Intelligent Bio Solutions Completes Precision Testing for FDA 510(k) Submission of Fingerprint-Based Codeine Drug Screening System
核心洞察
Intelligent Bio Solutions completed precision testing involving over 1,600 tests across three production runs and three independent sites for its fingerprint-based drug screening system.
The precision testing confirmed consistent, repeatable, and reproducible performance for codeine detection, supporting the company's upcoming FDA 510(k) submission.
Results will be combined with data from the Cut-off Study, Method Comparison Study, and Interference Study to address safety, accuracy, usability, specificity, security, and precision.
Intelligent Bio Solutions Inc. (Nasdaq: INBS) announced on July 21, 2026, the completion of precision testing for its Intelligent Fingerprinting Drug Screening System, a critical milestone on the path toward FDA 510(k) submission for U.S. market clearance. The system is designed to detect the opiate (搜索) codeine through non-invasive fingerprint sweat analysis, offering a rapid alternative to traditional urine, oral fluid, and blood-based drug screening methods.
The precision testing, conducted following the company's clinical cut-off adjustment, encompassed more than 1,600 tests across three production runs and three independent sites. Results demonstrated repeatable and reproducible performance across all runs and sites, confirming the system's consistency under varied manufacturing conditions and operating environments.
"Completing over 1,600 tests across multiple independent sites and production runs puts us firmly on track for our FDA 510(k) submission, and, once FDA 510(k) clearance is obtained, a planned U.S. launch," said Harry Simeonidis, President and CEO of Intelligent Bio Solutions. "Every clinical study and test we complete adds to the evidence supporting our submission and brings us closer to the U.S. market. The depth of our precision testing dataset reflects the rigor we are applying to get there."
Building a Comprehensive Regulatory Package
The precision testing results will form part of a broader FDA 510(k) submission package that also includes penetration testing data and findings from three previously announced studies: the Cut-off Study, the Method Comparison Study, and the Interference Study. Together, these data are intended to address the safety, accuracy, usability, specificity, security, and precision of the Intelligent Fingerprinting Drug Screening System.
The company's technology platform uses fingerprint sweat analysis to screen for recent use of drugs commonly encountered in workplace settings, including opiates, cocaine, methamphetamine, and cannabis. Sample collection takes seconds, and results are available in under ten minutes — features that distinguish the system from conventional testing modalities that require specialized collection facilities and longer turnaround times.
Market Opportunity and Applications
The U.S. drug screening market represents a multi-billion-dollar annual opportunity, according to the company, with applications spanning workplace testing, criminal justice, pain management, and substance abuse treatment. Intelligent Bio Solutions positions its non-invasive fingerprint technology as offering distinct advantages, including rapid results, flexible screening at any time and location, and a detection window designed to support screening for recent drug use.
Outside the United States, the company already serves customer segments including construction, manufacturing and engineering, transport and logistics firms, mining, drug treatment organizations, and coroners. The planned FDA 510(k) clearance would open access to the U.S. market, where employers in safety-critical industries represent a key target demographic.
The company has not yet specified a timeline for the FDA 510(k) submission or anticipated clearance decision, noting that forward-looking statements involve risks and uncertainties including the ability to secure regulatory clearance and successfully commercialize the technology.