Atossa Genetics files 510(k) pre-marketing notification with FDA for ForeCYTE breast aspirator

Atossa Genetics, the breast health company, has announced the filing of 510(k) pre-marketing notification with the US Food and Drug Administration (FDA) for its ForeCYTE breast aspirator, including the ForeCYTE breast pump and patient collection kit.

ForeCYTE breast aspirator, ForeCYTE breast pump and patient collection kit are intended for use in the collection of nipple aspirate fluid for laboratory cytological testing.

The FDA, in accordance with Section 510(k) of the Federal Food, Drug, and Cosmetic Act, typically has 90 days to clear the device for commercial distribution, request additional information, or find that the device is not substantially equivalent to the predicate device.

The company anticipates re-launching its ForeCYTE device after receiving the FDA 510(k) clearance.