Open Source & Distribution
Philosophy
This project is explicitly not a medical device. It is a food analysis toolkit — measuring compounds in food, not in people. The framing matters both legally and scientifically.
Core goals:
- Replace diet lore with actual measurements
- Make food compound testing accessible to people who can’t afford lab testing
- Build a community dataset that improves on the inconsistent published food tables
- Democratize the science that currently only exists in academic papers
Open Source Strategy
Everything is published openly under a permissive license (CC-BY or similar):
- Protocols (this vault, exported as PDF/web)
- Arduino firmware (GitHub)
- STL files for colorimeter enclosure and cuvette holder (Printables/Thingiverse)
- Standard curve spreadsheet templates (Google Sheets)
- Data logging template (this vault + Google Form)
- Community data sheet (public Google Sheet or Airtable)
Why open source over selling:
- No FDA IVD regulatory exposure
- Maximum reach — anyone can build from the docs
- Community can improve the protocols
- Fits mutual aid / democratize knowledge values
- A convenience kit can still be offered separately for cost recovery
Convenience Kit (Optional)
For people who don’t want to source chemicals themselves, offer a pre-measured kit as a community service (not for profit):
Kit contents:
- Pre-weighed reagent packets (Trinder reagent components, RB4-Cu working reagent)
- Calibration standard vials (sodium salicylate, sodium oxalate)
- Plastic cuvettes (10)
- Plastic sample tubes (10)
- Coffee filters (10)
- Protocol card (laminated)
- QR code linking to full documentation
What the kit does NOT include:
- HCl and NaOH — purchasable locally (hardware store), reduces shipping hazmat issues
- Colorimeter hardware — open source build docs provided
- Histamine enzyme strips — purchasable separately from BioAssay Systems
Labeling:
- “Food compound analysis reagents”
- “For measuring salicylates and oxalates in food samples”
- “Not for medical diagnostic use”
- Safety information for each reagent
- Full protocol reference
Regulatory Positioning
The kit tests food, not the person. This is the same category as:
- Wine sulfite test kits
- Water quality test kits
- Food freshness indicators
- pH test strips for home brewing
None of these require FDA clearance. The key is consistent framing — never make health claims, always frame as food quality/composition testing.
Do:
- “Measure oxalate content in your spinach”
- “Compare histamine levels in fresh vs. stored meat”
- “Test salicylate content in garden produce”
Don’t:
- “Diagnose histamine intolerance”
- “Test if food is safe for MCAS”
- “Determine if you will react to this food”
Community Data
A public shared dataset is the long-term value of this project. Even 50 users measuring consistently generates more reliable data than most of the published tables the diet lists are based on.
Minimum viable dataset fields:
- Food type
- Source (homegrown/store)
- Days since harvest/purchase
- Storage method
- Salicylate reading (mM)
- Oxalate reading (µmol/L)
- Total amine screen (ratio)
- Histamine strip result (ppm, if run)
- Protocol version used
Platform options (TBD):
- Public Google Sheet (simplest)
- Airtable (better filtering/views)
- GitHub repo with CSV (most open)
- Custom simple web form → database