- Device
- cobas HBV
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P150014
- Supplement
- S058
- Product code
- MKT
- Generic name
- Hepatitis Viral B DNA Detection
- Decision date
- 2025-09-19
- Decision code
- APPR
- Date received
- 2025-08-22
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- cobas HPV for use on the cobas 5800/6800/8800 Systems (cobas HPV) is a qualitative in vitro test for the detection of high-risk Human Papillomavirus. This test detects the high-risk HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68 in the specimens listed below. Clinician-collected cervical specimens should be obtained using an endocervical brush/spatula or broom and placed in the ThinPrep Pap Test PreservCyt Solution. Self-collected vaginal specimens, obtained in a healthcare setting, can be tested as an alternative specimen type when cervical sampling is either contraindicated or cervical samples otherwise cannot be obtained. 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 individuals with a cervix 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