Tuberculosis (TB) blood culture tests will require FDA clearance
This article was originally published in Clinica
Automated blood culturing systems used in disease diagnosis must obtain US premarket notification clearance from October 25th, 1995. The FDA says it is revoking the exemption from 510(k) requirements for these devices because of significant questions of safety and effectiveness. It cites the reported failure of devices used in detecting Mycobacterium tuberculosis.