ADEZA FETAL FIBRONECTIN EIK

FDA premarket approval P920048/S002 · decided 1998-08-14

Approval details

PMA number

P920048

Supplement

S002

Supplement type

Normal 180 Day Track

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

ADEZA FETAL FIBRONECTIN EIK

Generic name

ENZYME IMMUNOASSAY, FETAL FIBRONECTIN

Applicant

Hologic, Inc.

Date received

1998-02-13

Decision date

1998-08-14

Days to decision

182 days

Decision code

APPR

Product code

LKV

Advisory committee

Clinical Chemistry

Expedited review

Yes

Location

Sunnyvale, CA

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

510(k) clearances by this applicant