Corgenix Announces Filing of 510(k) Premarket Notification for FDA Clearance of TxBCardio™ Assay
17 Dec 2013
Corgenix Medical Corporation has announced that in collaboration with Randox Laboratories, the first premarket notification has been filed with the U.S. Food and Drug Administration pursuant to Section 510(k) of the U.S. Federal Food, Drug and Cosmetic Act for the TxBCardio™ immunoturbidimetric (IT) assay.
The Company stated that the TxBCardio brand was established to better emphasize the importance of the thromboxane biomarker while expanding into new products and technologies.
The filing is based on TxBCardio’s substantial equivalence to the Corgenix AspirinWorks ELISA assay, 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. Co-development of the TxBCardio IT assay enables the 11dhTxB2 AspirinWorks assay to be run on clinical chemistry platforms for higher-volume laboratories and in hospitals.
“This 510(k) application marks a substantial step forward in our collaborative development efforts for thromboxane testing,” said Douglass Simpson, Corgenix President and CEO. “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.”
The assay would be manufactured at Randox Laboratories in the United Kingdom. Both Corgenix Medical and Randox Laboratories would be selling the new test worldwide under the TxBCardio brand name.
The safety and efficacy of the TxBCardio assay has not yet been evaluated by the FDA.
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AspirinWorks Test Kit
CorgenixAspirin is an anti-platelet drug that works to prevent heart attacks and strokes by reducing the production of thromboxane, the chemical that makes platelets sticky. Although we can’t measure thromboxane directly, we can easily and non-invasively measure 11-dehydro thromboxane B2, its chemical biomarker’ using the AspirinWorks Test. In fact, the AspirinWorks Test is the only FDA-cleared test that accurately determines aspirin effect by measuring levels of this biomarker. A low level of the biomarker in the urine means that aspirin is working to reduce thromboxane production. High levels of the biomarker may mean that your dosage of aspirin is not effective for decreasing the risk of a heart attack or stroke, and it’s time for you and your doctor to consider increasing the dose or changing your treatment strategy.