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  1. Device Approvals, Denials and Clearances

PartoSure Test - P160052

PartoSure Test - P160052

PartoSure Test

This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name: PartoSure test
PMA Applicant: Parsagen Diagnostics, Inc.
Address: Harvard Innovation Launch Lab, 114 Western Avenue, Boston, MA 02134
Approval Date: April 11, 2018
Approval Letter: https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160052a.pdf

What is it?
The PartoSure test is used to detect the presence of placental alpha microglobulin-1 (PAMG-1), a protein present in the amniotic fluid throughout pregnancy. PAMG-1’s presence in the vaginal cavity of pregnant women carrying only one fetus, who have signs and symptoms of preterm labor, but who do not have ruptured amniotic membranes, may be associated with spontaneous preterm delivery within 7 days of testing. The PartoSure test includes a sterile flocked swab, a vial with an extraction solvent, and a lateral flow test strip.

How does it work?
The health care provider obtains a sample from the patient using the provided sterile vaginal swab. The swab is placed in the solvent vial for 30 seconds, and then the swab is discarded. The test strip, similar to the technology used for pregnancy tests, is dipped into the solvent vial. The result, which indicates whether the patient is likely to deliver too early (within 7 days of testing), should be read from the test strip within five to ten minutes.

When is it used?
The PartoSure test is intended for use with pregnant women carrying only one fetus, experiencing signs and symptoms of early preterm labor, intact amniotic membranes, and minimal cervical dilatation (<3 cm). The test is used between 24 weeks, 0 days and 34 weeks, 6 days gestation.

What will it accomplish?
Health care providers can use the PartoSure test to help assess the risk of spontaneous preterm delivery within 7 days of testing in pregnant women for whom the device is intended to be used. The test result can be used as part of the clinical assessment of the patient when making patient management decisions: for example, whether to schedule a follow-up visit or to admit the patient for treatment that may improve neonatal outcomes.

When should it not be used?
The test is not intended for pregnant women with multiple fetuses (e.g., twin pregnancies).
This test should not be used in pregnant women without signs and symptoms of preterm labor.

Additional information (including warnings, precautions, and adverse events): Summary of Safety and Effectiveness Data (SSED) and labeling are available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160052