---
schema_version: "secwatch.filing_event.v1"
accession: "0001641172-25-000626"
form_type: "8-K"
ticker: "INBS"
cik: "0001725430"
company_name: "INTELLIGENT BIO SOLUTIONS INC."
filed_at: "2025-03-25T23:59:59+00:00"
generated_at: "2026-05-24T05:53:03.352691+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.55
calibrated_materiality_score: 0.55
confidence: "high"
source: SEC EDGAR
---

# Intelligent Bio Solutions' FDA clearance process on track for 2025 U.S. launch

## Summary
- 510(k) submitted Dec 18, 2024; FDA issued Additional Information request, pausing 90-day review clock.
- Company responding to AI request; clearance expected within 3–6 months or longer if additional data needed.
- System demonstrated 94.1% accuracy in method comparison study; PK data closely aligned to blood at 95% confidence level.
- Targeting opiate test system for codeine; full panel already in 19 countries with over 400 accounts.

## SEC filing metadata
- accession: 0001641172-25-000626
- form_type: 8-K
- ticker: INBS
- cik: 0001725430
- company_name: INTELLIGENT BIO SOLUTIONS INC.
- filed_at: 2025-03-25T23:59:59+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/1725430/000164117225000626/0001641172-25-000626-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1725430/000164117225000626/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001641172-25-000626
- JSON: https://secwatch.observer/filing/0001641172-25-000626.json
- Plain text: https://secwatch.observer/filing/0001641172-25-000626.txt

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