Corgenix Medical, in collaboration with Randox Laboratories, has filed first 510(k) premarket notification with the US Food and Drug Administration (FDA) for the TxBCardio immunoturbidimetric assay.
According to Corgenix Medical, TxBCardio brand was established to better emphasize the importance of the thromboxane biomarker while expanding into new products and technologies.
The company has filed the 510(k) premarket notification based on TxBCardio’s substantial equivalence to the Corgenix AspirinWorks ELISA assay.
Corgenix AspirinWorks ELISA assay is a simple urine test that is FDA cleared to measure levels of 11-dehydro thromboxane B2 (11dhTxB2) to determine aspirin effect in apparently healthy individuals.
The TxBCardio IT assay co-development enables the 11dhTxB2 AspirinWorks assay to be run on clinical chemistry platforms for higher-volume laboratories and in hospitals.
Corgenix Medical president and CEO Douglass Simpson noted this 510(k) application marks a substantial step forward in the company’s collaborative development efforts for thromboxane testing.
"Along with our strategic partner and master distributor, the ELITech Group, we intend to expand the application of this new assay onto additional platforms over the next 18-24 months," Simpson added.
Randox Laboratories would manufacture the assay in the UK. Corgenix Medical and Randox Laboratories would be selling the new test across the globe under the TxBCardio brand name.
Safety and efficacy of the TxBCardio assay has yet to be evaluated by the FDA.