Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers to notify the FDA at least 90 days in advance of their intent to market a medical device. Even though instant drug test kits are not classified as medical devices and therefore fall outside the FDA jurisdiction, many manufacturers obtain FDA 510k clearance to insure consumer security. FDA 510k Clearance certifies that the employee drug testing device passes FDA standards.
FDA 510k Clearance documents for our employee drug screening kits can be downloaded from our website, be found on the corresponding product pages or requested. You can check the 510k Clearance here: http://www.accessdata.fda.gov/scrIpts/cdrh/cfdocs/cfPMN/pmn.cfm
Forensic Use Only Drug Testing Kits are NOT 510k Cleared and are illegal for use by Businesses and/or Individuals.