SAN DIEGO, Calif. –
MagnaBioSciences (MBS) was very pleased to announce on Monday, March 19th, 2012, that its MICT® diagnostic instrument and TSH test have received FDA clearance under Section 510(k). This clearance confirms the safety and effectiveness of the MICT® technology and will allow MagnaBioSciences to expand sales domestically and globally.
"We are extremely excited to have received clearance of our MICT® technology from the FDA," said Bruce Gardner, Marketing Director for MagnaBioSciences. "We had every confidence that our MICT® technology and diagnostic testing system would receive FDA clearance. Now that we have successfully passed this stage we can focus our energies on getting our MICT®s into doctors’ offices here in the United States and around the world so that patients can benefit from our quick and accurate testing system.”
The MICT® technology system is intended for use in medical laboratories. It is an in-vitro diagnostic device that provides quantitative and qualitative information regarding the presence of biochemical analytes that are labeled with a superparamagnetic particle (SPMP). The system accomplishes this by measuring analyte-specific MICT® test cassettes. The information provided by the MICT® technology system can be used as an aid in the diagnosis of specific disease or physiological states. The system is designed to simplify laboratory procedures, while reducing test costs and improving disease diagnosis and patient care. Available tests include those related to women's health (TSH, LH, FSH), cardiac markers (c-TnI*, CK-MB*, Myoglobin*).
*Not available in the US