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
| Device | PartoSure test |
| Classification Name | Placental Alpha Microglobulin-1 Immunoassay |
| Generic Name | Placental Alpha Microglobulin-1 Immunoassay |
| Applicant | QIAGEN Inc |
| Date Received | 2016-11-30 |
| Decision Date | 2018-04-11 |
| Notice Date | 2018-04-27 |
| PMA | P160052 |
| Supplement | S |
| Product Code | QBB |
| Docket Number | 18M-1581 |
| Advisory Committee | Toxicology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | QIAGEN Inc 19300 Germantown Road germantown, MD 20874 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P160052 | Original Filing | |
| S001 | 2018-05-11 | Normal 180 Day Track No User Fee |