---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-26-034018"
form_type: "8-K"
ticker: "INBS"
cik: "0001725430"
company_name: "INTELLIGENT BIO SOLUTIONS INC."
filed_at: "2026-07-21T12:50:36+00:00"
generated_at: "2026-07-21T12:55:08.829642+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 precision testing for FDA 510(k) submission for codeine detection

## Summary
- Precision testing included over 1,600 tests across three production runs and three independent sites.
- Results confirmed repeatable, reproducible performance, strengthening the FDA 510(k) submission package.
- Submission targets U.S. market clearance for the Intelligent Fingerprinting Drug Screening System for opiate codeine.
- Company plans U.S. launch after FDA 510(k) clearance, citing a multi-billion-dollar annual drug screening market.
- CEO Harry Simeonidis stated the testing puts the company firmly on track for submission and launch.

## SEC filing metadata
- accession: 0001493152-26-034018
- form_type: 8-K
- ticker: INBS
- cik: 0001725430
- company_name: INTELLIGENT BIO SOLUTIONS INC.
- filed_at: 2026-07-21T12:50:36+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/1725430/000149315226034018/0001493152-26-034018-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1725430/000149315226034018/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-26-034018
- JSON: https://secwatch.observer/filing/0001493152-26-034018.json
- Plain text: https://secwatch.observer/filing/0001493152-26-034018.txt

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