About Subcheck
Subcheck is a diagnostic technology company specializing in rapid, point-of-care fentanyl detection. We design, manufacture, and distribute proprietary test kits for public health agencies, pharmacies, and harm reduction programs across the United States.
Make fentanyl detection accessible, reliable, and scalable
The fentanyl crisis demands detection tools that work in the field — not just in the lab. Subcheck exists to close the gap between laboratory-grade immunoassay technology and the realities of community-level distribution.
We combine proprietary detection chemistry with distribution-ready product design, delivering complete test kits that require no separate sourcing, no assembly, and no specialized training to use.
From research to nationwide distribution
Research begins on broad-spectrum fentanyl detection. Initial antibody screening identifies multi-epitope approach as viable path beyond single-antibody limitations.
US Patent 11,874,279 filed for multi-epitope detection methodology — a cocktail-based immunoassay architecture targeting multiple binding sites across the fentanyl molecular family.
First distribution-ready complete test strip kit ships at $0.20 per unit. SC-1 bundles strip, micro-scoop, buffer, and multilingual instructions.
Pacific Northwest deployment across 127 syringe service programs in 36 counties. First large-scale field validation of broad-spectrum detection.
One million tests distributed. Post-market surveillance confirms >98% concordance with laboratory-confirmed samples across 80+ analog variants.
Mechanical analyzer enters distribution — automates dissolution, timing, and readout. Eliminates the three primary sources of human error in manual testing.
Quality management system certified to ISO 13485:2016. Full compliance with 21 CFR Part 820 and GMP standards.
2.4 million tests shipped to programs across all 50 states. Active procurement relationships with 38 state health departments.
End-to-end diagnostic capability
Research & Development
In-house immunoassay development, antibody cocktail formulation, and ongoing analog panel expansion. Our detection panel is updated quarterly as new synthetic opioids emerge in the supply.
Product Design & Engineering
Proprietary industrial design for both SC-1 (manual kit) and SC-X (mechanical analyzer). Every component — from the micro-scoop to the dissolution mechanism — is engineered for field conditions.
Manufacturing & QC
ISO 13485-certified production with rigorous quality control. Every batch tested for sensitivity, specificity, and stability before release. Full lot-level traceability from raw material to distribution.
Distribution & Logistics
Direct-to-entity shipping to 1,200+ distribution points across the United States. Flexible models — centralized, decentralized, or hybrid — adapted to each jurisdiction's infrastructure.
Compliance & Reporting
Grant-compliant reporting pre-formatted for CDC OD2A, SAMHSA SOR, and Medicaid. Proactive expiration management with automated alerts and FIFO rotation guidance.
Training & Support
Structured curriculum with train-the-trainer delivery in 8 languages. Dedicated account managers with quarterly program reviews and CEU-eligible certification.