Nov. 13, 2017—MedTest announced the commercial availability of four forensic use only urine drug tests for use on its BS-200, BS-480, and BA-800M chemistry analyzers. The four new assays are DRI Fentanyl, Cedia AB-PINACA (spice K2), Cedia UR-144/XLR-11 (spice K2), and DRI Ethyl Glucuronide.
In the United States, forensic use only products may only be sold to laboratories associated with the criminal justice system, as these products have not been cleared by the U.S. Food and Drug Administration via the 510(k) premarket notification process. These products are not intended to be used for in vitro diagnostic use and may not be used for medical or diagnostic purposes to identify ailments, dependency, or illness. To insure compliance with the FDA regulations for forensic use only products, MedTest will require customers to sign an acknowledgement letter that will be kept on file before these products will be shipped.
“With the emerging focus on the opioid crisis in the United States, MedTest is pleased to be able to offer these tests on our scalable chemistry instruments used in criminal justice laboratories. Whether test volume is low or high, MedTest can provide a ‘right-sized’ testing solution that will optimize laboratory operations and provide cost-effective instrument and reagents,” Wayne Brinster, CEO of MedTest, said in a statement.