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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceADEZA FETAL FIBRONECTIN EIK
Generic NameENZYME IMMUNOASSAY, FETAL FIBRONECTIN
ApplicantHologic, Inc.
1240 Elko Dr.
Sunnyvale, CA 94089
PMA NumberP920048
Supplement NumberS002
Date Received02/13/1998
Decision Date08/14/1998
Product Code LKV 
Advisory Committee Clinical Chemistry
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? Yes
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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.
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