| 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. |
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| Device | PartoSure test |
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| Generic Name | Placental alpha microglobulin-1 immunoassay |
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| Applicant | Qiagen, Inc.
19300 Germantown Rd.
Germantown, MD 20874 |
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| PMA Number | P160052 |
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| Date Received | 11/30/2016 |
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| Decision Date | 04/11/2018 |
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| Product Code |
QBB |
| Docket Number | 18M-1581 |
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| Notice Date | 04/27/2018 |
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| Advisory Committee |
Toxicology |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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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 |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
|
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| Post-Approval Study | Show Report Schedule and Study Progress |
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| Supplements: |
S001 |
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