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  1. Recently-Approved Devices

BD Onclarity HPV Assay – P160037/S017

 

The BD Onclarity HPV Assay is a laboratory test used with the BD Viper LT and BD COR Systems for the detection of human papillomavirus (HPV).


This is a brief overview of information related to the FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for the FDA’s approval. 

Product Name: BD Onclarity HPV Assay
PMA Applicant: Becton, Dickinson and Company
Address: 7 Loveton Circle, Sparks, MD 21152
Approval Date: May 14, 2024
Approval Letter: Approval Order

What is it?

The BD Onclarity HPV Assay is a laboratory test used with the BD Viper LTExternal Link Disclaimer and BD COR SystemsExternal Link Disclaimer for the detection of human papillomavirus (HPV). This test detects DNA from 14 high risk human papillomavirus (HR HPV) types that are associated with cervical cancer. The test specifically identifies HPV genotypes 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).

Samples (specimens) containing cervical cells are collected during a Pap test and loaded onto the BD Viper LT and BD COR System. Self-collected vaginal specimens, obtained in a healthcare setting and loaded onto the BD Viper LT or BD COR System, can also be tested when cervical specimens are not available. DNA is then separated from those cells, and the device determines the presence or absence of high-risk HPV DNA.

This test is used during routine cervical cancer screening after a healthcare provider has ordered an HPV test to collect information regarding a patient’s risk for cervical cancer. The test is used in conjunction with a healthcare provider’s assessment and professional guidelines, to guide patient management.

Test results can provide information regarding a patient’s risk for developing cervical cancer. A negative test result is useful in ruling out a potentially cancer-causing infection. A positive result can guide different follow-up procedures for the patient depending on which HPV type is detected.

The BD Onclarity HPV Assay should not be used:

  • For determining the need for treatment, such as cutting (excisional) or using a laser (ablative) treatment of the cervix, in the absence of cervical dysplasia.
  • For patients who have undergone a hysterectomy.
  • With specimens other than those collected by a clinician by lightly scraping or brushing off the cervix and being placed into a BD SurePath Collection Vial or ThinPrep PreservCyt Solution Vial.
  • With self-collected vaginal specimens obtained with collection devices not cleared for use with this test.

The use of this test has not been evaluated for women with prior ablative or excisional therapy, or who are pregnant.

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