secwatch.observer — SEC 8-K summary
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Issuer:     INTELLIGENT BIO SOLUTIONS INC. (INBS)
CIK:        0001725430
Form:       8-K
Filed at:   2025-03-25T23:59:59+00:00
Accession:  0001641172-25-000626
Event type: regulatory
Sentiment:  neutral
Materiality: 0.55
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1725430/000164117225000626/0001641172-25-000626-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1725430/000164117225000626/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001641172-25-000626

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer