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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 FOR THE TLIIQ SYSTEM
Generic NameENZYME IMMUNOASSAY, FETAL FIBRONECTIN
ApplicantHologic, Inc.
1240 Elko Dr.
Sunnyvale, CA 94089
PMA NumberP920048
Supplement NumberS009
Date Received04/09/2015
Decision Date06/24/2015
Product Code LKV 
Advisory Committee Clinical Chemistry
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE USE OF A NEW RESIN IN THE PLASMA FIBRONECTIN (PFN) AFFINITY COLUMN USED TO PURIFY THE A120 FETAL FIBRONECTIN SPECIFIC ANTIBODY CONTAINED IN THE RAPID FFN TEST FOR THE TLIIQ SYSTEM. ADDITIONALLY, THE IMPLEMENTATION OF A MODIFIED ARGININE CONTAINING NEUTRALIZATION BUFFER TO DECREASE PRECIPITATION OF THE A120 ANTIBODY FROM THE BUFFER.
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