secwatch.observer — SEC 8-K summary
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Issuer:     INTELLIGENT BIO SOLUTIONS INC. (INBS)
CIK:        0001725430
Form:       8-K
Filed at:   2026-08-11T21:29:49+00:00
Accession:  0001493152-26-037206
Event type: regulatory
Sentiment:  positive
Materiality: 0.60
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Intelligent Bio Solutions completes final clinical study; FDA 510(k) submission on track for H2 2026
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- 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.'

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1725430/000149315226037206/0001493152-26-037206-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1725430/000149315226037206/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-26-037206

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer