secwatch.observer — SEC 8-K summary
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Issuer:     INTELLIGENT BIO SOLUTIONS INC. (INBS)
CIK:        0001725430
Form:       8-K
Filed at:   2026-09-01T21:10:28+00:00
Accession:  0001493152-26-041055
Event type: regulatory
Sentiment:  positive
Materiality: 0.65
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

INBS reports 98.2% accuracy in codeine drug screen study; 510(k) submission on track for Sept 2026
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- Multi-site study across 3 U.S. clinical sites: 98.2% accuracy, 94.6% sensitivity, 100% specificity for opiate codeine.
- Improvement from prior Nov 2024 study: ~94% accuracy and 82% sensitivity; specificity unchanged at 100%.
- Results measured against validated LC-MS/MS reference method; 70 true positives, 144 true negatives, 0 false positives.
- Company accelerated filing timeline; expects to submit 510(k) application in September 2026 for U.S. market entry.
- CEO Harry Simeonidis: 'we now have everything we need for our 510(k) submission.'

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1725430/000149315226041055/0001493152-26-041055-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1725430/000149315226041055/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-26-041055

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