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AI brief of an SEC Form 8-K · INTELLIGENT BIO SOLUTIONS INC. (INBS)

Intelligent Bio Solutions submits FDA 510(k) for codeine drug screening system

Neutral Impact 3 of 5 legal/regulatory Written later

Intelligent Bio Solutions said it submitted a 510(k) premarket notification to the FDA seeking clearance of its Intelligent Fingerprinting Drug Screening System for detecting codeine. The company says the submission is based on a 2026 clinical program and that FDA clearance is expected to expand its addressable U.S. market beyond forensic-use-only settings. The filing does not state a clearance timeline or any financial figures.

Key points

  • Submission announced September 9, 2026 for codeine detection on the Intelligent Fingerprinting Drug Screening System
  • Method Comparison Study reported accuracy above 98%, sensitivity above 94% and 100% specificity across three U.S. clinical sites
  • Cybersecurity review reported 100% of medium-risk vulnerabilities remediated and all 19 SBOM vulnerabilities resolved
  • Filing gives no FDA review timeline and no financial results or guidance

The filing

CompanyINTELLIGENT BIO SOLUTIONS INC. (INBS)
Form8-K, current report
Filed with the SECSep 9, 2026, 8:50 AM ET
Accession number0001493152-26-041901

Items reported: 7.01 Regulation FD Disclosure8.01 Other Events

Read the filing on SEC.gov ↗

Written by AI on Nov 9, 2026, 8:53 AM ET, from this filing only. Written later: this filing was briefed after the fact, when past filings were added to the site, so the brief may be read with hindsight; the filing itself is the record of what was known on September 09, 2026.

Briefs are written by AI from the filing text and can contain mistakes — open the filing before acting on anything. Impact (1-5) and tone are the AI's reading of the filing for shareholders, not a price forecast. Not investment advice.