PartoSure test

FDA premarket approval P160052 · Placental alpha microglobulin-1 immunoassay

PMA numberP160052

Approval

Applicant
Qiagen, Inc.
Received
November 30, 2016
Decision date
April 11, 2018 (APPR)
Supplements
1, latest October 11, 2019
Product code
QBB – Placental Alpha Microglobulin-1 Immunoassay

Official FDA PMA record

Approval order statement

Approval for the PartoSure test. The device is a rapid, qualitative test for detecting the presence of placental alpha microglobulin 1 (PAMG-1) in cervicovaginal secretions. The device is indicated as an aid to rapidly assess the risk of spontaneous preterm delivery in <= 7 days from the time of cervicovaginal sample collection in pregnant women with signs and symptoms of early preterm labor, intact amniotic membranes and minimal cervical dilatation (<3 cm), sampled between 24 weeks, 0 days and 34 weeks, 6 days gestation in women with a singleton gestation.