19 July 2012 | Regulatory | By BioSpectrum Bureau
FDA approves new BD BACTEC culture bottles
Singapore: BD Diagnostics, a segment of Becton, Dickinson and Company, obtained 510(k) clearance from the US Food and Drug Administration (FDA) for BD BACTEC Plus Aerobic/F blood culture bottles in plastic, previously only available in glass. Obtaining 510(k) clearance allows for increased convenience for customers without compromising the performance and quality of the system.
Mr Tom Polen, president, diagnostic systems, BD Diagnostics, said that, "BD is pleased to offer our customers the convenience of plastic, while continuing to deliver outstanding performance and rapid time-to-detection that drive better sepsis and healthcare-associated infection diagnostics. FDA clearance of the BD BACTEC Plus Aerobic/F blood culture plastic bottles represents BD's commitment to meeting customer needs without compromising clinical performance."
BD BACTEC Plus Aerobic/F blood culture plastic bottles provide customers with leading organism recovery through antibiotic neutralization and clear gram stain readability. The bottles run on currently available BD BACTEC systems, offering customers proven laboratory efficiency with optimized work flow and data management.
The BD BACTEC Blood Culture System is a fully-automated microbiology growth and detection system designed to detect microbial growth from blood specimens. Top-notch performance is preserved along with rapid time-to-detection, enabling better diagnostics and patient care.