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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
DeviceBD Onclarity HPV Assay
Generic Namekit, dna detection, human papillomavirus
7 loveton circle
sparks, MD 21152
PMA NumberP160037
Supplement NumberS004
Date Received11/07/2019
Decision Date06/12/2020
Product Code MAQ 
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to labeling to include expansion of the assay reporting claims to include additional high-risk HPV genotypes (beyond HPV 16, 18 and 45). The BD Onclarity HPV Assay is a qualitative in vitro test for the detection of Human Papillomavirus in clinician-collected cervical specimens using an endocervical brush/spatula combination or broom and placed in a BD SurePath vial. 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 16, 18, 31, 45, 51, and 52 while reporting the other HR HPV types in groups (33/58, 35/39/68, and 56/59/66). The BD Onclarity HPV Assay is indicated for use for routine cervical cancer screening as per professional medical guidelines, including triage of ASC-US cytology, co-testing (or adjunctive screen) with cytology, and HPV primary screening of women to assess the risk for cervical precancer and cancer. Patients should be followed-up in accordance with professional medical guidelines, results from prior screening, medical history, and other risk factors.WARNINGThe BD Onclarity HPV Assay is NOT intended:1) For use in determining the need for treatment (i.e., excisional or ablative treatment of the cervix) in the absence of high-grade cervical dysplasia. Patients who are HPV 16, 18 and 45 positive should be assessed for the development of high-grade cervical intraepithelial neoplasia according to current practice guidelines;2) For women who have undergone hysterectomy with removal of the cervix; and3) For use with samples other than those collected by a clinician using an endocervical brush/spatula combination or broom and placed in the BD SurePath Preservative Fluid Collection Vial.HPV-negative cancers of the cervix do occur infrequently. No cancer screening test is 100% sensitive. Use of this device for primary cervical cancer screening should be undertaken after carefully considering the performance characteristics put forth in this label, as well as recommendations of professional guidelines.The use of this test has not been evaluated for the management of women with prior ablative or excisional therapy, or who are pregnant, or below age 21, or for the management of transgender individuals.