{"schema_version":"secwatch.filing_event.v1","accession":"0001493152-26-037206","form_type":"8-K","ticker":"INBS","cik":"0001725430","company_name":"INTELLIGENT BIO SOLUTIONS INC.","filed_at":"2026-08-11T21:29:49+00:00","discovered_at":"2026-08-11T21:32:02.168117+00:00","generated_at":"2026-08-11T21:32:15.696490+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"Intelligent Bio Solutions completes final clinical study; FDA 510(k) submission on track for H2 2026","bullets":["Completed multi-site Method Comparison Study; all clinical data collection for FDA 510(k) program now complete.","Study ran at 3 U.S. clinical sites over 3 weeks with CenExel; 135 participants and 9 operators enrolled.","Data analysis underway; all specimens independently verified via LC-MS/MS analysis.","FDA 510(k) submission targeted for H2 2026 for opiate codeine detection, ahead of planned U.S. market entry.","CEO Harry Simeonidis: milestone represents 'a substantial body of work and clinical evidence.'"],"urls":{"canonical":"https://secwatch.observer/filing/0001493152-26-037206","json":"https://secwatch.observer/filing/0001493152-26-037206.json","markdown":"https://secwatch.observer/filing/0001493152-26-037206.md","text":"https://secwatch.observer/filing/0001493152-26-037206.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1725430/000149315226037206/0001493152-26-037206-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1725430/000149315226037206/form8-k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-08-11T21:32:15.696490+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"}