December 2, 2020 – MOUNTAIN VIEW, California – FOR IMMEDIATE RELEASE
Specific Diagnostics today announced that it has received ISO-13485 certification through the International Organization for Standardization. A QMS conforming to ISO-13485 meets the highest FDA standards applicable to the manufacture of medical devices.
Specific, which manufactures the Reveal rapid antimicrobial susceptibility testing system and associated disposables, has already started its European market launch. While not required for European sales, the ISO-13485 quality management system certification will give European hospital customers the added assurance that Specific’s instruments and disposables have been manufactured under the highest standards applicable to medical devices.
“Our Company is gratified to have received certification that we operate an ISO-13485-compliant quality management system, the international standard for the manufacture and deployment of medical devices,” said Dr. Paul A. Rhodes, Specific’s CEO. “This designation, along with our CE-IVD registration announced in October, provide assurance to the customers that we are now engaging in Europe that we are a trusted vendor that they can rely upon for instruments performing critical determinations of antimicrobial susceptibility.”
Specific’s Reveal furnishes a phenotypic MIC directly from a positive blood culture sample in an average of less than 5 hours, with high accuracy, as determined by a preclinical study of 104 patient samples conducted at the Henry Ford Health System in Detroit, Michigan. Based upon arrays of printed sensors responsive to the volatiles emitted by growing microorganisms, the Reveal system has the high throughput, low cost, antibiotic menu, and ease of use to prompt wide adoption.
“As we move to make Reveal available to clinics in Europe, we were determined to complete the ISO-13485 certification process to ensure we meet the highest standards applicable to medical device manufacturers, and we have done-so,” said Specific COO Raymond Martino. “The Reveal system, which is currently available in Europe, will rapidly make an impact on clinical best practice for bacteremia and other time-sensitive infections.”
Specific Diagnostics has developed in vitro diagnostic systems based upon a unique, patented metabolomic signature technology that enables rapid detection and identification of microorganisms as they grow in culture. Its first commercial application applies this fundamental new platform to the rapid determination of antimicrobial susceptibility directly from positive blood cultures, as well as isolate dilutions. Specific is based in Mountain View, CA.
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