---
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"
generated_at: "2026-08-11T21:32:15.696490+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.'

## SEC filing metadata
- 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
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 7.01, 9.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-26-037206
- JSON: https://secwatch.observer/filing/0001493152-26-037206.json
- Plain text: https://secwatch.observer/filing/0001493152-26-037206.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.