secwatch.observer — SEC 8-K summary
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Issuer:     INTELLIGENT BIO SOLUTIONS INC. (INBS)
CIK:        0001725430
Form:       8-K
Filed at:   2026-09-09T12:50:25+00:00
Accession:  0001493152-26-041901
Event type: regulatory
Sentiment:  positive
Materiality: 0.65
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Intelligent Bio Solutions files FDA 510(k) for fingerprint drug screening codeine detection
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- Submitted 510(k) to FDA on Sept 9, 2026 seeking clearance for opiate codeine detection via fingerprint sweat analysis.
- Method Comparison Study: accuracy >98%, sensitivity >94%, specificity 100%, verified by LC-MS/MS across 3 U.S. clinical sites.
- Package includes 18 test reports, 170+ attachments, 15,000+ data lines from 18,000+ hours of data collection.
- Precision testing: 1,600+ tests across 3 production runs and 3 sites; cut-off study in 40 adults vs FDA-cleared predicate.
- Cybersecurity: 100% of medium-risk vulnerabilities remediated; all 19 SBOM vulnerabilities resolved with third-party verification.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1725430/000149315226041901/0001493152-26-041901-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1725430/000149315226041901/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-26-041901

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