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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DevicePartoSure test
Generic Nameplacental alpha microglobulin-1 immunoassay
Applicant
QIAGEN Inc
19300 germantown road
germantown, MD 20874
PMA NumberP160052
Date Received11/30/2016
Decision Date04/11/2018
Product Code QBB 
Docket Number 18M-1581
Notice Date 04/27/2018
Advisory Committee Toxicology
Expedited Review Granted? No
Combination Product No
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.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 
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