Approval for a modification of the intended use statement as follows: "the device is further indicated for use in conjunction with other clinical info as an aid in assessing the risk of preterm delivery in < 34 weeks, 6 days when a cervicovaginal sample is obtained during a routine prenatal visit between 22 weeks, 0 days and 30 weeks, 6 days of gestation in women with a singleton gestation. The positive predictive value ranges from 13. 3% to 31. 7% for delivery in < 34 weeks, 6 days and represents an approximate 4- to 7-fold increase in risk over the reliability of predicting delivery given no test info. The negative predictive value ranges from 96. 4% to 97. 9% making it highly likely that delivery will not occur in these time frames. "
| Device | ADEZA FETAL FIBRONECTIN EIK |
| Classification Name | Enzyme Immunoassay, Fetal Fibronectin |
| Generic Name | Enzyme Immunoassay, Fetal Fibronectin |
| Applicant | HOLOGIC, INC. |
| Date Received | 1996-06-26 |
| Decision Date | 1997-01-08 |
| PMA | P920048 |
| Supplement | S001 |
| Product Code | LKV |
| Advisory Committee | Clinical Chemistry |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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