Intelligent Bio Solutions starts multi-site FDA 510(k) study for opiate codeine fingerprint test

INTELLIGENT BIO SOLUTIONS INC.

Study will enroll 135 donor participants across multiple sites; partnered with CenExel Clinical Research.
Designed to validate accuracy, sensitivity, specificity of the Intelligent Fingerprinting Drug Screening System for workplace use.
Company expects to complete enrollment and data collection by end of July 2026.
User performance evaluation by non-laboratory personnel is a key part of the 510(k) submission.
Results will be confirmed via LC-MS/MS; study follows ICH GCP guidelines.

Machine-readable event card

schema_version: secwatch.filing_event.v1
accession: 0001493152-26-026780
form_type: 8-K
ticker: INBS
cik: 0001725430
company_name: INTELLIGENT BIO SOLUTIONS INC.
filed_at: 2026-06-02T12:48:18+00:00
discovered_at: 2026-06-02T12:50:00.265194+00:00
generated_at: 2026-06-02T12:50:11.103008+00:00
sec_items: ["7.01", "9.01"]
event_type: regulatory
sentiment: neutral
materiality_score: 0.5
calibrated_materiality_score: 0.5
confidence: high
secwatch_canonical_url: https://secwatch.observer/filing/0001493152-26-026780
json_url: https://secwatch.observer/filing/0001493152-26-026780.json
markdown_url: https://secwatch.observer/filing/0001493152-26-026780.md
text_url: https://secwatch.observer/filing/0001493152-26-026780.txt
edgar_index_url: https://www.sec.gov/Archives/edgar/data/1725430/000149315226026780/0001493152-26-026780-index.htm
edgar_primary_document_url: https://www.sec.gov/Archives/edgar/data/1725430/000149315226026780/form8-k.htm
generated_by_model: deepseek-v4-flash:cloud@v2
review_status: machine_generated
human_reviewed: false
corrected: false
correction_note: null
correction_timestamp: null
superseded_by: null

BDX

BD resumes ChloraPrep shipments after voluntary hold; all final release testing acceptable

BECTON DICKINSON & CO May 29, 2026, 8:39 AM ET regulatory Items 7.01, 9.01

same SEC item: 7.01, 9.01 same event type: regulatory similar materiality

TMC

NOAA certifies TMC USA's exploration license for USA B; 1.02B tonne nodule resource

TMC the metals Co Inc. May 28, 2026, 9:04 AM ET regulatory Items 7.01, 9.01

same SEC item: 7.01, 9.01 same event type: regulatory similar materiality

D-Wave awarded year 2 funding for superconducting qubit fabrication project under U.S. DOW program

D-Wave Quantum Inc. May 26, 2026, 7:01 AM ET regulatory Items 7.01, 9.01

same SEC item: 7.01, 9.01 same event type: regulatory similar materiality

RCI Hospitality regains Nasdaq compliance after filing delayed Q1 10-Q

RCI HOSPITALITY HOLDINGS, INC. June 1, 2026, 3:08 PM ET regulatory Items 8.01, 9.01