# NHT: Assay, Nucleic Acid Amplification, Bacillus Anthracis

- Device class: 2; regulation: 21 CFR 866.3045; FDA's rule: 510(k) required
- FDA decisions: 7
- 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)
- 2005: 1
- 2007: 2
- 2013: 1
- 2014: 1
- 2019: 1
- 2026: 1

## Most-cited predicates
- K051713: Jbaids Anthrac Detection System (2005), cited by 3
- K071188: Modification to Jbaids Anthrax Detection System (2007), cited by 2
- K072631: Jbaids Plaque Detection Kit, Model JRPD-Asy-0123 (2007), cited by 1
- K140426: Anthracis Real-Time PCR Assay (2014), cited by 1

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