FDA Reclassifies Pelvic Mass Test

May 20, 2011
The FDA is down-classifying ovarian adnexal mass assessment score test systems from Class III into Class II with special controls. The test system measures one or more proteins in serum or plasma to determine the likelihood that an adnexal pelvic mass in the fallopian tubes or ovaries is malignant. The tests are used to identify women who should be referred to a gynecological oncologist for surgery, despite negative results from other clinical and radiographic tests for ovarian cancer. It is used in conjunction with a clinical and radiological evaluation.
International Medical Device Regulatory Monitor