---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-26-041901"
form_type: "8-K"
ticker: "INBS"
cik: "0001725430"
company_name: "INTELLIGENT BIO SOLUTIONS INC."
filed_at: "2026-09-09T12:50:25+00:00"
generated_at: "2026-09-09T12:55:06.446211+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Intelligent Bio Solutions files FDA 510(k) for fingerprint drug screening codeine detection

## Summary
- Submitted 510(k) to FDA on Sept 9, 2026 seeking clearance for opiate codeine detection via fingerprint sweat analysis.
- Method Comparison Study: accuracy >98%, sensitivity >94%, specificity 100%, verified by LC-MS/MS across 3 U.S. clinical sites.
- Package includes 18 test reports, 170+ attachments, 15,000+ data lines from 18,000+ hours of data collection.
- Precision testing: 1,600+ tests across 3 production runs and 3 sites; cut-off study in 40 adults vs FDA-cleared predicate.
- Cybersecurity: 100% of medium-risk vulnerabilities remediated; all 19 SBOM vulnerabilities resolved with third-party verification.

## SEC filing metadata
- accession: 0001493152-26-041901
- form_type: 8-K
- ticker: INBS
- cik: 0001725430
- company_name: INTELLIGENT BIO SOLUTIONS INC.
- filed_at: 2026-09-09T12:50:25+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1725430/000149315226041901/0001493152-26-041901-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1725430/000149315226041901/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-26-041901
- JSON: https://secwatch.observer/filing/0001493152-26-041901.json
- Plain text: https://secwatch.observer/filing/0001493152-26-041901.txt

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