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FDA Clears Beckman Coulter PCT Assay

NEW YORK (360Dx) – Beckman Coulter Diagnostics and Diazyme Laboratories today announced the US Food and Drug Administration cleared Beckman Coulter's procalcitonin assay.

The assay is the first homogeneous PCT assay for use on Beckman Coulter AU model chemistry analyzers and can be used to manage bacterial infections and sepsis. The fully automated assay, which features a latex-enhanced immunoturbidimetric methodology based on antibodies for enhanced sensitivity and specificity, can be used with Beckman Coulter AU analyzers, models 480, 680, and 5800.

The company is partnering with Diazyme Labs, a cGMP and ISO 13485-certified medical device manufacturer, to make the assay available to distribute the PCT assay.

Terms of their agreement were not disclosed.