FDAnews
www.fdanews.com/articles/203377-proov-awarded-ce-mark-for-pregnancy-hormone-self-test-kit

Proov Awarded CE Mark for Pregnancy Hormone Self-Test Kit

June 30, 2021

Boulder, Colo.-based Proov’s self-test kit to confirm the presence of the progesterone hormone after ovulation has received the CE mark.

Proov’s tests evaluate urine for the presence of PdG, an analyte of progesterone, which is produced by the ovaries to prepare the uterine lining for implantation.

Prior to the patented test, no diagnostic test could assess ovulation quality to determine if a woman produced enough progesterone to confirm a healthy ovulation, giving her the best chance at successful conception, the company said.

Proov had previously received FDA 510(k) clearance for the PdG test kit.

View today's stories