Approval for the cobas hpv for use on the cobas 6800/8800 systems. Cobas hpv for use on the cobas 6800/8800 systems (cobas hpv) is a qualitative in vitro test for the detection of human papillomavirus in clinician-collected cervical specimens using an endocervical brush/spatula or broom and placed in the thinprep pap test preservcyt solution. This test detects the high-risk hpv types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68. Cobas hpv is indicated for use for routine cervical cancer screening as per professional medical guidelines, including triage of asc-us cytology, co-testing (or adjunctive screen) with cytology, and hpv primary screening of women to assess the risk for cervical precancer and cancer. Patients should be followed-up in accordance with professional medical guidelines, results from prior screening, medical history, and other risk factors.
| Device | cobas HPV for use on the cobas 6800/8800 Systems |
| Generic Name | Kit, Dna Detection, Human Papillomavirus |
| Applicant | Roche Molecular Systems, Inc. |
| Date Received | 2019-10-07 |
| Decision Date | 2020-04-03 |
| PMA | P190028 |
| Supplement | S |
| Product Code | MAQ |
| Advisory Committee | Microbiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Roche Molecular Systems, Inc. 4300 Hacienda Drive pleasanton, CA 94588 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P190028 | Original Filing | |
| S006 | 2021-12-20 | 30-day Notice |
| S005 | 2021-05-18 | Special (immediate Track) |
| S004 | 2020-11-13 | 30-day Notice |
| S003 | 2020-09-17 | Special (immediate Track) |
| S002 | 2020-07-27 | 30-day Notice |
| S001 | 2020-04-10 | 30-day Notice |