510(k) Report

510(k) · Cleared

Recalled · 2011

Xtag CYP2D6 Kit V3, Model I030C0300 (96 Tests/Kit), Tdas CYP2D6 Software (2030-0254)

K093420510(k) TraditionalCleared Aug 26, 2010296-day reviewClass II21 CFR 862.3360Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Luminex Molecular Diagnostics, Inc. · NTI Drug Metabolizing Enzyme Genotyping Systems

Cleared on Aug 26, 2010 as substantially equivalent to DEN040011 (Roche Molecular Systems, Inc., 2004) after a 296-day review. Its family tree reaches back 1 generation to 2004. It has been recalled once.

Decided
Aug 26, 2010
Review
296 days
Class
Class II
Product code
NTI
Recalls
1
Predicates
1

Its longest line of descent runs back 1 generation to DEN040011 (2004). No later device cites it as a predicate yet.

DEN040011 · Amplichip CYP450 Test, Model 04381866190 · Roche Molecular Systems, Inc. · 20042000200220042006200820102012
DEN040011 · Amplichip CYP450 Test, Model 04381866190 · Roche Molecular Systems, Inc. · 20040
  1. Root · 1 generation backDEN040011 Amplichip CYP450 Test, Model 04381866190Roche Molecular Systems, Inc. · 2004
  2. This deviceK093420 Xtag CYP2D6 Kit V3, Model I030C0300 (96 Tests/Kit), Tdas CYP2D6…Luminex Molecular Diagnostics, Inc. · 2010
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1DEN040011Amplichip CYP450 Test, Model 04381866190Roche Molecular Systems, Inc.2004—
0 (this device)K093420Xtag CYP2D6 Kit V3, Model I030C0300 (96 Tests/Kit), Tdas CYP2D6 Software…Luminex Molecular Diagnostics, Inc.2010—
FIG. 1 — Lineage of K093420, 2004–2010Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in NTI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new NTI device

  1. #1 K220026 Genomadix Cube CYP2C19 Systemscore 6.2 · 5 generations · no Class I recall
Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*DEN040011Amplichip CYP450 Test, Model 04381866190
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.
Roche Molecular Systems, Inc.2004—

Also cleared against DEN040011: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
May 24, 2011Not classifiedZ-3112-2011OtherInaccurate test results, due to possible defective primers, which could lead to incorrect dosage on manufactured drug assays.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • 1 other device also cites its predicate DEN040011.

How does its category compare?

All NTI devices

NTI Drug Metabolizing Enzyme Genotyping Systems: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · NTI

1in 2023

2010: 22012: 12013: 32017: 12023: 1
2007high 3 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NTI

116in 2013

2013: 116 days median
2007high 116 (2013)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NTI

1in 2011

2007: 22011: 1
2007high 2 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NTI

2in 2011

2007: 12009: 12010: 12011: 2
2007high 2 (2011) · low 0 (2008)2025

MAUDE reports naming product code NTI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—21
20080—00
20090—01
20102—01
20110—12
20121—00
2013311600
20140—00
20150—00
20160—00
20171—00
20180—00
20190—00
20200—00
20210—00
20220—00
20231—00
20240—00
20250—00
20260—0—

What is it indicated for?

The xTAG® CYP2D6 Kit v3 is a device used to simultaneously detect and identify a panel of nucleotide variants found within the highly polymorphic CYP2D6 gene located on chromosome 22 from genomic DNA extracted from EDTA and citrate anticoagulated whole blood samples. This kit can also identify gene rearrangements associated with the deletion (*5) and duplication genotypes. The xTAG® CYP2D6 Kit v3 is a qualitative genotyping assay which can be used as an…

Read the full statement (113 words)

The xTAG® CYP2D6 Kit v3 is a device used to simultaneously detect and identify a panel of nucleotide variants found within the highly polymorphic CYP2D6 gene located on chromosome 22 from genomic DNA extracted from EDTA and citrate anticoagulated whole blood samples. This kit can also identify gene rearrangements associated with the deletion (*5) and duplication genotypes. The xTAG® CYP2D6 Kit v3 is a qualitative genotyping assay which can be used as an aid to clinicians in determining therapeutic strategy for therapeutics that are metabolized by the CYP2D6 gene product. This kit is not indicated for stand-alone diagnostic purposes. This test is not intended to be used to predict drug response or non-response.

Indications for use as stated in the FDA summary.

Also cleared against DEN040011

1 other device cites the same predicate.

  • K043576Roche Amplichip CYP450 TestRoche Molecular Systems, Inc. · 20051 recall

More from Luminex Molecular Diagnostics, Inc.

26 FDA decisions under this applicant name. See the company

  • K242613NxTAG® Respiratory Pathogen PanelLuminex Molecular Diagnostics, Inc. · 2024
  • K231758NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2)Luminex Molecular Diagnostics, Inc. · 2024
  • K193167NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT SoftwareLuminex Molecular Diagnostics, Inc. · 20191 recall
  • K191161xTAG Gastrointestinal Pathogen Panel (GPP)Luminex Molecular Diagnostics, Inc. · 2019
  • K191160xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)Luminex Molecular Diagnostics, Inc. · 2019

Recent decisions in NTI

The NTI category page

  • K220026Genomadix Cube CYP2C19 SystemGenomadix, Inc. · 2023
  • K170492xTAG CYP2D6 Kit v3Luminex Molecular Diagnostics, Inc. · 2017
  • K131565Xtag CYP2C19 Kit V3Luminex Molecular Diagnostics, Inc. · 2013
  • K123891Spartan RX CYP2C19 Test SystemSpartan Bioscience, Inc. · 2013
  • K130189Xtag CYP2D6 Kit V3 (Including Tdas CYP2D6 Software)Luminex Molecular Diagnostics, Inc. · 2013

https://510kreport.com/device/K093420 · printed Nov 4, 2026

Cite this page

510(k) Report. “K093420: Xtag CYP2D6 Kit V3, Model I030C0300 (96 Tests/Kit), Tdas CYP2D6 Software (2030-0254).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093420

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026