# K043576: Roche Amplichip CYP450 Test

- Pathway: 510(k) (Traditional)
- Applicant: Roche Molecular Systems, Inc.
- Decided: Jan 10, 2005 after 14 days
- Product code: NTI (Drug Metabolizing Enzyme Genotyping Systems)
- Device class: 2
- Regulation: 21 CFR 862.3360
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN040011 (2004). 1 ancestor in all.
8 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN040011: Amplichip CYP450 Test, Model 04381866190, Roche Molecular Systems, Inc. (2004). Our reading of the summary gave K042259, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN040011, Amplichip CYP450 Test, Model 04381866190 (Roche Molecular Systems, Inc.), granted Dec 23, 2004; older De Novo requests were first filed under a 510(k) number, so this links to the grant.

## Most influential descendants
- 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
- K070804: Verigene System, Verigene Warfarin Metabolism Nucleic Acid Test (2007), 1 descendant of its own

## Recalls of this device
- Mar 9, 2007 · Not classified · Z-0734-2007: The current package insert for the AmpliChip CYP 450 test, lists an incorrect part number for DNase I. The DNase is listed in the "Other Materials Required" section as 'DNase I rec., RNase-free, P/N 0

## Indications for use
The Roche AmpliChip CYP450 test is intended to identify a patient's CYP2C19 genotype from genomic DNA extracted from a whole blood sample. Information about CYP2C19 genotype may be used as an aid to clinicians in determining therapeutic strategy and treatment dose for therapeutics that are metabolized by the CYP2C19 gene product.

Source page: https://510kreport.com/device/K043576
Methodology: https://510kreport.com/methodology