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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.
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.
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.
De Novo granted (DEN240045) source
| Region | Year | Indication |
|---|---|---|
| US | 2025 | Home collection and transport of vaginal specimens by lay users for an approved HPV assay (De Novo DEN240045) |
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Query for this drug: (TITLE:"Teal Wand" OR ABSTRACT:"Teal Wand" OR TITLE:"home self-collection for HPV screening" OR ABSTRACT:"home self-collection for HPV screening") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Teal Wand (home self-collection for HPV screening), not a curated reading list.
Shares BD Onclarity HPV Assay (extended genotyping), cobas HPV test (Roche), FDA medical device databases (PMA, 510(k), De Novo), HPV DNA testing and self-sampling and the tags test, screening-test.
Shares cobas HPV test (Roche), FDA medical device databases (PMA, 510(k), De Novo), HPV DNA testing and self-sampling, Screening and the tags test, screening-test.
Shares cobas HPV test (Roche), FDA medical device databases (PMA, 510(k), De Novo), HPV DNA testing and self-sampling, Screening and the tags test, screening-test.
Shares cobas HPV test (Roche), FDA medical device databases (PMA, 510(k), De Novo), HPV DNA testing and self-sampling, Screening and the tags test, screening-test.
Shares BD Onclarity HPV Assay (extended genotyping), FDA medical device databases (PMA, 510(k), De Novo), HPV DNA testing and self-sampling, Screening and the tags test, screening-test.
Shares FDA medical device databases (PMA, 510(k), De Novo), Screening and the tags test, screening-test.
Shares FDA medical device databases (PMA, 510(k), De Novo), Screening and the tags test, screening-test.
Shares FDA medical device databases (PMA, 510(k), De Novo), HPV DNA testing and self-sampling, Screening and the tags test, screening-test.
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