FDA Grants Diazyme Laboratories 510(k) Clearance to Market Its Myoglobin Assay for Clinical Chemistry Analyzers

SAN DIEGO, CA--(Marketwired - July 24, 2013) -

Diazyme Laboratories today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to market its Myoglobin assay. In line with current clinical needs, Diazyme’s Myoglobin latex-enhanced immunoturbidimetric assay can be utilized to measure Myoglobin in serum and plasma samples as an aid in the diagnosis of acute myocardial infarction. Utilization of this technology allows for highly reliable and precise test results, with minimal sample volumes. The Myoglobin assay is both fast and flexible with complete test results in minutes. Furthermore, the assay has been designed to work on most high throughput clinical chemistry analyzers, allowing users faster results and improved laboratory workflow.

Myoglobin is an important indicator of cardiac stress, muscle damage and provides early detection of necrosis in cardiac muscle. Diazyme’s new assay can assist in the evaluation of patients with myocardial damage.

“Diazyme’s Myoglobin assay provides a precise, flexible and cost effective test method for laboratories of virtually all sizes. Utilization of Diazyme’s technology in this assay will lead to overall improved workflow for laboratories,” said Dr. Chong Yuan, Managing Director of Diazyme Laboratories. “Diazyme’s latex enhanced immunoturbidimetric myoglobin is highly precise with excellent correlation to existing commercial myoglobin assay methods.”

Diazyme Laboratories is a division of General Atomics headquartered in La Jolla, California. Diazyme uses its enzyme platform technologies to develop innovative assays for clinical and research uses with reduced costs and improved performance. Products include diagnostic blood tests for cardiac markers, diabetes, nutritional assessment, liver disease, renal disease and electrolytes. Information regarding Diazyme’s enzyme technology and related products can be found on its website at www.diazyme.com.