Approval for a rapid, qualitative test for detecting the presence of fetal fibronective (ffn) in cerviocovaginal secretions. The device, as modified, will be marketed under the trade name fetal fibronectin rapid system and is indicated as an aid to rapidly assess the risk of preterm delivery in
| Device | ADEZA FETAL FIBRONECTIN EIK |
| Classification Name | Enzyme Immunoassay, Fetal Fibronectin |
| Generic Name | Enzyme Immunoassay, Fetal Fibronectin |
| Applicant | HOLOGIC, INC. |
| Date Received | 1998-02-13 |
| Decision Date | 1998-08-14 |
| PMA | P920048 |
| Supplement | S002 |
| Product Code | LKV |
| Advisory Committee | Clinical Chemistry |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | Yes |
| Combination Product | No |
| Applicant Address | HOLOGIC, INC. 1240 Elko Drive sunnyvale, CA 94089 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P920048 | | Original 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