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.
The team organized these findings into 18 detailed test reports backed by more than 170 attachments. Management considers this submission the most robust collection of clinical evidence the company has assembled to date.
Proven Accuracy And Usability
Method comparison trials highlighted the system’s strong performance, revealing over 98% accuracy, higher than 94% sensitivity, and 100% specificity.
Liquid chromatography-tandem mass spectrometry independently verified all specimens.
Usability studies showed that operators need no specialized laboratory background to run the system efficiently.
Interference tests further validated the technology, proving that everyday workplace substances, including hand lotions, dirt, and water, do not degrade accuracy.
Furthermore, precision testing demonstrated reproducible results across 1,600 tests conducted at three separate sites.
Developers also remediated all software vulnerabilities and cleared independent third-party cybersecurity reviews.
Targeting US Market
International operators already use the non-invasive drug screening technology in law enforcement, government, and workplace settings.
Securing FDA clearance would enable Intelligent Bio Solutions to expand beyond Forensic Use Only applications and commercialize the system across the broader U.S. pain management and substance abuse treatment.
INBS Price Action: Intelligent Bio Solutions shares were down 3.26% at $2.08 during premarket trading on Wednesday. The stock is trading near its 52-week low of $1.52, according to Benzinga Pro data.
Image via Shutterstock/ Jeppe Gustafsson
