{"entity":{"id":"teal-wand","kind":"drug","name":"Teal Wand (home self-collection for HPV screening)","aka":[],"tldr":"The first device the FDA authorised (May 2025) for women to collect their own sample for cervical cancer screening at home, without a clinic visit.","summary":"The FDA granted De Novo DEN240045 to Teal Health, Inc. (San Francisco) for the Teal Wand on 9 May 2025, creating the classification \"device for home collection and transport of vaginal specimens by lay users for use in an approved HPV molecular assay\" (product code SEP, 21 CFR 866.2920, class II). The FDA's definition of the type: a device \"intended for use by lay users in home settings or similar environments for the collection and transportation of vaginal specimens for testing using an approved HPV molecular assay with which the device has been validated\". Which HPV assay is validated with it is stated in the De Novo decision summary, which was not read for this record.","status":"approved","asOf":"2026-11-04","links":[{"label":"FDA De Novo DEN240045","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN240045"}],"tags":["test","screening-test"],"related":["cobas-hpv","bd-onclarity-hpv","fda-device-databases"],"cancers":[],"sections":["early-detection","diagnostics"],"technologies":["hpv-testing"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["screening"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["What a result means: a positive HPV test means a high-risk virus type was found, not that there is a precancer or cancer; it leads to triage (genotyping, cytology or a dual stain) or colposcopy according to the screening programme's guideline."],"brand":"Teal Wand","modality":"Home vaginal self-collection device for HPV testing","mechanism":"A device a woman uses at home to collect a vaginal sample and send it to a laboratory, where it is tested with an approved HPV assay validated for that device.","approvals":[{"region":"US","year":2025,"indication":"Home collection and transport of vaginal specimens by lay users for an approved HPV assay (De Novo DEN240045)"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[{"date":"2025-05-09","type":"approval","region":"US","note":"De Novo granted (DEN240045)","source":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN240045"}]},"route":"/drugs/teal-wand/","neighbours":{"drug":[{"id":"bd-onclarity-hpv","kind":"drug","name":"BD Onclarity HPV Assay (extended genotyping)","route":"/drugs/bd-onclarity-hpv/"},{"id":"cobas-hpv","kind":"drug","name":"cobas HPV test (Roche)","route":"/drugs/cobas-hpv/"}],"collection":[{"id":"fda-device-databases","kind":"collection","name":"FDA medical device databases (PMA, 510(k), De Novo)","route":"/collections/fda-device-databases/"}],"section":[{"id":"diagnostics","kind":"section","name":"Diagnostics & Biomarkers","route":"/fronts/diagnostics/"},{"id":"early-detection","kind":"section","name":"Early Detection & Screening","route":"/fronts/early-detection/"}],"technology":[{"id":"hpv-testing","kind":"technology","name":"HPV DNA testing and self-sampling","route":"/technologies/hpv-testing/"}],"term":[{"id":"screening","kind":"term","name":"Screening","route":"/terms/screening/"}]}}