Issue Date: 09/19/1996
Issued By: Office of Medical Products and Tobacco, Center for Devices and Radiological Health
This document represents current FDA thinking and provides suggestions for 510 (k) submissions of Tumor Associated Antigen in vitro diagnostic devices employing immunochemistry methodology. It is based on 1) current basic science, 2) clinical experience, 3) the Safe Medical Device Act of 1990 and 4) FDA Code of Federal Regulations (CFR). As advances are made in science and medicine, these review criteria will be evaluated and revised as necessary.