COBAS HPV TEST
FDA premarket approval P100020 · decided 2011-04-19
Approval details
- PMA number
- P100020
- Trade name
- COBAS HPV TEST
- Generic name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
- Applicant
- Roche Molecular Systems, Inc.
- Date received
- 2010-06-01
- Decision date
- 2011-04-19
- Days to decision
- 322 days
- Decision code
- APPR
- Product code
- MAQ
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- APPROVAL FOR THE COBAS HPV TEST. COBAS HPV TEST INDICATIONS FOR USE: THE COBAS HPV TEST IS A QUALITATIVE IN VITRO TEST FOR THE DETECTION OF HUMAN PAPILLOMAVIRUS (HPV) IN PATIENT SPECIMENS. THE TEST UTILIZES AMPLIFICATION OF TARGET DNA BY THE POLYMERASE CHAIN REACTION (PCR) AND NUCLEIC ACID HYBRIDIZATION FOR THE DETECTION OF 14 HIGH-RISK (HR) HPV TYPES IN A SINGLE ANALYSIS. THE TEST SPECIFICALLY IDENTIFIES TYPES HPV 16 AND HPV 18 WHILE CONCURRENTLY DETECTING THE REST OF THE REST OF THE HIGH RISK
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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 |