Enzyme Immunoassay, Fetal Fibronectin
Basic Information
- Device Name
- Enzyme Immunoassay, Fetal Fibronectin
- Trade Name
- ADEZA FETAL FIBRONECTIN EIK
- PMA Number
- P920048
- Supplement Number
- S002
- Device Class
- FDA Class 3
- Product Code
- LKV
- Generic Name
- ENZYME IMMUNOASSAY, FETAL FIBRONECTIN
- Medical Specialty
- Unknown
- Advisory Committee
- Clinical Chemistry
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- August 14, 1998
- Date Received
- February 13, 1998
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- Y
Advisory Committee Statement
Approval for a rapid, qualitative test for detecting the presence of fetal fibronective (fFN) in cerviocovaginal secretions. The device, as modified, will be marketed under the trade name Fetal Fibronectin Rapid System and is indicated as an aid to rapidly assess the risk of preterm delivery in <7 or <14 days from the time of cervicovaginal sample collection in pregnant women withsigns 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. The device is further indicated for use in conjunction with other clinical information as an aid to rapidly assess the risk of preterm delivery in <34 weeks, 6 days when a cerviocovaginal sample is obtained during a routine prenatal visit between 22 weeks, 0 days and 30 weeks, 6 days of gestation in women with a singleton pregnancy.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LKV | Enzyme Immunoassay, Fetal Fibronectin | FDA class 3 | Unknown |