ROCHE COBAS HPV TEST
FDA premarket approval P100020/S004 · decided 2013-06-25
Approval details
- PMA number
- P100020
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ROCHE COBAS HPV TEST
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Applicant
- Roche Molecular Systems, Inc.
- Date received
- 2012-04-02
- Decision date
- 2013-06-25
- Days to decision
- 449 days
- Decision code
- APPR
- Product code
- MAQ
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- APPROVAL FOR PROCESSING OF RESIDUAL CERVICAL SAMPLE DIRECTLY FROM THE PRESERVCYT¿ VIAL (HOLOGIC, INC., BEDFORD, MA) AFTER PROCESSING FOR LIQUID-BASED CYTOLOGY (LBC) USING EITHER THE HOLOGIC THINPREP® 2000 OR THINPREP® 3000 PROCESSORS AND TESTING ON THE COBAS® 4800 SYSTEM DIRECTLY FROM THE PRESERVCYT VIAL (PRIMARY VIAL). APPROVAL FOR CAPABILITY TOADD OPTIONAL NON-IVD SOFTWARE TO THE COBAS® 4800 SYSTEM THAT IS USED TO PERFORM THE COBAS® HPV TEST WAS ALSO REQUESTED.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| cobas® BV/CV (K260021) | Roche Molecular Systems, Inc. | 2026-07-16 |
| cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systems (K260917) | Roche Molecular Systems, Inc. | 2026-07-08 |
| cobas liat CT/NG/MG nucleic acid test (K253759) | Roche Molecular Systems, Inc. | 2026-05-15 |
| cobas liat CT/NG nucleic acid test (K253756) | Roche Molecular Systems, Inc. | 2026-05-15 |
| cobas liat Bordetella panel nucleic acid test (K243753) | Roche Molecular Systems, Inc. | 2025-11-20 |
| cobas CMV (K252481) | Roche Molecular Systems, Inc. | 2025-11-03 |
| cobas HCV (K252484) | Roche Molecular Systems, Inc. | 2025-11-03 |
| cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems (K243455) | Roche Molecular Systems, Inc. | 2025-07-31 |