Diamedix files a 510(k) premarket submission with the FDA for its Mago4S assay system

IVAX Diagnostics, Inc. (AMEX: IVD) announced today that its U.S. subsidiary headquartered in Florida, Diamedix Corporation, has filed a 510(k) premarket submission with the U.S. Food and Drug Administration (“FDA”) for its next -generation fully automated Enzyme-linked Immunosorbent Assay (“ELISA”) system for autoimmune and infectious disease testing, named the Mago®4S. IVAX Diagnostics believes the new instrumentation will provide a flexible, efficient and cost-effective solution to today's high-performance laboratory demands.

Key enhancements of the Mago®4S compared to the current Mago® Plus available in the U.S. are:

  • Ability to process samples in ELISA and Immunoflourescence Assays (“IFA”) methods simultaneously. This walk away and random access system will be capable of performing Infectious Disease tests (ELISA and/or IFA) or Autoimmune tests (ELISA and/or IFA).
  • Expanded capabilities with embedded Windows® XP software architecture and programming that allows interpretation, storage and recall of results, standard curves and internal quality control (“QC”), and retrieval of archived data.
  • Ability to perform up to 12 ELISA tests or up to 16 IFA tests or a combination in parallel, with any combination of 4 ELISA plates/IFA slide holders.
  • Time saving set-up procedures and features, such as easy, fast-loading holders for IFA slides.
  • Ability to export data to an external PC; e.g., for use with Levey-Jennings or Westgard QC rules.
  • Improved workflow with pre-programmed and reagent partners programmed tests performing in parallel.
  • Consolidated space requirements with a built in Microsoft Windows XP® Professional computer eliminating the need for a separate workstation.

Dr. Charles Struby, CEO and President of IVAX Diagnostics said, “The Mago®4S was introduced at the American Association for Clinical Chemistry Expo in July where the instrumentation’s potential to address the critical needs of the reference laboratory manager was met with great interest. We perceived there to be a great amount of excitement surrounding the new system, and we look forward to proceeding through the FDA process and making this product commercially available following our receipt of regulatory approval. We are also continuing our efforts to introduce similar analyzer instrumentation in countries outside the U.S.”

He concluded, “We believe that the future commercial release of this product, combined with our recent distribution agreements, brings IVAX Diagnostics yet another step closer towards creating a stronger and more competitive company by distributing test kits that meet and/or exceed patients’ and their physicians’ needs for accurate and efficient in vitro diagnosis.”

Source:

IVAX Diagnostics, Inc

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