{"schema_version":"secwatch.filing_event.v1","accession":"0001493152-26-041901","form_type":"8-K","ticker":"INBS","cik":"0001725430","company_name":"INTELLIGENT BIO SOLUTIONS INC.","filed_at":"2026-09-09T12:50:25+00:00","discovered_at":"2026-09-09T12:55:00.917781+00:00","generated_at":"2026-09-09T12:55:06.446211+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Intelligent Bio Solutions files FDA 510(k) for fingerprint drug screening codeine detection","bullets":["Submitted 510(k) to FDA on Sept 9, 2026 seeking clearance for opiate codeine detection via fingerprint sweat analysis.","Method Comparison Study: accuracy >98%, sensitivity >94%, specificity 100%, verified by LC-MS/MS across 3 U.S. clinical sites.","Package includes 18 test reports, 170+ attachments, 15,000+ data lines from 18,000+ hours of data collection.","Precision testing: 1,600+ tests across 3 production runs and 3 sites; cut-off study in 40 adults vs FDA-cleared predicate.","Cybersecurity: 100% of medium-risk vulnerabilities remediated; all 19 SBOM vulnerabilities resolved with third-party verification."],"urls":{"canonical":"https://secwatch.observer/filing/0001493152-26-041901","json":"https://secwatch.observer/filing/0001493152-26-041901.json","markdown":"https://secwatch.observer/filing/0001493152-26-041901.md","text":"https://secwatch.observer/filing/0001493152-26-041901.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1725430/000149315226041901/0001493152-26-041901-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1725430/000149315226041901/form8-k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-09-09T12:55:06.446211+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"}