PMA P920048S001

Device: ADEZA FETAL FIBRONECTIN EIK
Applicant: Hologic, Inc.
PMA number: P920048
Supplement: S001
Product code: LKV
Decision date: 1997-01-08
Classification: Enzyme Immunoassay, Fetal Fibronectin
Generic name: ENZYME IMMUNOASSAY, FETAL FIBRONECTIN
Approval order 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 AN APPROXIMATE 4- TO 7-FOLD INCREASE IN RISK OVER THE RELIABILITY OF PREDICTING DELIVERY GIVEN NO TEST INFO. THE NEGATIVE PREDICTIVE VALUE RANGES FROM 96.4% TO 97.9% MAKING IT HIGHLY LIKELY THAT DELIVERY WILL NOT OCCUR IN THESE TIME FRAMES."

Current openFDA PMA Record#

Device: ADEZA FETAL FIBRONECTIN EIK
Applicant: Hologic, Inc.
PMA number: P920048
Supplement: S001
Product code: LKV
Generic name: ENZYME IMMUNOASSAY, FETAL FIBRONECTIN
Decision date: 1997-01-08
Decision code: APPR
Date received: 1996-06-26
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order 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 AN APPROXIMATE 4- TO 7-FOLD INCREASE IN RISK OVER THE RELIABILITY OF PREDICTING DELIVERY GIVEN NO TEST INFO. THE NEGATIVE PREDICTIVE VALUE RANGES FROM 96.4% TO 97.9% MAKING IT HIGHLY LIKELY THAT DELIVERY WILL NOT OCCUR IN THESE TIME FRAMES."