Intelligent Bio Solutions Inc. (Nasdaq: INBS) announced on September 9, 2026, that it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA). The submission seeks regulatory clearance for the company's Intelligent Fingerprinting Drug Screening System specifically for the detection of the opiate codeine.
The filing includes a comprehensive clinical package generated throughout 2026, executed in partnership with Cliantha Research and CenExel Clinical Research, Inc. The data collection effort spanned over 18,000 hours and resulted in 18 detailed test reports supported by more than 170 attachments and over 15,000 lines of data.
Key components of the submission include a Method Comparison Study demonstrating accuracy above 98%, sensitivity above 94%, and specificity of 100%. The Usability Study confirmed that the system can be effectively administered by operators without specialist laboratory knowledge. Additionally, an Interference Study verified that everyday substances such as hand creams, alcohol-based products, and dirt do not impact the system's accuracy.
The package also includes Precision Testing across more than 1,600 tests and a Cut-off Study involving 40 adult participants. Furthermore, the company addressed cybersecurity requirements, reporting that 100% of medium-risk vulnerabilities have been remediated and all 19 software bill of materials vulnerabilities have been resolved with third-party verification.
The company stated that its technology is currently commercially deployed outside the U.S. in sectors such as construction, manufacturing, and law enforcement. The filing notes that FDA clearance would allow the company to expand its addressable market beyond Forensic Use Only settings.
