American Bio Medica Corp, Kinderhook, NY, has received FDA 510(k) clearance for its Rapid TOX Cup ®, a patent-pending drug screen in an all-inclusive cup platform.
The wide-mouth cup facilitates collection, testing, and shipment for confirmation. An attached temperature strip helps ensure specimen integrity; a specimen-validity test strip is optional. The product is available in clinical markets.
Stan Cipkowski, the company’s CEO, said the device is popular in the criminal justice sector because it is user-friendly and cost-effective. “This clearance opens up additional markets to ABMC, and also allows us to market the product to those customers that want an FDA-cleared product,” he says.
Results can be photocopied for record-keeping purposes.
The biotechnology company develops, manufactures, and markets immunoassay diagnostic test kits, such as point-of-collection tests for drugs of abuse. Customers include government entities, corrections, private-sector companies, clinical, and educational markets.
