QBB · Class III — High Risk (PMA approval required, life-sustaining) · Unknown
Classification
FDA Product Code
QBB
Device class
Class III — High Risk (PMA approval required, life-sustaining)
Regulation
—
Review panel
TX
Medical specialty
Unknown
Submission type
2
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.