Intelligent Bio seeks FDA clearance for codeine test
INBS has filed a 510(k) with the FDA for its codeine fingerprint drug screening system, backed by extensive 2026 clinical data and strong accuracy metrics.
Rhea-AI Filing Summary
INTELLIGENT BIO SOLUTIONS INC. (INBS) reports that on September 9, 2026 it submitted a 510(k) premarket notification to the U.S. FDA, seeking regulatory clearance for its Intelligent Fingerprinting Drug Screening System to detect the opiate codeine. The submission is based on a structured 2026 clinical program run with Cliantha Research and CenExel Clinical Research under FDA guidance and ICH GCP standards, including more than 18,000 hours of data collection, 18 detailed test reports, over 170 attachments and more than 15,000 lines of analyzed data.
A key Method Comparison Study showed accuracy above 98%, sensitivity above 94% and 100% specificity, with specimens verified by LC‑MS/MS. Additional usability, interference, precision, and cut-off studies, plus cybersecurity and software documentation resolving all 19 SBOM vulnerabilities and 100% of medium-risk issues, were included. The company frames this as supporting entry into the multi‑billion‑dollar U.S. drug screening market if FDA clearance is obtained, expanding its current non‑U.S. deployments.
Positive
- Submitted FDA 510(k) for its Intelligent Fingerprinting Drug Screening System for codeine, supported by a large 2026 clinical program and a Method Comparison Study showing accuracy above 98%, sensitivity above 94% and 100% specificity, positioning INBS to pursue the multi‑billion‑dollar U.S. drug screening market upon potential clearance.
Negative
- None.
Insights
Analyzing...
8-K Event Classification
3 items: 7.01, 8.01, 9.01
3 items
Item 7.01
Regulation FD Disclosure
Disclosure
Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.
Item 8.01
Other Events
Other
Voluntary disclosure of events the company deems important to shareholders but not covered by other items.
Item 9.01
Financial Statements and Exhibits
Exhibits
Financial statements, pro forma financial information, or exhibit attachments filed with this report.
Key Figures
Method Comparison Study accuracy: Above 98%
Method Comparison Study sensitivity: Above 94%
Method Comparison Study specificity: 100%
+5 more
8 metrics
Method Comparison Study accuracy
Above 98%
Accuracy for codeine detection in the Intelligent Fingerprinting Drug Screening System
Method Comparison Study sensitivity
Above 94%
Sensitivity for codeine detection in the Intelligent Fingerprinting Drug Screening System
Method Comparison Study specificity
100%
Specificity for codeine detection with LC‑MS/MS verification
Data collection hours
Over 18,000 hours
Total data collection time contributing to the 510(k) package
Test reports in submission
18 reports
Number of detailed test reports in the 510(k) submission
Supporting attachments
More than 170 attachments
Additional documents included in the 510(k) package
Precision testing volume
More than 1,600 tests
Precision testing across three production runs and three independent sites
SBOM vulnerabilities resolved
19 vulnerabilities
All software bill of materials vulnerabilities fully resolved with third‑party verification
Key Terms
510(k) premarket notification, Intelligent Fingerprinting Drug Screening System, International Council for Harmonisation Good Clinical Practice (ICH GCP), liquid chromatography-tandem mass spectrometry (LC-MS/MS), +2 more
6 terms
510(k) premarket notification regulatory
"announced the submission of its 510(k) premarket notification to the U.S. Food and Drug Administration"
A 510(k) premarket notification is a regulatory submission to the U.S. Food and Drug Administration that shows a new medical device is as safe and effective as an existing, legally marketed device. Think of it like demonstrating your new model performs like a trusted older model so it can be sold; for investors, 510(k) clearance is a key hurdle that affects how quickly a device can reach market, development cost, and the level of regulatory risk in a medical-device investment.
Intelligent Fingerprinting Drug Screening System medical
"regulatory clearance of its Intelligent Fingerprinting Drug Screening System for detection of the opiate codeine"
International Council for Harmonisation Good Clinical Practice (ICH GCP) medical
"conducted in accordance with FDA guidance and International Council for Harmonisation Good Clinical Practice (ICH GCP) standards"
liquid chromatography-tandem mass spectrometry (LC-MS/MS) technical
"all specimens independently verified via liquid chromatography-tandem mass spectrometry ("LC-MS/MS") analysis"
Liquid chromatography-tandem mass spectrometry (LC-MS/MS) is an advanced laboratory technique used to identify and measure small molecules and chemicals in complex samples with high precision. Think of it as a highly sensitive sorting and detection system that separates substances and then precisely analyzes their composition. This method is important to investors because it helps ensure the safety, quality, and authenticity of products like medicines and food, which can impact company performance and market trust.
predicate device regulatory
"results compared against an FDA-cleared predicate device and confirmed through LC-MS/MS analysis"
A predicate device is an already‑marketed medical product that regulators accept as a reference point when assessing a new, similar device. Think of it as a proven model a maker cites to show the new product works and is safe in the same way — using that comparison can speed regulatory clearance, lower development cost and reduce uncertainty. For investors, reliance on a predicate device often means faster market access and lower regulatory risk, while novel designs without a close predicate may face longer reviews and higher costs.
software bill of materials (SBOM) technical
"all 19 software bill of materials (SBOM) vulnerabilities fully resolved"
A software bill of materials (SBOM) is a detailed inventory that lists all the pieces, libraries and third‑party code used to build a software product — like an ingredient label for an app. Investors pay attention because SBOMs expose security weaknesses, licensing obligations and maintenance needs that can create unexpected costs, outages or legal risk; having a clear SBOM helps assess operational resilience and the potential future cost of keeping the software safe and compliant.
FAQ
What did INBS (Intelligent Bio Solutions Inc.) announce in this 8-K filing?
INBS announced it submitted a 510(k) premarket notification to the U.S. FDA seeking regulatory clearance for its Intelligent Fingerprinting Drug Screening System to detect the opiate codeine, backed by a multi‑study 2026 clinical program and detailed supporting documentation.
What performance did INBS report for its codeine drug screening system (INBS)?
A Method Comparison Study for INBS’s system reported accuracy above 98%, sensitivity above 94% and 100% specificity, with all specimens independently verified using LC‑MS/MS, supporting the company’s FDA 510(k) submission for codeine detection.
How extensive was the clinical data package for INBS’s 510(k) submission?
INBS reports its 510(k) package includes data from over 18,000 hours of collection, 18 detailed test reports, more than 170 attachments and over 15,000 lines of analyzed data, generated across multiple studies with Cliantha Research and CenExel Clinical Research.
What additional studies did INBS include beyond the Method Comparison Study?
INBS’s package includes usability, interference, precision and cut-off studies, plus cybersecurity and software documentation. Precision testing covered more than 1,600 tests, and cut-off evaluation involved 40 adult participants compared with an FDA‑cleared predicate device.
How did INBS address cybersecurity in its 510(k) package?
The company states its cybersecurity and software documentation addressed all review items, with 100% of medium-risk vulnerabilities remediated and all 19 SBOM vulnerabilities fully resolved, supported by independent third‑party verification confirming no remaining issues.
What market opportunity does INBS see if its 510(k) is cleared?
INBS describes the U.S. drug screening market as a multi‑billion‑dollar annual opportunity across workplace testing, criminal justice, pain management, law enforcement and substance abuse treatment, and states that FDA clearance is expected to expand its addressable market beyond Forensic Use Only settings.
AI-generated analysis. How Rhea-AI works. Not financial advice.
