The FRX System is to be used by trained personnel in CLIA certified laboratories and is for use with buccal samples collected directly from patients. The FRX CYP2C19 test is intended to enable clinicians to identify patients with mutations in the *2,*3 and *17 loci of the CYP2C19 gene and is indicated for use as an aid to clinicians in determining strategies for therapeutics that are metabolized by the CYP2C19 gene product.