Seattle-based Atossa Genetics said Tuesday it has submitted a 510(k) premarket notification for its ForeCYTE Breast Aspirator, which is used to draw out fluid from the nipple for cytological testing. The submission includes the ForeCYTE breast pump and patient collection kit.
The submission follows an October recall of the breast cancer screening test and a February FDA warning letter claiming Atossa made design changes to the collection process without obtaining the necessary clearance. The agency said the modified process could lead to false results.
The FDA has 90 days to grant marketing clearance, request additional information or reject the 510(k). Atossa plans to relaunch the ForeCYTE system once clearance is gained.
On Dec. 12, the FDA issued a safety communication warning women that nipple aspiration is not an adequate substitute for mammography. — Lena Freund