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FDA Clears BD MAX System To Detect Group B Streptococcus

BD Diagnostics, a segment of BD (Becton, Dickinson and Company), has received FDA 510(k) clearance to market the BD MAX GBS Assay for Group B Streptococcus (GBS) on the BD MAX System.

BD Diagnostics said that the BD MAX System is a next-generation automated workstation for molecular testing designed to streamline workflow and offer walkaway automation to accommodate varying workloads for maximum lab efficiency and flexibility.

The BD MAX GBS assay on the BD MAX System represents an advance in neonatal healthcare by streamlining the GBS screening process and addressing the limitations of current culture methods by providing rapid, objective results.

BD Diagnostics added that with no visual interpretation required, the BD MAX GBS assay identifies GBS in just over an hour from Lim broth, which can help ensure that colonization status is available in the case of preterm delivery. By automating sample lysis through polymerase chain reaction detection, the BD MAX System offers walkaway convenience for up to 24 samples in approximately two and a half hours.

Philippe Jacon, president of BD Diagnostic Systems, said: “The BD MAX GBS assay is the first test in a complementary menu to BD’s infectious diseases portfolio. This achievement further demonstrates BD’s commitment to providing the best solutions to optimize lab efficiency and productivity that enable lab personnel to perform other tasks during a test run.”