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U.S. Department of Health and Human Services

Product Classification

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Device placental alpha microglobulin-1 immunoassay
Definition A Placental Alpha Microglobulin-1 Immunoassay is a qualitative test intended to detect the presence of placental alpha microglobulin 1 (PAMG-1) in cervicovaginal secretions. The test is indicated as an aid to assess the risk of spontaneous preterm delivery in less than or equal to 7 days from the time of cervicovaginal sample collection in pregnant women with signs and symptoms of early preterm labor.
Physical State In vitro diagnostic test
Technical Method Qualitative immunochromatographic test
Target Area Cervicovaginal secretions
Review Panel Toxicology
Product CodeQBB
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Division of Chemistry and Toxicology Devices (DCTD)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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