FDA WARNING_LETTER - BioCheck Inc - July 20, 2010

During a June-July 2010 inspection, the FDA determined BioCheck, Inc. manufactures and distributes in vitro diagnostic devices, including "Research Use Only" and "Investigational Use Only" reagents. The FDA found that product inserts for these reagents included intended use statements, test, preparation, and calculation methods, which classify them as devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act).

BioCheck was found to be promoting and marketing these devices in violation of the Act. Specific products cited for unapproved diagnostic claims include: 1. **Human Cardiac Specific Fatty Acid-Binding Protein (H-FABP) Enzyme Immunoassay Test Kit:** Marketed for diagnosing acute myocardial infarction (AMI) and as a biomarker for stroke, despite being labeled "For Research Use Only." 2. **Prostate Specific Antigen (PSA) Enzyme Immunoassay Test Kit:** Marketed for assessing response to treatment in prostatic cancer, despite being labeled "For Investigational Use Only." 3. **Carcinoembryonic (CEA) Antigen Enzyme Immunoassay Test Kit:** Marketed for detecting increased levels in various cancers, despite being labeled "For Investigational Use Only." 4. **Rubella IgG Enzyme Immunoassay Test Kit:** Marketed for evaluating serologic status to rubella virus infection and assessing immunity, despite being labeled "For Investigational Use Only."

These products are considered adulterated under