# NTI: Drug Metabolizing Enzyme Genotyping Systems

- Device class: 2; regulation: 21 CFR 862.3360; FDA's rule: 510(k) required
- FDA decisions: 11
- 510(k) review time 2021–2025: median 440 days (middle half 440–440)
- Recalls: 3 (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)
- 2004: 1
- 2005: 2
- 2010: 2
- 2012: 1
- 2013: 3
- 2017: 1
- 2023: 1

## Most-cited predicates
- K043576: Roche Amplichip CYP450 Test (2005), cited by 3
- DEN040011: Amplichip CYP450 Test, Model 04381866190 (2004), cited by 2
- K101683: Infiniti CYP2C19 Assay (2010), cited by 2
- K123891: Spartan RX CYP2C19 Test System (2013), cited by 1
- K051824: Invader UGT1A1 Molecular Assay (2005), cited by 1

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