510(k) clearance for Boston Biomedica:
This article was originally published in Clinica
Executive Summary
The FDA has given 510(k) approval to another four of Boston Biomedica's Accurun quality control products. Two of the devices are multi-analyte controls for blood bank viral marker screening and the others are single analyte controls for ToRCH (Toxoplasmosis, Rubella, Cytomegalovirus, and Herpes) - the group of infections which are especially harmful when contracted during pregnancy. The US company's range of Accurun products is used by blood banks, IVD manufacturers and clinical and research laboratories to ensure the accuracy of results of infectious disease tests by monitoring test performance.
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