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.
| Device | RAPID FFN CONTROL KIT |
| Classification Name | Enzyme Immunoassay, Fetal Fibronectin |
| Generic Name | Enzyme Immunoassay, Fetal Fibronectin |
| Applicant | HOLOGIC, INC. |
| Date Received | 2014-06-24 |
| Decision Date | 2014-07-24 |
| PMA | P920048 |
| Supplement | S008 |
| Product Code | LKV |
| Advisory Committee | Clinical Chemistry |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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