Official FDA 510k Clearance Certification for BreathScan K060761 Decision Summary. This FDA 510 Clearance Certification Documentation and more found on www.EmployeeDrugTestingAce.com/Library. Aka: www.EDTAce.com This fast, disposable, portable drug test kit for work place employee alcohol screening is proven to be highly accurate and FDA 510k cleared. It is alcohol reactive only, with no false positive employee drug testing results. Complete instructions included. This alcohol drug test has an average shelf life at room temperature of 9-12 months. In the 1930's, it was discovered that the alcohol content of exhaled air from a deep lung breath accurately reflected the alcohol content in the blood (Blood Alcohol Concentration or BAC). Our reliable breath tests for alcohol are highly recommended and approved for all government agencies or anyone needing employment drug testing. All work place Alcohol Drug Tests are near laboratory accurate, reliable, meet commercial requirements and are non-invasive. There is zero contact with employee saliva or breath, making them tamper proof. These employee alcohol drug tests are alcohol reactive only, with no false positive results. Note: Alcohol generally remains in the human body for 4-6 hours. Impairment varies in each individual due to physical size, weight, activity levels, eating habits and alcohol tolerance. Features and Benefits: Box of 25, FDA 510k Cleared, CLIA Waived, All-Inclusive Alcohol Test Device, No Contact with Breath Makes this Employee Drug Test Tamper Proof, Pass/Fail Result Reading, Uses Breath to Test the Presence of Alcohol, Meet Commercial Requirements, Instant Near Laboratory Accurate Results, Alcohol Drug Test Results can be Photocopied, 9-12 Month Average Shelf Life, Alcohol Reactive Only - No False Positives, No Contact with Saliva, Donor Friendly - Non-Invasive, No Special Training Required, Simple Procedure - Easy ... Drug Testing Kit Product Codes: BS .02, BS02, BS .05, BS05, BS .08, BS08 Aka: www.Employee-Drug-Testing-Ace.com