PB&J

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

Event

NextGen BioAgents Hackathon - NYTechWeek

Award

Winner — Nucleate

Third Place

Links

Repository

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

Website

nextgen-bioagents-hackathon-2026.streamlit.app

Demo video

youtu.be/MI3TOhdBtPA

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.