Beckman Coulter gets FDA nod for blood banking analyser
Beckman Coulter gets FDA nod for blood banking analyser

Beckman Coulter Diagnostics has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its PK7400 automated microplate system and its reagents.

The company has developed the PK7400 automated microplate system for use in blood donor and plasma centres, as well as large reference laboratories.

Designed to deliver high throughput for a single analyser, the PK740 automated microplate system is now marketed in countries across Europe, Canada and the US.

Beckman Coulter chief medical officer Dr Shamiram Feinglass said: “Blood donation is critically important under normal circumstances, as one donation can save up to three lives, but even more so now.”

The PK7400 system can process up to 300 samples per hour

The PK7400 automated microplate system has the capacity to process up to 300 samples per hour with a maximum of 12 tests per sample.

The system, which is provided with advanced liquid and ready-to-use reagents, enables to test multiple assays in a single batch without decreasing the throughput.

In addition, the assay menu is comprised of ABO blood grouping, Rh typing, weak D testing, Rh-Kell phenotyping, as well as syphilis and CMV qualitative screening.

Beckman Coulter chemistry and immunoassay business general manager vice president Kathleen Orland said: “Our PK7400 is designed to optimise workflow, minimize hands-on time and increase productivity, allowing users to focus their time on protecting the health and safety of donors, patients and blood centre staff.”

In September 2016, DiaSorin partnered with Beckman Coulter Diagnostics to launch Hepatitis and HIV diagnostic products in the US.

Under the deal, the companies will provide US customers with the Liaison XL Hepatitis A, B, C and HIV products.

Beckman Coulter offers diagnostic systems that are suitable for complex biomedical testing applications. The company’s systems are used in hospitals, reference laboratories and physician office settings across the world.

Related: LifeSignals wireless biosensor wins FDA clearance

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