Official FDA 510k Clearance Certification Documentation for AlcoMate Decision Summary K041334. FDA 510 Clearance Certification found on www.EmployeeDrugTestingAce.com within the Resource Library. Aka: www.EDTAce.com This fast, reliable hand-held employment and pre-employment alcohol concentration breath testing system features one button operation and an active, easy-to-replace PRISM Sensor Technology pressure sensor for accurate deep lung air sampling of Blood Alcohol Concentration (BAC). Deep lung air sampling has been shown to best correlate to BAC (Blood Alcohol Concentration) and the improved module sensor technology assures that the user exhales with the required force and duration. Sensor Modules should be replaced every 200 tests or at least once yearly. DOT/NHTSA approved. FDA 510k cleared. Trusted by Law Enforcement, Medical, Educational, Corporate and Social Service Professionals as well as consumers. Each Alcohol testing kit includes: AlcoMate Premium Breathalyzer, User's Manual, Pre-Installed Sensor Module, 1 additional Sensor Module, 2 AA Batteries, 55 Mouthpieces, Car Adapter Power Cord, Carrying Pouch, Silver Plastic Casing with light grey trim, Hand Strap, Deluxe Anti Fiber Carrying Case. 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: Single Item, DOT Approved, NHTSA Approved, FDA 510k Cleared, Meets US Coast Guard Requirements, ISO 9002 Certified, Government Approvals for Law Enforcement, All-Inclusive Alcohol Test Device ... Drug Testing Kit Product Codes: AL7000FKit, AL 7000 F-Kit Aka: www.Employee-Drug-Testing-Ace.com