---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-25-011634"
form_type: "8-K"
ticker: "INBS"
cik: "0001725430"
company_name: "INTELLIGENT BIO SOLUTIONS INC."
filed_at: "2025-08-06T23:59:59+00:00"
generated_at: "2026-05-17T19:39:17.797252+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.55
calibrated_materiality_score: 0.55
confidence: "high"
source: SEC EDGAR
---

# INBS submits FDA 510(k) AI response; expects clearance decision within six weeks

## Summary
- Submitted over 1,900 pages including 23 detailed test reports and 7,800 data lines from 10,000 hours of testing.
- New cybersecurity and performance data reinforce fingerprint sweat drug screening platform for U.S. market entry in 2025.
- Company serves 450+ accounts in 24 countries with 18 global distribution partners.
- FDA response anticipated within six weeks.
- CEO calls U.S. market entry a top priority given multi-billion-dollar commercial opportunity.

## SEC filing metadata
- accession: 0001493152-25-011634
- form_type: 8-K
- ticker: INBS
- cik: 0001725430
- company_name: INTELLIGENT BIO SOLUTIONS INC.
- filed_at: 2025-08-06T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.55
- calibrated_materiality_score: 0.55
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1725430/000149315225011634/0001493152-25-011634-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1725430/000149315225011634/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-25-011634
- JSON: https://secwatch.observer/filing/0001493152-25-011634.json
- Plain text: https://secwatch.observer/filing/0001493152-25-011634.txt

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