secwatch.observer — SEC 8-K summary
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Issuer:     INTELLIGENT BIO SOLUTIONS INC. (INBS)
CIK:        0001725430
Form:       8-K
Filed at:   2026-06-02T12:48:18+00:00
Accession:  0001493152-26-026780
Event type: regulatory
Sentiment:  neutral
Materiality: 0.50
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Intelligent Bio Solutions starts multi-site FDA 510(k) study for opiate codeine fingerprint test
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- Study will enroll 135 donor participants across multiple sites; partnered with CenExel Clinical Research.
- Designed to validate accuracy, sensitivity, specificity of the Intelligent Fingerprinting Drug Screening System for workplace use.
- Company expects to complete enrollment and data collection by end of July 2026.
- User performance evaluation by non-laboratory personnel is a key part of the 510(k) submission.
- Results will be confirmed via LC-MS/MS; study follows ICH GCP guidelines.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1725430/000149315226026780/0001493152-26-026780-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1725430/000149315226026780/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-26-026780

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