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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 Drive
Sunnyvale, CA 94089
PMA NumberP920048
Supplement NumberS001
Date Received06/26/1996
Decision Date01/08/1997
Product Code LKV 
Advisory Committee Clinical Chemistry
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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."
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