---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-26-036112"
form_type: "8-K"
ticker: "INBS"
cik: "0001725430"
company_name: "INTELLIGENT BIO SOLUTIONS INC."
filed_at: "2026-08-05T12:55:18+00:00"
generated_at: "2026-08-05T13:00:23.889933+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 usability study for FDA 510(k) submission for drug screening system

## Summary
- Study confirms system can be effectively administered by operators with no specialist background.
- Study conducted with CenExel Clinical Research; 15 operators participated.
- On track to submit 510(k) package in H2 2026 for U.S. market clearance for opiate codeine detection.
- Part of broader submission program including cut-off, method comparison, interference, and precision studies.
- Targets entry into the multi-billion-dollar U.S. drug screening market.

## SEC filing metadata
- accession: 0001493152-26-036112
- form_type: 8-K
- ticker: INBS
- cik: 0001725430
- company_name: INTELLIGENT BIO SOLUTIONS INC.
- filed_at: 2026-08-05T12:55:18+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/1725430/000149315226036112/0001493152-26-036112-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1725430/000149315226036112/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-26-036112
- JSON: https://secwatch.observer/filing/0001493152-26-036112.json
- Plain text: https://secwatch.observer/filing/0001493152-26-036112.txt

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