Direct HDL-C Calibrator KHD-C01/C02 (K-ASSAY)

For In Vitro Diagnostic Use

Introduction

The K-ASSAY Direct HDL-Cholesterol Calibrator is intended to be used for the calibration of the K-ASSAY Direct HDL-Cholesterol liquid chemistry assay for quantitating Direct HDL-Cholesterol in serum samples.

Set composition

Calibrators should be used as specified in the K-ASSAY Direct HDL-Cholesterol liquid chemistry assay package insert.

KHD-C01 Direct HDL-Cholesterol Calibrator (Large)	4 × 1 ml
KHD-C02 Direct HDL-Cholesterol Calibrator	1 × 1 ml

Calibrator Values

Concentration of lyophilized serum, reconstituted with 1 ml of purified water(undiluted):

HDL-Cholesterol Value (mg/dl)

62.0

The values for the K-ASSAY Direct HDL-Cholesterol Calibrator are continually being revised through ongoing quality assurance. As a result, the expected values may change from lot to lot. Please refer to the package insert for each lot for the exact calibrator values.

The established HDL-Cholesterol value for the K-ASSAY Direct HDL-Cholesterol Calibrator is traceable to National Institute of Standards Standard Reference Material (1951a). The value was assigned on the basis of ultracentrifugation and quantification of the remaining Cholesterol. The procedures used to assign value to this calibrator materials meet the requirements of the "HDL Cholesterol Method Evaluation Protocol for Manufactures" of the U.S. National Reference System for Cholesterol, CRMLN (Cholesterol Reference Method Laboratory Network), August 1995.