# K220026: Genomadix Cube CYP2C19 System

- Pathway: 510(k) (Abbreviated)
- Applicant: Genomadix, Inc.
- Decided: Mar 21, 2023 after 440 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
Longest line of descent: 5 generations back to DEN040011 (2004). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123891: Spartan RX CYP2C19 Test System, Spartan Bioscience, Inc. (2013) Summary page 4.

## Indications for use
The Genomadix Cube CYP2C19 System is a qualitative in vitro diagnostic test for the identification of a patient’s CYP2C19 *2, *3, and *17 genotypes determined from genomic DNA obtained from a buccal swab sample. The Genomadix Cube CYP2C19 System can be used to aid clinicians in determining therapeutic strategy for therapeutics that are metabolized by the cytochrome P450 2C19 gene product, specifically *2, *3, and *17 alleles. This test is not intended to be used to predict drug response or non-response. The Genomadix Cube CYP2C19 Test Kit is indicated for use with the Genomadix Cube CYP2C19 Platform.

Source page: https://510kreport.com/device/K220026
Methodology: https://510kreport.com/methodology