Identity
- Trade Name
- Alinity m HR HPV FDA PMA
- Generic Name
- KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS FDA PMA
Identifiers
- PMA Number
- P230003 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
Alinity m HR HPV is a qualitative in vitro test for the detection of Human Papillomavirus DNA in cervical specimens collected by a health care professional using an endocervical brush/spatula placed in ThinPrep PreservCyt Solution or an endocervical broom placed in SurePath Preservative Fluid. This test identifies high-risk (HR) HPV types 16, 18, 45, while reporting the concurrent detection of the other HR genotypes (31/33/52/58) and (35/39/51/56/59/66/68).
Alinity m HR HPV is indicated for use in routine cervical cancer screening as per professional medical guidelines, including triage of ASC-US cytology, co-testing (adjunctive screening) with cytology, and HPV primary screening of women to assess the risk for cervical pre-cancer and cancer. Patients should be followed-up in accordance with professional medical guidelines, results from prior screening, medical history, and other risk factors.
Frequently asked questions
What HPV types does the Alinity m HR HPV test detect?
The Alinity m HR HPV test identifies high-risk HPV types 16, 18, and 45, while also reporting the concurrent detection of other high-risk genotypes: (31/33/52/58) and (35/39/51/56/59/66/68).
What type of specimens can be used with the Alinity m HR HPV test?
The test uses cervical specimens collected by a health care professional using an endocervical brush/spatula placed in ThinPrep PreservCyt Solution or an endocervical broom placed in SurePath Preservative Fluid.
Is the Alinity m HR HPV test intended for primary HPV screening?
Yes, the test is indicated for HPV primary screening of women to assess the risk for cervical pre-cancer and cancer, as well as for triage of ASC-US cytology and co-testing with cytology, in accordance with professional medical guidelines.
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. Sources consulted: Alinity | Core Laboratory bei Abbott, Alinity | Core Laboratory at Abbott, Alinity n - transfusion.abbott
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P230003 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Abbott Molecular, Inc.
Sources (1)
- FDA PMA P230003 24 fields · synced Sep 18, 2026