Gold Standard Diagnostics, Corp. Receives 510(k) for the AIX1000 System
DAVIS, California, (March 7, 2016) — Gold Standard Diagnostics, Corp. announced today that the U.S. Food and Drug Administration issued a 510(k) for the AIX1000® Rapid Plasma Reagin (RPR) Automated Test System.The AIX1000® is a fully automated system for RPR syphilis testing.
The AIX1000® system fully automates the RPR test procedure from sample loading to result interpretation for titers and screens. Digital images of each result are retrievable on demand, for review anytime. Interpretation of results is completed by a pattern-recognition algorithm that is both objective and consistent.
John Griffiths, CEO said, “We are excited to bring this new, innovative technology to clinical laboratories. The AIX1000® automates a test that has historically been manual, labor intensive and subjective. This fully automated solution allows laboratories to continue to perform the traditional syphilis testing algorithm while improving efficiencies and reducing costs. RPR is now fully automated with all of the features and benefits of an immunoassay processor.”
About Gold Standard Diagnostics, Corp.
Gold Standard Diagnostics, Corp. is a privately held clinical diagnostics company based in Davis, California. The company develops, manufactures and distributes a portfolio of instrumentation and diagnostic products to clinical laboratories in the U.S., EMEA, Asia, and South America. Current product offerings include the Thunderbolt® instrument, an open format platform for enzyme and chemiluminescence immunoassays, and an extensive menu of serology tests used in the areas of autoimmune disease, infectious disease and endocrinology.