# OJN: Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test

- Device class: 3; regulation: 21 CFR —; FDA's rule: PMA required
- FDA decisions: 1
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2009: 1
- 2010: 3
- 2011: 2
- 2012: 2
- 2013: 2
- 2020: 3
- 2021: 2
- 2023: 4
- 2024: 3
- 2025: 4

## Most-cited predicates

Source page: https://510kreport.com/product-code/OJN
Data by year (CSV): https://510kreport.com/product-code/OJN.csv