ERBA Diagnostics, a fully integrated in vitro diagnostics company, has announced that it has received clearance from the US Food and Drug Administration (FDA) on the 510(k) premarket submission that the company had filed for its new clinical chemistry analyzer – the XL 200.
The XL-200 is a random access, clinical chemistry analyzer that can perform up to 400 tests per hour. Clinical chemistry analysis is one of the most widely and routinely performed diagnostics procedures in all clinical diagnostics laboratories.
ERBA Diagnostics interim CEO Sanjiv Suri said the company is excited with this clearance as it enables it to provide a comprehensive clinical chemistry system with instrument and reagent kits for routine clinical chemistry and electrolytes.
"We expect the XL 200 to complement and enhance the existing portfolio of immunology and hematology systems we offer to US hospitals, reference labs and physician office labs. We also expect the XL 200 to enhance our position with our key distributors to leverage their efforts and become more relevant to their customers with the enhanced offering.
"Industry analysts estimate that the size of the U.S. clinical chemistry market is approximately $5.0 billion.
"We expect the XL 200 to give us an entry in to this significant market and contribute to our revenue growth in future. Industry analysts have stated that they expect a rise in the number of insured in the U.S. will likely be compounded with other factors to revive the IVD market," Suri added.