Issue Date: 01/20/2007
Issued By: Office of Medical Products and Tobacco, Center for Devices and Radiological Health, Office of In Vitro Diagnostic Device Evaluation and Safety Division of Immunology and Hematology Devices
This guidance document was developed as a special controls guidance to support the classification of quality control material for cystic fibrosis nucleic acid assays into class II (special controls). A quality control material for cystic fibrosis nucleic acid assays is a device intended to help monitor reliability of a test system by detecting analytical deviations such as those that may arise from reagent or instrument variation in genetic testing. This type of device includes recombinant, synthetic, and cell line-based DNA controls.