New BD MAX Check-Points CPO assay receives FDA 510(k) clearance

BD (Becton, Dickinson and Company), a leading global medical technology company, along with Check-Points Health B.V., announced today that FDA 510(k) clearance was obtained for a molecular screening test for antibiotic-resistant carbapenemase-producing organisms (CPOs) on the fully-automated BD MAX™ System.

The BD MAX™ Check-Points CPO assay provides detection of the five most common carbapenemase genes directly from the patient specimen in approximately 2.5 hours, as compared to traditional methods that can take up to 24 hours to confirm a negative or longer for a final positive result. Early detection of patients colonized with these organisms can provide the necessary information to implement proper infection control measures.

Together with the BD Phoenix CPO Detect Panels, BD provides solutions for screening and infection management to support clinical microbiology laboratories in detecting CPOs, and helping hospitals implement robust programs to address antimicrobial resistance (AMR).

The launch of the BD MAX Check-Points CPO assay in the US is another example of BD’s commitment to helping prevent and reduce the spread of healthcare associated infections (HAIs). Our solutions for CPO detection and identification are an important part of our portfolio of products for infection prevention, diagnostics, and surveillance and monitoring that help hospitals combat antimicrobial resistance.”

Nikos Pavlidis, vice president and general manager, molecular diagnostics and women’s health for BD

This assay joins BD’s comprehensive healthcare-associated infections diagnostics portfolio, which aims to reduce transmission and outbreak of deadly pathogens. The BD MAX™ product menu also includes syndromic panels for gastrointestinal infections, as well as reproductive and sexually transmitted infections, which aid laboratory professionals in their efforts to deliver diagnostic results that inform clinicians to help enhance patient outcomes, while improving laboratory efficiency. The BD MAX™ system also features an open system capability, allowing for streamlined workflow of laboratory developed tests and for additional assays via BD partner collaborations.

Citations

Please use one of the following formats to cite this article in your essay, paper or report:

  • APA

    Becton, Dickinson and Company. (2019, October 30). New BD MAX Check-Points CPO assay receives FDA 510(k) clearance. News-Medical. Retrieved on October 21, 2020 from https://www.news-medical.net/news/20191030/New-BD-MAX-Check-Points-CPO-assay-receives-FDA-510(k)-clearance.aspx.

  • MLA

    Becton, Dickinson and Company. "New BD MAX Check-Points CPO assay receives FDA 510(k) clearance". News-Medical. 21 October 2020. <https://www.news-medical.net/news/20191030/New-BD-MAX-Check-Points-CPO-assay-receives-FDA-510(k)-clearance.aspx>.

  • Chicago

    Becton, Dickinson and Company. "New BD MAX Check-Points CPO assay receives FDA 510(k) clearance". News-Medical. https://www.news-medical.net/news/20191030/New-BD-MAX-Check-Points-CPO-assay-receives-FDA-510(k)-clearance.aspx. (accessed October 21, 2020).

  • Harvard

    Becton, Dickinson and Company. 2019. New BD MAX Check-Points CPO assay receives FDA 510(k) clearance. News-Medical, viewed 21 October 2020, https://www.news-medical.net/news/20191030/New-BD-MAX-Check-Points-CPO-assay-receives-FDA-510(k)-clearance.aspx.

Comments

The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
You might also like... ×
BD launches first automated phenotypic test for CPO detection