510(k) Report

De Novo · Granted

Granted

Xtag Gastrointestinal Pathogen Panel (GPP) Xtag Data Analysis Software for GPP (Tdas)

DEN130003De NovoGranted Jan 14, 20133-day reviewClass II21 CFR 866.3990

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. · PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System

Granted on Jan 14, 2013 as a new device type through De Novo after a 3-day review. 33 later devices descend from it.

Decided
Jan 14, 2013
Review
3 days
Class
Class II
Product code
PCH
Recalls
None

33 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2014: 4 descendants cleared2018: 3 descendants cleared2013: 1 descendant cleared2015: 2 descendants cleared2025: 8 descendants cleared2024: 3 descendants cleared2016: 2 descendants cleared2026: 3 descendants cleared2019: 2 descendants cleared2022: 3 descendants cleared2017: 1 descendant cleared2023: 1 descendant cleared2010201520202025
  1. This deviceDEN130003 Xtag Gastrointestinal Pathogen Panel (GPP) Xtag Data Analysis…Luminex Molecular Diagnostics, Inc. · 2013
  2. Descendant · cites it directly · 24 of its ownK140407 Filmarray Gastrointestinal (GI) PanelBiofire Diagnostics · 2014 · Recalled
  3. Descendant · 2 generations on · 12 of its ownK143005 FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0Biofire Diagnostics, LLC · 2015 · Recalled
  4. Descendant · 3 generations on · 9 of its ownK160459 FilmArray Gastrointestinal Panel (GI) for use with FilmArray TorchBiofire Diagnostics, LLC · 2016 · Recalled
  5. Descendant · 2 generations on · 4 of its ownK220062 QIAstat-Dx Gastrointestinal Panel 2QIAGEN GmbH · 2024
  6. Descendant · cites it directly · 4 of its ownK123274 Progastro SSCS AssayGen-Probe Prodesse, Inc. · 2013

Showing 5 of 33 descendants. See all descendants

Descendants cleared per year

2013: 12014: 42015: 22016: 22017: 12018: 32019: 22022: 32023: 12024: 32025: 82026: 3
2013high 8 (2025) · low 0 (2020)2026

Most influential descendants

Showing 5 of 33 · See all
  • K140407Filmarray Gastrointestinal (GI) PanelBiofire Diagnostics · 2014 · cites it directly24descendants
  • K143005FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0Biofire Diagnostics, LLC · 2015 · 2 generations on12descendants
  • K160459FilmArray Gastrointestinal Panel (GI) for use with FilmArray TorchBiofire Diagnostics, LLC · 2016 · 3 generations on9descendants
  • K220062QIAstat-Dx Gastrointestinal Panel 2QIAGEN GmbH · 2024 · 2 generations on4descendants
  • K123274Progastro SSCS AssayGen-Probe Prodesse, Inc. · 2013 · cites it directly4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)DEN130003Xtag Gastrointestinal Pathogen Panel (GPP) Xtag Data Analysis Software for GPP…Luminex Molecular Diagnostics, Inc.2013—
+1K140407Filmarray Gastrointestinal (GI) PanelBiofire Diagnostics20148
+2K143005FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0Biofire Diagnostics, LLC20157
+3K160459FilmArray Gastrointestinal Panel (GI) for use with FilmArray TorchBiofire Diagnostics, LLC20166
+2K220062QIAstat-Dx Gastrointestinal Panel 2QIAGEN GmbH2024—
+1K123274Progastro SSCS AssayGen-Probe Prodesse, Inc.2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201440
201520
201620
201710
201830
201920
202230
202310
202430
202580
202630
FIG. 1 — Lineage of DEN130003, 2013–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

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

Planning a device in PCH? 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 PCH device

  1. #1 K220062 QIAstat-Dx Gastrointestinal Panel 2score 16.7 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

Does it have a predicate?

De Novo decisions do not claim a predicate device.

What descends from it? (33)

See all 33

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K140407Filmarray Gastrointestinal (GI) PanelBiofire Diagnostics201424
K123274Progastro SSCS AssayGen-Probe Prodesse, Inc.20134
K180041BioCode Gastrointestinal Pathogen Panel (GPP)Applied BioCode, Inc.20182
K142033Verigene Enteric Pathogen Nucleic Acid Test (EP)Nanospere,Inc.20140
K140377Xtag Gastrointestinal Pathogen Panel (GPP)/Xtag Data Analysis Software for GPP (Tdas GPP)Luminex Molecular Diagnostics, Inc.20140

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K140407 (Biofire Diagnostics, 2014) has gone furthest, with 24 descendants of its own.

How does its category compare?

All PCH devices

PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · PCH

7in 2025

2013: 32014: 62015: 22016: 22017: 12018: 42019: 42022: 22023: 12024: 32025: 72026 (partial year): 3
2007high 7 (2025) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PCH

89in 2025

2014: 120 days median2018: 105 days median2019: 191 days median2024: 271 days median2025: 89 days median2026 (partial year): 176 days median
2007high 271 (2024) · low 89 (2025)2026

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

Recalls per year · PCH

5in 2025

2023: 12025: 5
2007high 5 (2025) · low 0 (2007)2026

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

Adverse event reports per year · PCH

40in 2025

2014: 12019: 42021: 262022: 472023: 622024: 452025: 40
2007high 62 (2023) · low 0 (2007)2025

MAUDE reports naming product code PCH, 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—00
20080—00
20090—00
20100—00
20110—00
20120—00
20133—00
2014612001
20152—00
20162—00
20171—00
2018410500
2019419104
20200—00
20210—026
20222—047
20231—162
20243271045
2025789540
202631760—

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 PCH

The PCH category page

  • K253722LIAISON PLEX Gastrointestinal Flex AssayLuminex Corporation · 2026
  • K254032QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini BQIAGEN GmbH · 2026
  • K251721Xpert GI PanelCepheid · 2026
  • K252329QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini BQIAGEN GmbH · 2025
  • K251993Panther Fusion GI Expanded Bacterial AssayHologic, Inc. · 2025

https://510kreport.com/device/DEN130003 · printed Nov 6, 2026

Cite this page

510(k) Report. “DEN130003: Xtag Gastrointestinal Pathogen Panel (GPP) Xtag Data Analysis Software for GPP (Tdas).” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN130003

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026