---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-25-015068"
form_type: "8-K"
ticker: "INBS"
cik: "0001725430"
company_name: "INTELLIGENT BIO SOLUTIONS INC."
filed_at: "2025-09-26T23:59:59+00:00"
generated_at: "2026-05-17T05:34:34.113408+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.55
calibrated_materiality_score: 0.55
confidence: "high"
source: SEC EDGAR
---

# Intelligent Bio Solutions updates FDA 510(k) timeline; clearance expected H2 2026

## Summary
- Will commence clinical studies before year-end to gather additional data for FDA 510(k) resubmission for codeine fingerprint test.
- Anticipates FDA 510(k) clearance for opiate codeine use in the second half of 2026.
- Drug screening system adopted by over 450 accounts in 24 countries with 18 distribution partners.
- Currently marketed outside U.S. and for forensic use only; FDA clearance would open broader U.S. commercial entry.

## SEC filing metadata
- accession: 0001493152-25-015068
- form_type: 8-K
- ticker: INBS
- cik: 0001725430
- company_name: INTELLIGENT BIO SOLUTIONS INC.
- filed_at: 2025-09-26T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.55
- calibrated_materiality_score: 0.55
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1725430/000149315225015068/0001493152-25-015068-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1725430/000149315225015068/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-25-015068
- JSON: https://secwatch.observer/filing/0001493152-25-015068.json
- Plain text: https://secwatch.observer/filing/0001493152-25-015068.txt

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