PartoSure test
FDA premarket approval P160052 · decided 2018-04-11
Approval details
- PMA number
- P160052
- Trade name
- PartoSure test
- Generic name
- Placental alpha microglobulin-1 immunoassay
- Applicant
- Qiagen, Inc.
- Date received
- 2016-11-30
- Decision date
- 2018-04-11
- Days to decision
- 497 days
- Decision code
- APPR
- Product code
- QBB
- Advisory committee
- Clinical Toxicology
- Expedited review
- No
- Location
- Germantown, MD
- 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
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| ipsogen JAK2 RGQ PCR Kit (K172287) | Qiagen, Inc. | 2018-01-12 |
| ipsogen JAK2 RGQ PCR Kit (DEN160028) | Qiagen, Inc. | 2017-03-27 |