Intelligent Bio Solutions Inc. (NASDAQ:INBS) announced on Wednesday that it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) to secure regulatory clearance for its Intelligent Fingerprinting Drug Screening System.
The filing focuses on detecting codeine and represents a major push to capture a share of the massive U.S. drug screening market.
Extensive Clinical Evidence Drives Application
To support the FDA submission, the company completed a multi-study clinical program throughout 2026.
Partnering with Cliantha Research and CenExel Clinical Research, Inc., the firm compiled over 15,000 lines of data resulting from 18,000 hours of testing.
