported values demonstrate substantial equivalence.

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The Genzyme N-geneous™ HDL Cholesterol Kit, is a two-reagent homogenous method for use in the direct quantitative determination of high density lipoprotein cholesterol (HDL-C) in human serum and plasma.

The Genzyme N-geneous™ HDL Cholesterol Kit, is a two-reagent homogenous method for use in the direct quantitative determination of high density lipoprotein cholesterol (HDL-C) in human serum and plasma. The first readent contains a mixture of polymers and polvanions that bind to the sufface of low-density lipoproteins (LDL), very low-density lipoproteins (VLDL) and chylomicrons. These complexed lipoproteins are stabilized, even in the presence of detergent which is added as part of the second reagent, together with cholesterol enzymes. HDL particles, on the other hand, are not stabilized by the polymers and polvanions and become solubilized by the detergent. Consequently, only the HDL cholesterol is subject to cholesterol measurement.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study used to prove the device meets these criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria in a dedicated section. However, based on the comparative performance studies, the implicit acceptance criteria for equivalence seem to be a high correlation coefficient and a regression equation demonstrating close agreement with the predicate methods. For precision, the acceptance criteria would be low %CV values, indicating good reproducibility.

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