Intelligent Bio Solutions Submits FDA 510(k) Package for Intelligent Fingerprinting Drug Screening System, Seeking U.S. Market Clearance
INBS files a data-heavy FDA 510(k) submission for its fingerprint-based codeine test, aiming to unlock wider access to the U.S. drug screening market.
Rhea-AI Summary
Intelligent Bio Solutions (INBS) has submitted an FDA 510(k) application for its Intelligent Fingerprinting Drug Screening System to detect codeine.
The package is based on a multi-study 2026 clinical program run with Cliantha Research and CenExel Clinical Research, generating over 18,000 hours of data, 18 test reports, more than 170 attachments, and over 15,000 data lines. A Method Comparison Study showed accuracy above 98%, sensitivity above 94%, and 100% specificity, with all samples verified by LC‑MS/MS. Additional studies confirmed usability by non-specialist operators, robustness against common workplace substances, and repeatable performance across more than 1,600 tests at three sites and production runs.
Cybersecurity documentation remediated 100% of medium-risk items and all 19 SBOM vulnerabilities, with third-party verification. FDA clearance, if obtained, is expected to support broader U.S. commercialization beyond Forensic Use Only settings in the multi‑billion‑dollar drug screening market.
Positive
- Method Comparison Study showed >98% accuracy, >94% sensitivity and 100% specificity versus LC‑MS/MS
- Clinical program produced 18 detailed test reports from over 18,000 hours of data collection and 15,000+ data lines
- Precision testing delivered reproducible performance across 1,600+ tests, three production runs and three independent sites
- Cut-off study in 40 adults benchmarked System performance against an FDA-cleared predicate device with LC‑MS/MS confirmation
- Cybersecurity review remediated 100% of medium-risk issues and all 19 SBOM vulnerabilities with independent verification
- FDA 510(k) submission targets exposure to a U.S. drug screening market described as multi-billion-dollar annually
Negative
- U.S. market expansion and use beyond Forensic Use Only remain contingent on future FDA 510(k) clearance
Key Figures
- Accuracy
- above 98%
- Method Comparison Study across three independent U.S. clinical sites
- Sensitivity
- above 94%
- Method Comparison Study for codeine detection
- Specificity
- 100%
- Method Comparison Study for codeine detection
- Precision testing
- more than 1,600 tests
- Three production runs and three independent sites
- Cut-off study participants
- 40 adult participants
- Codeine detection cut-off levels compared with an FDA-cleared predicate device
- Medium-risk vulnerabilities remediated
- 100%
- Cybersecurity and software documentation review
- SBOM vulnerabilities resolved
- all 19
- Independent third-party verification reported no remaining issues
Historical Context
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Method comparison study reported accuracy, sensitivity, and specificity results supporting the FDA package
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ISO 13485 recertification supported the company’s ongoing FDA clearance application
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Multi-site method comparison study completed as a key FDA 510(k) submission component
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
510(k) regulatory
lc-ms/ms medical
ich gcp regulatory
sbom technical
AI-generated analysis. How Rhea-AI works. Not financial advice.
Submission package includes Method Comparison Study, which delivered accuracy above
NEW YORK, Sept. 09, 2026 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc. (Nasdaq: INBS) (“INBS” or the “Company”), a medical technology company delivering intelligent, rapid, non-invasive testing solutions, today announced the submission of its 510(k) premarket notification to the U.S. Food and Drug Administration (FDA), seeking regulatory clearance of its Intelligent Fingerprinting Drug Screening System (the “System”) for detection of the opiate codeine. The submission represents the culmination of data from a structured, multi-study clinical program that the Company has executed throughout 2026, targeting entry into the multi-billion-dollar U.S. drug screening market.
The Company’s 510(k) submission package includes a comprehensive body of clinical evidence generated in partnership with Cliantha Research and CenExel Clinical Research, Inc. The clinical studies were conducted in accordance with FDA guidance and International Council for Harmonisation Good Clinical Practice (ICH GCP) standards. Over 18,000 hours of data collection strengthened the submission, resulting in 18 detailed test reports, and supported by more than 170 attachments. In total, more than 15,000 lines of data were generated, analyzed, and compiled into a package that the Company believes represents the most comprehensive body of clinical evidence it has assembled to date.
Key components included:
- Method Comparison Study: demonstrated accuracy above
98% , sensitivity above94% , and specificity of100% , with all specimens independently verified via liquid chromatography-tandem mass spectrometry ("LC-MS/MS") analysis. - Usability Study: confirmed that the System can be effectively administered by operators with no specialist laboratory knowledge or prior experience, reinforcing its suitability for workplace deployment.
- Interference Study: demonstrated that the presence of everyday substances commonly encountered in workplace environments, including hand creams, alcohol-based products, oils, dirt, and water, does not impact the System's accuracy or codeine specificity, with results confirmed via LC-MS/MS analysis.
- Precision Testing: demonstrated repeatable, reproducible performance across more than 1,600 tests spanning three production runs and three independent sites.
- Cut-off Study: evaluated codeine detection cut-off levels in 40 adult participants, with results compared against an FDA-cleared predicate device and confirmed through LC-MS/MS analysis.
- Cybersecurity & Software Documentation: addressed all cybersecurity review items, with
100% of medium-risk vulnerabilities remediated and all 19 software bill of materials (SBOM) vulnerabilities fully resolved, with independent third-party verification confirming no remaining issues.
These findings collectively demonstrate the System’s accuracy, reliability, specificity, and usability, and the Company’s capacity to meet the requirements of the FDA 510(k) regulatory pathway.
“For the past 12 months, planning and executing the studies to build a strong body of data to support our submission has been our team’s primary goal,” said Harry Simeonidis, President and CEO at Intelligent Bio Solutions. “All of this hard work is reflected in our results, and we have great confidence in our 510(k) package.”
INBS’ drug screening technology is commercially deployed in certain countries outside the U.S. across workplace, law enforcement, and government settings, where the System has demonstrated its value in delivering rapid, non-invasive, and reliable drug screening results. The U.S. drug screening market represents a multi-billion-dollar annual opportunity spanning workplace testing, criminal justice, pain management, law enforcement, and substance abuse treatment. FDA clearance is expected to expand the Company’s addressable market beyond Forensic Use Only settings, supporting its broader U.S. commercialization strategy.
About Intelligent Bio Solutions Inc.
Intelligent Bio Solutions Inc. (Nasdaq: INBS) is a medical technology company delivering intelligent, rapid, non-invasive testing solutions. The Company believes that its Intelligent Fingerprinting Drug Screening System will revolutionize portable testing through fingerprint sweat analysis, which has the potential for broader applications in additional fields. Designed as a hygienic and cost-effective system, the test screens for the recent use of drugs commonly found in the workplace, including opiates, cocaine, methamphetamine, and cannabis. With sample collection in seconds and results in under ten minutes, this technology would be a valuable tool for employers in safety-critical industries. The Company’s current customer segments outside the U.S. include construction, manufacturing and engineering, transport and logistics firms, mining, drug treatment organizations, and coroners.
For more information, visit: https://ibs.inc/
Forward-Looking Statements
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, statements regarding Intelligent Bio Solutions Inc.’s ability to successfully develop and commercialize its drug and diagnostic tests, realize commercial benefits from its partnerships and collaborations, secure regulatory clearance or approvals, and timelines to enter the U.S. market, among others. Although Intelligent Bio Solutions Inc. believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, actual results may differ materially from those expressed or implied by such statements. Intelligent Bio Solutions Inc. has attempted to identify forward-looking statements by terminology, including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “projects,” “intends,” “potential,” “may,” “could,” “might,” “will,” “should,” and “approximately,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those described in Intelligent Bio Solutions’ public filings with the U.S. Securities and Exchange Commission. Any forward-looking statements contained in this release speak only as of the date of this release. Intelligent Bio Solutions undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
Company Contact
Intelligent Bio Solutions Inc.
info@ibs.inc
Investor & Media Contact
Valter Pinto, Managing Director
KCSA Strategic Communications
PH: (212) 896-1254
INBS@kcsa.com
FAQ
What types of clinical studies were included in INBS’s 510(k) submission package?
The submission includes a Method Comparison Study, a Usability Study, an Interference Study, Precision Testing, and a Cut-off Study. These were conducted at three independent U.S. clinical sites in line with FDA guidance and ICH GCP standards, and were supported by cybersecurity and software documentation addressing review items and software bill of materials (SBOM) vulnerabilities.
How was the Intelligent Fingerprinting Drug Screening System evaluated for usability?
The Usability Study showed that the System can be effectively administered by operators with no specialist laboratory knowledge or prior experience, which the company states supports its suitability for deployment in workplace environments.
How did common workplace substances affect the System’s performance in testing?
The Interference Study indicated that everyday substances such as hand creams, alcohol-based products, oils, dirt, and water did not impact the System’s accuracy or codeine specificity. Results were independently confirmed through LC‑MS/MS analysis.
What cybersecurity measures were addressed in the 510(k) package?
Cybersecurity and software documentation addressed all identified review items, with 100% of medium-risk vulnerabilities remediated and all 19 SBOM vulnerabilities resolved. An independent third party verified that no issues remained, according to the company.
Where is the Intelligent Fingerprinting Drug Screening System already in commercial use?
Outside the U.S., the System is commercially deployed in workplace, law enforcement, and government settings, serving customers in sectors such as construction, manufacturing and engineering, transport and logistics, mining, drug treatment organizations, and coroners.
Which drugs does the Intelligent Fingerprinting Drug Screening System screen for outside this codeine-focused submission?
The company states that the System is designed as a hygienic and cost-effective test that screens for recent use of drugs commonly found in the workplace, including opiates, cocaine, methamphetamine, and cannabis, with sample collection in seconds and results in under ten minutes.