FDA.reportPublic FDA data

PMA P230003S006

Device
Alinity m HR HPV
Applicant
Abbott Molecular, Inc.
PMA number
P230003
Supplement
S006
Product code
MAQ
Decision date
2025-09-10
Classification
Microbiology
Generic name
KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
Approval order statement
Alinity m HR HPV is a qualitative in vitro test for the detection of Human Papillomavirus DNA. Cervical specimens should be collected by a health care professional using an endocervical collection brush/spatula placed in ThinPrep PreservCyt Solution or endocervical broom placed in SurePath Preservative Fluid.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 specimens otherwise cannot be obtained.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, andother risk factors.

Current openFDA PMA Record#

Device
Alinity m HR HPV
Applicant
Abbott Molecular, Inc.
PMA number
P230003
Supplement
S006
Product code
MAQ
Generic name
KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
Decision date
2025-09-10
Decision code
APPR
Date received
2024-12-20
Supplement type
Panel Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Alinity m HR HPV is a qualitative in vitro test for the detection of Human Papillomavirus DNA. Cervical specimens should be collected by a health care professional using an endocervical collection brush/spatula placed in ThinPrep PreservCyt Solution or endocervical broom placed in SurePath Preservative Fluid.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 specimens otherwise cannot be obtained.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, andother risk factors.