American Bio Medica (ABMC) announced that the US Food and Drug Administration (FDA) has granted 510(k) marketing clearance for over-the-counter use to the company's Rapid TOX Cup II drug test product line.
The Rapid TOX Cup II is an all-inclusive; one-step drug test cup that produces accurate results within minutes without any need for manipulation of the device. The clearance applies to 13 commonly abused drugs (some at various cut-off levels).
OTC cleared products are categorized as CLIA waived tests, which are the most widely used tests in the clinical market (pain management, drug treatments, hospitals and physicians) and are also in increasing demand from occupational health and criminal justice applications.
ABMC Chief Executive Officer Melissa A. Waterhouse stated, “This marketing clearance for Rapid TOX Cup II will enable us to further penetrate clinical markets and is also expected to positively impact our current relationship with our laboratory alliance.
“We would expect to see a positive impact in sales rather quickly. Customers that are familiar with the superior quality of ABMC’s 100% US manufactured drug tests have been waiting for this product to be available as a CLIA waived test.
American Bio Medica Corporation manufactures and markets accurate, cost-effective immunoassay test kits, primarily point of collection tests for drugs of abuse. The Company and its worldwide distribution network target the workplace, government, corrections, clinical and educational markets.
ABMC’s Rapid Drug Screen®, Rapid ONE®, RDS® InCup®, Rapid TOX® and Rapid TOX Cup II test for the presence or absence of drugs of abuse in urine, while OralStat® tests for the presence or absence of drugs of abuse in oral fluids.
ABMC’s Rapid Reader® is a compact, portable device that, when connected to any computer, interprets the results of an ABMC drug screen, and sends the results to a data management system, enabling the test administrator to easily manage their drug testing program.