All drug test kits must use a technology and methodology that meets all requirements of the Federal Food and Drug Administration under FDA 21 CFR applicable to commercial drug screening tests verified with a 510k notification letter and any related 510k annual reports. The products must meet all legal standards that relate to the legal validity of the tests when the tests are being used as a screening test for alcohol or illicit drug use. Screening/testing devices shall be as sensitive as possible but shall at least meet the general cutoff threshold levels established by the Substance Abuse and Mental Health Services Administration (SAMHSA). The screening/testing devices shall meet the cutoff threshold levels required by the Department where no SAMHSA standard exists, or where the Department is seeking a more sensitive cutoff threshold. Vendors shall provide documentation establishing the accuracy of the screening/testing devices, based on clinical test results. Vendors shall identify all substances the screening/testing device will not detect, or will not produce a positive result for the categories of drugs identified above. Additionally, vendors shall identify all substances known to cross-react, yielding a potentially false-positive result.
