PMA P920048S002

Device

ADEZA FETAL FIBRONECTIN EIK

Applicant

Hologic, Inc.

PMA number

P920048

Supplement

S002

Product code

LKV

Decision date

1998-08-14

Classification

Enzyme Immunoassay, Fetal Fibronectin

Generic name

ENZYME IMMUNOASSAY, FETAL FIBRONECTIN

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.