# NTM: Antigen, Inflammatory Response Marker, Sepsis

- Device class: 2; regulation: 21 CFR 866.3210; FDA's rule: 510(k) required
- FDA decisions: 3
- Recalls: 1 (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)
- 2005: 1
- 2007: 1
- 2008: 1

## Most-cited predicates
- K071146: Vidas B.R.a.H.M.S. PCT Assay (2007), cited by 2
- K040887: B-R-a-H-M-S PCT Lia (2005), cited by 1
- K070310: B R a H M S PCT Sensitive Kryptor Test System (2008), cited by 1

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