Endometrial Cell Collection With the PadKit

"The interlabial pad is classified as a Class 1 device by the FDA and the device is exempt from requiring a 510(k) approval.~The interlabial pad is worn for 4-6 consecutive hours and collects cells shed from the cervix and uterine cavity. The pad is then removed and placed in the smaller, inner tube that contains the transport solution. After replacing the lid securely, it is then carefully placed back inside the larger outer tube with the outer lid secured and returned to the original box. The entire box is placed in the polybag and mailed back to the lab for analysis."