At-Home HPV Kit Shows How FDA Splits Test Oversight Between 510(k) and PMA

Waters Corporation said on April 8 that the Food and Drug Administration has cleared the Onclarity HPV Self-Collection Kit and approved the BD Onclarity HPV Assay with extended genotyping for at-home use. In the company's release, distributed by PR Newswire, Waters said the kit can be mailed to a patient's home, used to collect a sample and mailed back to a laboratory, with results shared with the patient's health care provider. The company said the kit is expected to be available by prescription in the coming months.

One announcement, two verbs: the kit was cleared and the assay was approved. The difference shows how FDA divides oversight of a single testing service between two premarket pathways.

Tests are devices, sorted by risk

FDA's overview of in vitro diagnostic regulation says reagents, instruments and systems used to diagnose disease, including products used to collect, prepare and examine specimens taken from the body, are devices under the Federal Food, Drug, and Cosmetic Act. Like other devices, they are placed in class I, II or III according to the level of control needed to reasonably assure safety and effectiveness, and the class determines the premarket process.

Most class II tests reach the market through a 510(k), a submission showing that a device is substantially equivalent to one already legally marketed. For a test, FDA says that review compares analytical performance with the predicate, including bias, imprecision and analytical specificity and sensitivity. The agency says it rarely requires prospective clinical studies for tests but regularly asks for well-characterized clinical samples.

Class III devices go through premarket approval, or PMA, FDA's review of safety and effectiveness for the highest-risk products. For tests, the same overview says, safety is not generally about contact with the patient; it "relates to the impact of the device's performance, and in particular on the impact of false negative and false positive results, on patient health."

Where the Onclarity pieces sit

FDA's 510(k) database entry lists the Onclarity Self-Collection Kit under K260184, with Becton, Dickinson and Company as applicant. The agency received the traditional 510(k) on January 21 and found the kit substantially equivalent on April 2. The record cites a clinical study, NCT06498661; Waters said it worked with the National Cancer Institute on that self-collection study, the SHIP trial.

The kit's product code, SEP, is class II under 21 CFR 866.2920. FDA defines it as a device for lay users at home to collect and transport vaginal specimens "for testing using an approved HPV molecular assay with which the device has been validated." The collection device is cleared on its own, but only for use with an approved assay, so the assay keeps its own premarket approval.

Waters' release says BD is still the legal manufacturer of the products, and keeps responsibility for their regulatory obligations, until regulatory transfers following Waters' purchase of BD's diagnostics business are completed.

What else applies to a lab test

Premarket review is only one layer. All tests are subject to general controls, which FDA lists as covering adulteration, misbranding, registration and listing, records and reports, and good manufacturing practices. Tests also carry labeling rules in 21 CFR 809, and FDA points makers of home-use tests to separate labeling considerations.

Because the home sample is analyzed in a laboratory, a second law also applies. The Clinical Laboratory Improvement Amendments of 1988, known as CLIA, set quality standards for laboratory testing, with requirements that rise from waived tests to moderate and high complexity, FDA's overview says. Makers apply for a CLIA category during the premarket process, and laboratories running moderate or high complexity tests face standards on personnel, proficiency testing, quality control and inspections.