| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | cobas HPV for use on the cobas 6800/8800 Systems |
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| Generic Name | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS |
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| Applicant | Roche Molecular Systems, Inc.
4300 Hacienda Drive
Pleasanton, CA 94588 |
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| PMA Number | P190028 |
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| Date Received | 10/07/2019 |
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| Decision Date | 04/03/2020 |
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| Product Code |
MAQ |
| Docket Number | 20M-1213 |
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| Notice Date | 04/07/2020 |
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| Advisory Committee |
Microbiology |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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Approval Order Statement
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. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
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| Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S010 S011 S012
S013 S014 |
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