Premarket Approval (PMA)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.

• Trade Name: ADEZA FETAL FIBRONECTIN EIK
• Classification Name: enzyme immunoassay, fetal fibronectin
• Applicant: ADEZA BIOMEDICAL
• PMA Number: P920048
• Supplement Number: S002
• Date Received: 02/13/1998
• Decision Date: 08/14/1998
• Product Code: LKV [ Registered Establishments with LKV ]
• Advisory Committee: Clinical Chemistry
• Supplement Type: normal 180 day track
• Supplement Reason: labeling change - indications
• Expedited Review Granted?: Yes
• Combination Product: No

Approval Order 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.