# DEN040011: Amplichip CYP450 Test, Model 04381866190

- Pathway: De Novo (Post-NSE)
- Applicant: Roche Molecular Systems, Inc.
- Decided: Dec 23, 2004 after 3 days
- Product code: NTI (Drug Metabolizing Enzyme Genotyping Systems)
- Device class: 2
- Regulation: 21 CFR 862.3360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K043576: Roche Amplichip CYP450 Test (2005), 8 descendants of its own
- K073014: Infiniti 2C9 & VKORC1 Multiplex Assay for Warfarin (2008), 4 descendants of its own
- K101683: Infiniti CYP2C19 Assay (2010), 3 descendants of its own
- K051824: Invader UGT1A1 Molecular Assay (2005), 2 descendants of its own
- K123891: Spartan RX CYP2C19 Test System (2013), 1 descendant of its own

Source page: https://510kreport.com/device/DEN040011
Methodology: https://510kreport.com/methodology