FDA clears Randox diabetes quality control

April 11, 2014

The U.S. Food and Drug Administration (FDA) has cleared Randox’s HbA1c quality control, a product used to ensure accuracy in diagnosis and the ongoing monitoring of diabetes. Randox’s Acusera HbA1c is a lyophilized control, enhancing stability and longevity, with assayed values provided for HPLC and a wide range of clinical chemistry analyzers. It is a 100% human whole blood control, which helps minimize matrix effects, reducing lot-to-lot variations between batches. When reconstituted the control remains stable for four weeks at +2 – 8°c. The control is available in levels 1 and 2, and a calibrator is also available.

The FDA has also cleared for use two Randox clinical chemistry controls: Aldolase calibrator and controls, and Ammonia Ethanol control. Acusera Aldolase calibrator and controls can be used when testing for liver damage as well as skeletal muscle diseases such as muscular dystrophy. Randox Aldolase control is available in levels 2 and 3 and is lyophilized, with a reconstituted stability of five days at +2 – 8°c. Randox Ammonia Ethanol control is liquid ready-to-use, with an open vial stability of 30 days at +2 – 8°c, and comes in levels 1, 2 and 3.

Randox has also received FDA clearance for its Immunology CSF control. This is a multi-analyte cerebrospinal fluid control, which is suitable for use on most clinical analyzers providing method-specific target values and ranges for 11 analytes: albumin, alpha-1-globulin, alpha-2-globulin, beta-globulin, gamma-globulin, chloride, glucose, immunoglobulin G, lactate, protein (total), and sodium.

Randox’s U.S. Director of Sales QC John Schaefering says, “We are delighted to receive FDA clearance. It gives U.S. laboratories more choice in the marketplace and will allow our U.S. customers to benefit from improved accuracy in patient testing.” Learn more about the Diabetes Quality Controls from Randox.

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