Category 1: Field-Testing Devices/Materials All Field-Testing Devices/Materials must use technology and methodology that meets all requirements of the Federal Food and Drug Administration under FDA 21 CFR applicable to commercial illicit substance field-tests, devices and/or materials 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 Field-Testing Devices/Materials when the tests are being used as a test for alcohol or illicit substance use. Field-Testing Devices/Materials must be as sensitive as possible. The Department’s threshold for field testing devices/materials is zero, as the Department has zero tolerance for illicit substances. The Bidder shall provide documentation establishing the accuracy of the Field-Testing Devices/Materials, based on clinical test results. The Bidder shall identify all substances the Field-Testing Devices/Materials will not detect or will not produce a positive result for all illicit substances. Additionally, the Bidder shall identify all substances known to cross-react with the Field-Testing Devices/Materials. The Department reserves the right to negotiate with the successful Bidders Field-Testing Devices/Materials for additional illicit substances, based on the needs of the Department, with the same discounting applied. All submissions must include product literature that clearly identifies each referenced product. The Department is seeking Field-Testing Devices/Materials to use an alternative to urinalysis testing. These tests may include, but are not limited to, hair samples, sweat patches, oral fluid, breathalyzer etc. Bidders must clearly state/define what substances each of their Field-Testing Devices/Materials test for.
