PB&J

Predicates, Building, and Journey: Building a tool to help navigate 510-K Submissions

NextGen BioAgents Hackathon - NYTechWeekWinner — Third Place

Links

Repository

github.com/antmbraun/NextGen-BioAgents-Hackathon-2026

Website

nextgen-bioagents-hackathon-2026.streamlit.app

Demo video

youtu.be/MI3TOhdBtPA

Additional info

Project Slide Deck Link

docs.google.com/presentation/d/1xq36ySaQd5FdLoFHFyIxBdzolSA-jU0n/edit?usp=sharing&ouid=101897630127098927925&rtpof=true&sd=true

Team

1 member

JA
Jae Lee
Owner

Overview

We built a agent to evaluate potential predicates, generate a ESTAR-ready 510K application, and pre-empt potential FDA inquiries in an effort to save time and costs during development.