FDA requests new 510(k) for Intelligent Bio (NASDAQ: INBS) drug screening system

Rhea-AI Filing Summary

Intelligent Bio Solutions Inc. reported that the FDA has requested additional information on its Intelligent Fingerprinting Drug Screening System, requiring the company to submit a new 510(k) notification. The FDA’s requests were communicated in a letter dated September 12, 2025. The company plans to provide an investor update within the next ten days to outline a revised timeline for potential FDA 510(k) clearance of the drug screening system.

Positive

• None.

Negative

• FDA setback and delay risk: The FDA requested additional information on the Intelligent Fingerprinting Drug Screening System and is requiring a new 510(k) submission, which may delay potential clearance and commercialization.

Insights

Regulatory and biotech analyst

FDA is requiring a new 510(k) submission, introducing delay and added uncertainty.

Intelligent Bio Solutions Inc. disclosed that the FDA requested additional information on its Intelligent Fingerprinting Drug Screening System, leading to the need for a new 510(k) notification. This indicates the original submission did not satisfy all FDA requirements, which can extend the review process.

This development matters because regulatory clearance is typically a key step before broad commercialization of a medical device. A required resubmission can mean more time and resources devoted to regulatory work, while revenue opportunities from the product may be pushed back until clearance is achieved.

The company stated it expects to hold an investor update within the next ten days to outline an updated timeline for FDA clearance. That future update will clarify how long the revised regulatory path may take and how it could affect the rollout of the Intelligent Fingerprinting Drug Screening System.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

the Securities Exchange Act of 1934

Date of Report (Date of Earliest Event Reported): September 17, 2025

INTELLIGENT BIO SOLUTIONS INC.

(Exact name of registrant as specified in its charter)

Delaware		001-39825		82-1512711
(State of Incorporation)		(Commission File Number)		(IRS employer identification no.)

135 West, 41st Street, 5th Floor

New York, NY 10036

(Address of principal executive offices, including zip code)

Registrant’s telephone number, including area code: (646) 828-8258

N/A

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, $0.01 par value		INBS		The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2). Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 8.01 Other Events.

On September 17, 2025, Intelligent Bio Solutions Inc. (the “Company”), issued a press release (the “Press Release”) providing an update on the FDA 510(k) clearance process for its Intelligent Fingerprinting Drug Screening System. The Press Release announced that the FDA has requested new additional information about the Intelligent Fingerprinting Drug Screening System that requires the Company to resubmit a new 510(k) notification. The FDA’s requests were made in a letter dated September 12, 2025. The Company expects to have an investor update in the next ten days outlining an updated timeline for FDA clearance.

A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K. The foregoing disclosure is qualified in its entirety by the full text of the Press Release.

Item 9.01 Financial Statements and Exhibits.

No.		Description
99.1		Press Release, dated September 17, 2025
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: September 17, 2025
	INTELLIGENT BIO SOLUTIONS INC.
	By:	/s/ Spiro Sakiris
	Name:	Spiro Sakiris
	Title:	Chief Financial Officer

FAQ

What did Intelligent Bio Solutions Inc. (INBS) disclose in this 8-K?

The company reported that the FDA requested additional information on its Intelligent Fingerprinting Drug Screening System, requiring a new 510(k) notification, and it plans an investor update with a revised clearance timeline.

What is happening with INBS’s Intelligent Fingerprinting Drug Screening System FDA 510(k) process?

The FDA sent a letter dated September 12, 2025 requesting new additional information, and as a result Intelligent Bio Solutions Inc. must resubmit a new 510(k) notification for the device.

Does this update mean the Intelligent Bio Solutions drug screening system is FDA cleared?

No. Intelligent Bio Solutions Inc. reported that the FDA has requested additional information and a new 510(k) submission, and the company intends to provide an updated timeline for potential clearance in an upcoming investor update.

When will Intelligent Bio Solutions Inc. provide more details on the FDA timeline?

The company stated that it expects to have an investor update within the next ten days to outline an updated timeline for FDA 510(k) clearance of the Intelligent Fingerprinting Drug Screening System.

What exhibit is attached to the Intelligent Bio Solutions Inc. 8-K?

The 8-K includes as Exhibit 99.1 a press release dated September 17, 2025 that provides additional detail on the FDA 510(k) clearance process for the Intelligent Fingerprinting Drug Screening System.

What type of event is reported for Intelligent Bio Solutions Inc. in this document?

The document reports an Item 8.01 Other Events disclosure describing the FDA’s request for additional information and the need to file a new 510(k) for the Intelligent Fingerprinting Drug Screening System.