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.
| Device | RAPID FFN FOR THE TLIIQ SYSTEM |
| Classification Name | Enzyme Immunoassay, Fetal Fibronectin |
| Generic Name | Enzyme Immunoassay, Fetal Fibronectin |
| Applicant | HOLOGIC, INC. |
| Date Received | 2015-04-09 |
| Decision Date | 2015-06-24 |
| PMA | P920048 |
| Supplement | S009 |
| Product Code | LKV |
| Advisory Committee | Clinical Chemistry |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| 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