# K123891: Spartan RX CYP2C19 Test System

- Pathway: 510(k) (Abbreviated)
- Applicant: Spartan Bioscience, Inc.
- Decided: Aug 12, 2013 after 237 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: 4 generations back to DEN040011 (2004). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101683: Infiniti CYP2C19 Assay, Autogenomics, Incorporated (2010) Summary page 1.

## Most influential descendants
- K220026: Genomadix Cube CYP2C19 System (2023), 0 descendants of its own

## Indications for use
Assay - The Spartan RX CYP2C19 System is indicated for use as an aid to clinicians in determining therapeutic strategies for therapeutics that are metabolized by the Cytochrome P450 2C19 gene product, and that are specifically affected by the *2, *3, and *17 alleles. The Spartan RX CYP2C19 Assay will be run on the Spartan RX Platform from the buccal sample collected with a buccal swab. The Spartan RX CYP2C19 Assay is not indicated to be used to predict drug response or non-response. Platform - The Spartan RX CYP2C19 System is indicated for use as an aid to clinicians in determining therapeutic strategies for therapeutics that are metabolized by the Cytochrome P450 2C19 gene product, and that are specifically affected by the *2, *3, and *17 alleles. The Spartan RX CYP2C19 Platform will be used to run the Spartan RX CYP2C19 Assay.

Source page: https://510kreport.com/device/K123891
Methodology: https://510kreport.com/methodology