{"schema_version":"secwatch.filing_event.v1","accession":"0001116463-26-000002","form_type":"8-K","ticker":"OSUR","cik":"0001116463","company_name":"ORASURE TECHNOLOGIES INC","filed_at":"2026-01-05T23:59:59+00:00","discovered_at":"2026-05-14T18:02:34.559393+00:00","generated_at":"2026-05-16T11:37:52.184732+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"OraSure submits two FDA applications for rapid CT/NG self-test and at-home urine collection device","bullets":["Submitted two FDA 510(k) applications: one for a rapid molecular self-test for Chlamydia and Gonorrhea (CT/NG) and one for the Colli-Pee at-home urine collection device for STI indications.","Rapid CT/NG self-test is designed to deliver results in approximately 30 minutes in a disposable, over-the-counter format.","Colli-Pee device is intended for at-home urine collection, including for multiple STI indications.","No timeline for FDA clearance; approval would open new OTC market for OraSure in sexual health diagnostics."],"urls":{"canonical":"https://secwatch.observer/filing/0001116463-26-000002","json":"https://secwatch.observer/filing/0001116463-26-000002.json","markdown":"https://secwatch.observer/filing/0001116463-26-000002.md","text":"https://secwatch.observer/filing/0001116463-26-000002.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1116463/000111646326000002/0001116463-26-000002-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1116463/000111646326000002/osur-20260105.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T11:37:52.184732+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}