xTAG CYP2D6 Kit v3

K170492 · Luminex Molecular Diagnostics, Inc. · NTI · Aug 11, 2017 · Clinical Toxicology

Device Facts

• Record ID: K170492
• Device Name: xTAG CYP2D6 Kit v3
• Applicant: Luminex Molecular Diagnostics, Inc.
• Product Code: NTI · Clinical Toxicology
• Decision Date: Aug 11, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.3360
• Device Class: Class 2

Indications for Use

The xTAG CYP2D6 Kit v3 is an in vitro nucleic acid test for the detection of 17 CYP2D6 variants in genomic DNA extracted from human whole blood. The test is intended to be used as an aid to clinicians in determining therapeutic strategy for therapeutics that are metabolized by the CYP2D6 gene product. The xTAG CYP2D6 Kit v3 is not indicated for use in the diagnosis of CYP2D6-related disorders or for the prediction of drug response in patients who have not been prescribed these medications.

Device Story

The xTAG CYP2D6 Kit V3 is an in vitro diagnostic device used for the genotyping of the CYP2D6 gene. It utilizes molecular diagnostic techniques to identify specific genetic variants associated with drug metabolism. The device is intended for use by trained laboratory personnel in a clinical laboratory setting. It processes patient samples to provide genotype information, which assists healthcare providers in understanding a patient's potential drug-metabolizing enzyme activity. This information can inform clinical decision-making regarding medication selection and dosing, potentially improving therapeutic outcomes and reducing adverse drug reactions.

Clinical Evidence

Bench testing only. Verification and validation activities performed to assess impact of enzyme replacement and threshold modifications. Risk analysis conducted to evaluate device modifications.

Technological Characteristics

The device is a drug metabolizing enzyme genotyping system (Product Code: NTI) regulated under 21 CFR 862.3360. It functions as an in vitro diagnostic test for genetic analysis.

Indications for Use

Indicated for use as an aid to clinicians in determining therapeutic strategy for medications metabolized by the CYP2D6 gene product. Detects 17 CYP2D6 variants in genomic DNA from human whole blood. Not for diagnosis of CYP2D6-related disorders or predicting drug response in patients without prescribed medications.

Regulatory Classification

Identification

A drug metabolizing enzyme genotyping system is a device intended for use in testing deoxyribonucleic acid (DNA) extracted from clinical samples to identify the presence or absence of human genotypic markers encoding a drug metabolizing enzyme. This device is used as an aid in determining treatment choice and individualizing treatment dose for therapeutics that are metabolized primarily by the specific enzyme about which the system provides genotypic information.

Special Controls

The special control is FDA's guidance document entitled "Class II Special Controls Guidance Document: Drug Metabolizing Enzyme Genotyping System."

*Classification.* Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Drug Metabolizing Enzyme Genotyping Test System.” See § 862.1(d) for the availability of this guidance document.

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification OIR Decision Memorandum

To: THE FILE

RE: DOCUMENT NUMBER K170492

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.) xTAG CYP2D6 Kit v3, k130189

2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).

3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for

i. Replacing the Platinum Tfi Enzyme System with the TaKaRa Titanium Taq SP DNA Polymerase (TiTaq)
ii. Modifying the negative control threshold for the 2549A>del (*3) variation
iii. Modifying the duplication (DUP) and not detected (ND) call thresholds
iv. Modification to software allelic ratio (AR) threshold values
v. Addition of 124G>A SNP to the *5/*5 (homozygous deletion) exemption list
vi. Changes to device labeling to include updated information related to allele frequency and background information related to genotype-phenotype correlations

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical and technological characteristics.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.