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FOR IMMEDIATE RELEASE Borrelia burgdorferi B31 ViraStripe® FDA Clearance AnnouncementIVD Lyme ViraStripe®December 2009 -- Viramed receives clearance for sale and distribution of the Borrelia burgdorferi Line blot in the United States. The Borrelia burgdorferi B31 ViraStripe® is the first of it's kind. Using all ten of the CDC recommended native proteins. The IgG and IgM ViraStripe® is an cleared direct replacement for the Confirmatory Western Blot Method. Borrelia burgdorferi B31 ViraStripe Product Information The FDA notified Viramed that the 510k documentation for the IgG and IgM Lineblots 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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