BENICIA, Calif., May 31 /PRNewswire/ -- AcroMetrix Corporation, the leading provider of quality controls for clinical diagnostic and blood testing laboratories, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration for the VeriSure® Pro HBV DNA External Quality Control. This control is for use on Chiron’s Procleix® Ultrio(TM) Assay for the detection of HBV DNA using nucleic acid amplification. The clearance from the FDA allows the VeriSure® Pro HBV DNA External Quality Control (EQC) to be the first control for the Procleix® Ultrio(TM) HBV Assay to be marketed and sold in the United States “For In vitro diagnostic use”.
“We are pleased to receive clearance from the FDA,” said Michael J. Eck, CEO, AcroMetrix. “The VeriSure® Pro HBV DNA EQC adds another valuable product to our comprehensive line of controls for the blood screening laboratory.”
AcroMetrix is the only Chiron approved provider of controls for the Chiron Procleix® and Ultrio(TM) assays. The VeriSure® Pro line of External Quality Controls is intended to provide a means of estimating accuracy and detecting systematic deviations of nucleic acid test procedures for the qualitative determination of HIV-1 RNA, HBV DNA, HCV RNA, and WNV RNA. The HIV-1, HCV, and WNV assays are the only fully approved Procleix® assays for use in the screening of blood and plasma samples in the United States.
About AcroMetrix
AcroMetrix, with facilities in Benicia, California and Alkmaar, the Netherlands, provides a comprehensive line of molecular and serological diagnostic quality control products that assist laboratories in meeting current government regulations regarding quality. AcroMetrix maintains this leadership role by consistently developing innovative standards, external run controls, and validation kits for molecular and serological testing in blood screening and clinical diagnostic laboratories. For more information on AcroMetrix please visit the company web site at http://www.acrometrix.com.
Source: AcroMetrix Corporation
