Rapid fFN for the TLiIQ System

FDA Premarket Approval P920048 S021

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.

Pre-market Approval Supplement Details

DeviceRapid fFN for the TLiIQ System
Generic NameEnzyme Immunoassay, Fetal Fibronectin
ApplicantHOLOGIC, INC.1240 Elko Drivesunnyvale, CA 94089 PMA NumberP920048 Supplement NumberS021 Date Received02/14/2022 Decision Date02/28/2022 Product Code LKV  Advisory Committee Toxicology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-02-14
Decision Date2022-02-28
PMAP920048
SupplementS021
Product CodeLKV 
Advisory CommitteeToxicology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressHOLOGIC, INC.
1240 Elko Drive
sunnyvale, CA 94089 PMA NumberP920048 Supplement NumberS021 Date Received02/14/2022 Decision Date02/28/2022 Product Code LKV  Advisory Committee Toxicology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
the Move Of A Supplier’s Manufacturing Facility For A Critical Raw Material (i.e., Ascites Fluid Containing A137 Mouse Monoclonal Antibodies) Of The Rapid FFN For The TLiIQ System

Supplemental Filings

Supplement NumberDateSupplement Type
P920048Original Filing
S023 2022-04-29 30-day Notice
S022 2022-03-31 30-day Notice
S021 2022-02-14 30-day Notice
S020 2021-04-09 30-day Notice
S019
S018 2020-09-08 30-day Notice
S017 2020-07-10 30-day Notice
S016
S015
S014 2018-11-20 30-day Notice
S013
S012
S011 2015-06-10 Real-time Process
S010
S009 2015-04-09 Real-time Process
S008 2014-06-24 30-day Notice
S007
S006 2008-09-29 30-day Notice
S005 2007-12-21 Normal 180 Day Track No User Fee
S004
S003 2000-09-11 Normal 180 Day Track
S002 1998-02-13 Normal 180 Day Track
S001 1996-06-26 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
25420045500874 P920048 001
15420045500877 P920048 001
15420045500884 P920048 001
15420045501164 P920048 001
15420045501171 P920048 001
25420045501154 P920048 001
15420045500877 P920048 006
15420045500884 P920048 006
15420045501164 P920048 008
15420045501171 P920048 008
15420045505346 P920048 009

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