Intelligent Bio Solutions Submits FDA 510(k) Package for Intelligent Fingerprinting Drug Screening System, Seeking U.S. Market Clearance
Intelligent Bio Solutions (Nasdaq: INBS) submitted its FDA 510(k) premarket notification seeking clearance of its Intelligent Fingerprinting Drug Screening System for detecting the opiate codeine — the key regulatory step toward U.S. market entry. The package compiles a year-long clinical program run with Cliantha Research and CenExel Clinical Research: accuracy above 98%, sensitivity above 94%, and 100% specificity confirmed by LC-MS/MS, plus more than 1,600 precision tests across three production runs and three independent sites. FDA clearance would move the fingerprint-based system beyond Forensic Use Only status and open a U.S.
Key figures
- Drug Name
- Intelligent Fingerprinting Drug Screening System (codeine detection)
- Accuracy
- above 98%
- Data lines
- more than 15,000
- Attachments
- more than 170
- Sensitivity
- above 94%
- Specificity
- 100%
- Test reports
- 18
- Precision sites
- 3
- Precision tests
- more than 1,600
- Data collection hours
- over 18,000
- Cutoff study participants
- 40
- Sbom vulnerabilities resolved
- 19
AI analysis
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