The screen is meant for people without history of heart disease, agency says.
Patients with Lp-PLA2 activity greater than the level of 225 nanomoles per minute per milliliter are at increased risk for heart attacks.
The test is designed for people with no history of heart disease, and it appears to be especially useful for women, and black women in particular, the agency said.
"A cardiac test that helps better predict future coronary heart disease risk in women, and especially black women, may help health care professionals identify these patients before they experience a serious [heart disease] event, like a heart attack," Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health, said in an agency news release.