# DEN130003: Xtag Gastrointestinal Pathogen Panel (GPP) Xtag Data Analysis Software for GPP (Tdas)

- Pathway: De Novo (Post-NSE)
- Applicant: Luminex Molecular Diagnostics, Inc.
- Decided: Jan 14, 2013 after 3 days
- Product code: PCH (Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System)
- Device class: 2
- Regulation: 21 CFR 866.3990
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
33 later devices descend from it; 5 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K140407: Filmarray Gastrointestinal (GI) Panel (2014), 24 descendants of its own
- K143005: FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0 (2015), 12 descendants of its own
- K160459: FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch (2016), 9 descendants of its own
- K220062: QIAstat-Dx Gastrointestinal Panel 2 (2024), 4 descendants of its own
- K123274: Progastro SSCS Assay (2013), 4 descendants of its own

Source page: https://510kreport.com/device/DEN130003
Methodology: https://510kreport.com/methodology