FDA has granted premarket notification (510(k)) clearance to a new immunoassay from Thermo Fisher Scientific Inc, Waltham, Mass, for specific detection of hydrocodone. The Thermo Scientific DRI hydrocodone assay has the requisite sensitivity to meet the newly proposed guidelines of the Substance Abuse and Mental Health Administration (SAMHSA). The assay is a homogeneous enzyme immunoassay that specifically detects hydrocodone at the SAMHSA-proposed 300 ng/mL cut-off and is crossreactive to the major metabolites hydromorphone and hydromorphone-glucuronide. The assay utilizes liquid, ready-to-use reagents that can be run in both qualitative and semiquantitative modes. Calibrators and controls are sold separately. For more information, visit Thermo Fisher Scientific.
