INBS Submits FDA 510(k) for Codeine Detection System with 98%+ Accuracy Data
INBS sits 47% above its 52-week low of $1.52.
Summary
INBS submitted its FDA 510(k) package for codeine detection, backed by clinical data showing >98% accuracy and 100% specificity. Clearance would unlock the U.S. drug screening market.
Key Events · Product Development and Regulatory · INBS
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FDA 510(k) Submission Filed
Company submitted its 510(k) premarket notification to the FDA on September 9, 2026, seeking clearance for its Intelligent Fingerprinting Drug Screening System for codeine detection.
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Clinical Data Exceeds Benchmarks
Method Comparison Study showed accuracy above 98%, sensitivity above 94%, and 100% specificity across three independent U.S. clinical sites, with all specimens verified via LC-MS/MS.
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Comprehensive Submission Package
Package includes over 18,000 hours of data collection, 18 detailed test reports, more than 170 attachments, and over 15,000 lines of data generated across six study types.
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Cybersecurity Fully Remediated
100% of medium-risk vulnerabilities remediated and all 19 SBOM vulnerabilities resolved, with independent third-party verification confirming no remaining issues.
Analysis · INBS · Industrial Applications And Services
Intelligent Bio Solutions has formally submitted its 510(k) premarket notification to the FDA for its Intelligent Fingerprinting Drug Screening System targeting codeine detection. The submission package includes strong clinical data — accuracy above 98%, sensitivity above 94%, and 100% specificity across three independent U.S. clinical sites — plus over 18,000 hours of data collection and 15,000 lines of data. This is the culmination of a year-long clinical program and represents the company's most comprehensive regulatory filing to date. FDA clearance would open the multi-billion-dollar U.S. drug screening market beyond Forensic Use Only settings, a major commercial expansion for a company with a going concern warning and only $4.2M in fiscal 2026 revenue.
How filings like this one have moved
In the 30 days to Sep 10, 2026, 35.6% of the 1819 measured filings Wiseek scored 8 moved their stock by 5% or more by the next session's close. The median move was 0.00%. These are measured outcomes after filings of this importance, not a forecast for this one.
Measured one observation per ticker per day, after exclusions. Current figures: Filing Impact Tracker · open dataset
At the time of this filing, INBS was trading at $2.24 on NASDAQ in the Industrial Applications And Services sector, with a market capitalization of approximately $6.5M. The 52-week trading range was $1.52 to $24.90. This filing was assessed with positive market sentiment and an importance score of 8 out of 10.