STATEMENT ON FORENSIC USE PRODUCTS
Before a point-of-care drug test can be used for the purpose of diagnosing or treating diseases or other conditions in a healthcare setting, that test must be cleared by the FDA. However, many popular assays (i.e., the specific drugs being tested) and methods (e.g., saliva) are currently incapable of being FDA-cleared because there is too much risk of “false” results. Common examples include all saliva-based point-of-care drug tests and any drug test that tests for EtG, fentanyl, and K2/Spice.
If a point-of-care drug test has not been FDA-cleared, we market it as being for “Forensic Use Only.” This means that it has not been cleared by the FDA, is not a “CLIA Waived” test, and is intended only for law enforcement purposes.
If you are a healthcare provider and are providing testing under a CLIA Certificate of Waiver, we recommend that you avoid purchasing or using any point-of-care test that we have designated as being for “Forensic Use Only.” Doing so could jeopardize your CLIA Certificate of Waiver.
Instead, we recommend that you purchase and use our 12-Panel offering.
If you have any questions about the intended use or appropriate setting for this device, please do not hesitate to contact us.