Approval for use of a modified surepath vial for collection of specimens to be tested with the onclarity hpv assay, and the automated transfer of pre- and post- cytology aliquots using the bd totalys multiprocessor for testing with the bd onclarity assay.
| Device | Onclarity HPV Assay |
| Classification Name | Kit, Dna Detection, Human Papillomavirus |
| Generic Name | Kit, Dna Detection, Human Papillomavirus |
| Applicant | BECTON, DICKINSON AND COMPANY |
| Date Received | 2019-02-26 |
| Decision Date | 2019-05-13 |
| PMA | P160037 |
| Supplement | S002 |
| Product Code | MAQ |
| Advisory Committee | Microbiology |
| Supplement Type | Real-time Process |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BECTON, DICKINSON AND COMPANY 7 Loveton Circle sparks, MD 21152 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P160037 | | Original Filing |
| S013 |
2022-11-21 |
30-day Notice |
| S012 | | |
| S011 |
2022-10-21 |
30-day Notice |
| S010 |
2021-10-28 |
Real-time Process |
| S009 |
2020-09-14 |
30-day Notice |
| S008 | | |
| S007 |
2020-07-06 |
30-day Notice |
| S006 |
2020-02-21 |
30-day Notice |
| S005 | | |
| S004 | | |
| S003 |
2019-08-21 |
Normal 180 Day Track No User Fee |
| S002 |
2019-02-26 |
Real-time Process |
| S001 |
2018-04-27 |
135 Review Track For 30-day Notice |
NIH GUDID Devices