Healstone Obtains OTC Clearance from the FDA for their Accurate Brand Drug of Abuse Test Cups

Healstone’s AccurateTM Drug of Abuse Urine Test Cup has obtained FDA 510(k) OTC Clearance (k221871) for its rapid immunoassay, which can be used for the preliminary qualitative detection of the 15 most-commonly abused drugs in North America including amphetamines, barbiturates, benzodiazepines, buprenorphine, cocaine, ecstasy, opiates, and oxycodone in urine.




The AccurateTM Drug of Abuse OTC Test Cup can be used to test up to 15 different drugs with customizable configurations available. The test is easy-to-use and can be administered at home or in a professional setting with results available within 5 minutes. The test cup yields highly accurate, sensitive, and specific results, and has been cleared to detect both high and low cutoffs for AMP, COC, MET and OPI.


The clearance of this test cup adds to the portfolio of products available from Orient Gene to aid in the early detection of drugs to contribute to the mission of reducing the effects of substance abuse on communities.