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FOR IMMEDIATE RELEASE Borrelia burgdorferi B31 FDA Clearance AnnouncementIVD Lyme BlotAugust 2005 -- Viramed receives clearance for the sale and distribution of the Borrelia burgdorferi Western blot in the United States. Borrelia burgdorferi B31 ViraBlot Information The FDA notified Viramed that the 510k documentation for the IgG and IgM Western blots had been accepted and approved. The clearance process requires submission of performance data to demonstrate sensitivity and specificity of the device. Panels of sera collected from clinically defined Lyme disease patients, endemic and non-endemic sera from healthy individuals, and other disease state sera are included. In addition, performance data for the CAP proficiency and routine laboratory testing is submitted. Once the data had been submitted and accepted, the "instructions for use" went through a lengthy process of changes to comply with FDA regulations. In retrospect, the filing process is a necessary function to insure the safety and efficacy of the device. FDA clearance is a check list to help the manufacturer test the performance of the device. At that point, the manufacturer continue to maintain Quality Assurance for reliable performance. Viramed has and will continue to maintain the highest level of Good Manufacturing Practices to maintain quality service to you, the customer. For More Information Contact: |
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