Identity
- Trade Name
- COBAS HPV TEST FDA PMA
- Generic Name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS FDA PMA
Identifiers
- PMA Number
- P100020 FDA PMA
- FDA Product Code
- MAQ FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Microbiology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The cobas HPV Test is a qualitative in vitro diagnostic device classified as a DNA detection kit for human papillomavirus (HPV). It employs polymerase chain reaction (PCR) amplification and nucleic acid hybridization to detect 14 high-risk HPV types in a single analysis, specifically identifying HPV types 16 and 18 alongside types 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68.
This test is intended for use in patients aged 21 years and older with atypical squamous cells of undetermined significance (ASC-US) cytology results to determine referral to colposcopy or assess the presence or absence of high-risk HPV genotypes. For women aged 30 years and older, it may be used adjunctively with cervical cytology for screening or to evaluate HPV types 16 and 18. Supplied as a kit, the device operates in clinical laboratory settings and is approved under FDA PMA (P100020). No sterility or MRI safety information is provided.
Frequently asked questions
What age groups is the cobas HPV Test authorized for use in, and what specific clinical scenarios does it address?
The cobas HPV Test is authorized for use in patients aged 21 years and older. It is primarily intended for patients with ASC-US (atypical squamous cells of undetermined significance) cytology results to help determine whether referral to colposcopy is needed. For women aged 30 and older, it can be used alongside cervical cytology for screening or to specifically assess the presence or absence of high-risk HPV types 16 and 18, aiding in patient management decisions based on clinical guidelines.
How does the cobas HPV Test detect high-risk HPV types, and what types does it specifically identify?
The cobas HPV Test uses polymerase chain reaction (PCR) amplification and nucleic acid hybridization to detect 14 high-risk HPV types in a single test. It specifically identifies HPV types 16 and 18 individually while concurrently detecting the remaining high-risk types: 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68.
Is the cobas HPV Test intended for point-of-care use, or is it designed for laboratory settings?
The cobas HPV Test is supplied as a kit and is designed for use in clinical laboratory settings only. It is not intended for point-of-care or home-use applications, as it requires specialized equipment and trained personnel to perform the PCR-based analysis.
What is the regulatory pathway for the cobas HPV Test, and when was it approved?
The cobas HPV Test was approved under the FDA’s Premarket Approval (PMA) pathway with the PMA number P100020. The decision to approve was made on April 19, 2011, following a review by the FDA’s Microbiology (MI) Advisory Committee. The test is classified as a Class III device due to its high-risk nature.
Does the cobas HPV Test provide results that can stand alone to guide patient management, or must they be combined with other clinical factors?
The cobas HPV Test results are meant to be used alongside a physician’s assessment of cytology history, other risk factors, and professional guidelines to guide patient management. The test results alone are not intended to prevent women from proceeding to colposcopy or to make definitive management decisions without clinical correlation.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P100020 | Class III | Active |
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Manufacturer
- Manufacturer
- Roche Molecular Systems, Inc.
Sources (1)
- FDA PMA P100020 24 fields · synced Sep 18, 2026