Intelligent Bio Solutions (INBS) wraps major 510(k) clinical study phase
Rhea-AI Filing Summary
Intelligent Bio Solutions Inc. reported completing its multi-site Method Comparison Study for the Intelligent Fingerprinting Drug Screening System, a key component of its FDA 510(k) program for U.S. clearance to detect the opiate codeine. All clinical data collection across the FDA 510(k) clinical study program is now finished. The study, conducted under ICH GCP guidelines at three independent U.S. clinical sites over three weeks with 135 participants and nine operator participants, is intended to demonstrate that typical workplace users can operate the system accurately by measuring sensitivity, specificity, and accuracy. The company is analyzing data and assembling its 510(k) submission package, targeting submission in the second half of 2026 ahead of planned entry into the U.S. market.
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8-K Event Classification
2 items: 7.01, 9.01
2 items
Item 7.01
Regulation FD Disclosure
Disclosure
Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.
Item 9.01
Financial Statements and Exhibits
Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Key Figures
Study participants: 135 participants
Clinical sites: 3 independent U.S. clinical sites
Study duration: 3 weeks
+2 more
5 metrics
Study participants
135 participants
Total enrollment in the Method Comparison Study
Clinical sites
3 independent U.S. clinical sites
Locations conducting the Method Comparison Study over three weeks
Study duration
3 weeks
Length of the Method Comparison Study for the drug screening system
Operator participants
9 operator participants
Typical workplace screening personnel administering the study
Planned 510(k) submission timing
second half of 2026
Targeted timing for FDA 510(k) submission package
Key Terms
FDA 510(k) submission, International Council for Harmonisation Good Clinical Practice, liquid chromatography-tandem mass spectrometry, sensitivity, specificity, and accuracy, +1 more
5 terms
FDA 510(k) submission regulatory
"underpinning the Company’s FDA 510(k) submission for U.S. market clearance"
An FDA 510(k) submission is a regulatory filing to show a new medical device is sufficiently similar to an already-approved device so it can be marketed in the U.S. without undergoing the most extensive premarket review. For investors, 510(k) clearance is a key milestone that reduces regulatory uncertainty and shortens time to sales—think of it as proving a new product is close enough to an established model to be sold without rebuilding trust from scratch.
International Council for Harmonisation Good Clinical Practice regulatory
"Following ICH GCP (International Council for Harmonisation Good Clinical Practice) guidelines"
liquid chromatography-tandem mass spectrometry technical
"verified via liquid chromatography-tandem mass spectrometry (“LC-MS/MS”) analysis"
Liquid chromatography-tandem mass spectrometry is a laboratory method that first separates a mixture of chemicals in liquid form and then identifies and measures each component by its weight, like first sorting beads by color and then weighing each pile. Investors care because it provides highly precise, trusted data used in drug development, safety testing and quality control; those results influence regulatory approvals, product reliability, timelines and financial risk for companies.
sensitivity, specificity, and accuracy medical
"The study evaluated this by measuring sensitivity, specificity, and accuracy"
workplace drug screening medical
"typical users in occupational health, HR, and workplace safety can operate"
AI-generated analysis. How Rhea-AI works. Not financial advice.
FAQ
What did Intelligent Bio Solutions (INBS) announce on August 11, 2026?
Intelligent Bio Solutions completed its multi-site Method Comparison Study for the Intelligent Fingerprinting Drug Screening System, finishing clinical data collection for its FDA 510(k) clinical study program supporting U.S. clearance for codeine detection.
How many participants were in INBS’s Method Comparison Study?
The Method Comparison Study enrolled 135 participants. Conducted over three weeks at three independent U.S. clinical sites, it was structured to reflect U.S. demographic diversity and used nine operator participants simulating typical workplace screening personnel.
What is the purpose of INBS’s Method Comparison Study for INBS stockholders?
The study was designed to show that typical workplace users can operate the Intelligent Fingerprinting Drug Screening System effectively by measuring sensitivity, specificity, and accuracy in pre-employment and workplace screening environments for inclusion in the FDA 510(k) submission.
When does Intelligent Bio Solutions (INBS) plan to submit its FDA 510(k) package?
Intelligent Bio Solutions is targeting submission in the second half of 2026. With clinical data collection complete, the company is focused on data analysis, compilation, and finalization of its FDA 510(k) submission for U.S. market clearance for codeine detection.
What technology is Intelligent Bio Solutions (INBS) developing for drug screening?
The company is developing the Intelligent Fingerprinting Drug Screening System, which uses fingerprint sweat analysis for rapid, non-invasive testing and screens for recent use of drugs including opiates, cocaine, methamphetamine, and cannabis in workplace settings.
How were samples verified in INBS’s Method Comparison Study?
Specimens from the study are being independently verified via LC-MS/MS (liquid chromatography-tandem mass spectrometry) analysis, while overall data analysis is currently underway as part of preparing the company’s FDA 510(k) submission package.