ADEZA FETAL FIBRONECTIN EIK

FDA premarket approval P920048/S001 · decided 1997-01-08

Approval details

PMA number

P920048

Supplement

S001

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

1996-06-26

Decision date

1997-01-08

Days to decision

196 days

Decision code

APPR

Product code

LKV

Advisory committee

Clinical Chemistry

Expedited review

No

Location

Sunnyvale, CA

Statement

APPROVAL FOR A MODIFICATION OF THE INTENDED USE STATEMENT AS FOLLOWS: "THE DEVICE IS FURTHER INDICATED FOR USE IN CONJUNCTION WITH OTHER CLINICAL INFO AS AN AID IN ASSESSING THE RISK OF PRETERM DELIVERY IN < 34 WEEKS, 6 DAYS WHEN A CERVICOVAGINAL 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 GESTATION. THE POSITIVE PREDICTIVE VALUE RANGES FROM 13.3% TO 31.7% FOR DELIVERY IN < 34 WEEKS, 6 DAYS AND REPRESENTS

510(k) clearances by this applicant