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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.
 
DeviceRAPID FFN CONTROL KIT
Generic NameENZYME IMMUNOASSAY, FETAL FIBRONECTIN
ApplicantHologic, Inc.
1240 Elko Dr.
Sunnyvale, CA 94089
PMA NumberP920048
Supplement NumberS008
Date Received06/24/2014
Decision Date07/24/2014
Product Code LKV 
Advisory Committee Clinical Chemistry
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE TO ADD AN INTERMEDIATE SOLUTION IN THE MANUFACTURING PROCESS OF POSITIVE REFERENCE CALIBRATOR, TO MODIFY THE PERSONNEL IN CHARGE OF IN-PROCESS MANUFACTURING TESTING AND TO INCREASE THE NUMBER OF REPLICATES IN BULK SOLUTION CONCENTRATION VERIFICATION PROCEDURE FOR BOTH POSITIVE REFERENCE CALIBRATOR AND POSITIVE CONTROL. THE POSITIVE REFERENCECALIBRATOR AND THE POSITIVE CONTROL ARE COMPONENTS OF THE RAPID FFN CONTROL KIT FOR USE WITH THE TLIIQ ANALYZER AND FFN ELISA TEST.
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