Product News: FDA Clears Randox Diabetes Quality Control

10 Apr 2014

FDA clearance gives US laboratories more QC choice in the marketplace

Randox today announced that the Food and Drug Administration has cleared the company’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 4 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, namely 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 5 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, as follows:

  • albumin
  • alpha–1–globulin
  • alpha–2–globulin
  • beta–globulin
  • gamma-globulin
  • chloride
  • glucose
  • immunoglobulin G
  • Lactate
  • Protein (Total)
  • Sodium

Randox’s US Director of Sales QC, John Schaefering said: “We are delighted to receive FDA clearance. It gives US laboratories more choice in the marketplace and will allow our US customers to benefit from improved accuracy in patient testing.”

All Randox controls are true third party controls, manufactured independently meaning they have not been optimized for use with any reagent, method or instrument. All assigned targets and ranges have been assigned using data from totally independent laboratories, resulting in genuinely independent, multi-method and multi-analyzer data.

For enhanced laboratory performance, all of Randox QC products can be used in conjunction with Acusera 24•7 Live Online, an interlaboratory data management and peer group reporting package designed to help monitor analytical performance, interpret QC results and, ultimately, to improve patient diagnosis through accurate and reliable patient test results.

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