The FDA has assigned Class II special controls for Vela Diagnostics’ Sentosa SQ HIV drug resistance genotyping assay, the first assay of its type that uses next-generation sequencing technology.
Under the special controls, the assay’s intended use must specify what is being measured (RNA or DNA), the genes in which mutations are detected, the clinical indications for test use, the sample type, and the specific populations to be tested.
The agency said it must be noted that the device isn’t intended for use in aiding a diagnosis of HIV infection or confirming the presence of HIV infection.
The assay’s labeling must give a detailed description of all procedures, from sample collection to final result reporting, all device components, the test procedure’s control elements, instrument requirements, and reagents that are required for use but not provided with the device. It must also provide a list of the specific mutations it detects and a thorough explanation of how test results are interpreted.