xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)
FDA 510(k) K183023 · Luminex Molecular Diagnostics, Inc.
Submission
- Device name
- xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)
- Applicant
- Luminex Molecular Diagnostics, Inc.
Toronto, CA - Received
- November 1, 2018
- Decision date
- November 30, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- PCH – Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3990
- Specialty
- Microbiology
A gastrointestinal pathogen panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple gastrointestinal microbial nucleic acids extracted from human stool specimens. The detection and identification of a specific gastrointestinal microbial nucleic acid from individuals exhibiting signs and/or symptoms of gastrointestinal…
Other 510(k)s with product code PCH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253722 | LIAISON PLEX Gastrointestinal Flex AssayPCH · Traditional | Luminex Corporation | 05/19/2026SE |
| K254032 | QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel…PCH · Traditional | QIAGEN GmbH | 03/09/2026SE |
| K251721 | Xpert GI PanelPCH · Traditional | Cepheid | 01/16/2026SE |
| K252329 | QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel…PCH · Traditional | QIAGEN GmbH | 10/22/2025SE |
| K251993 | Panther Fusion GI Expanded Bacterial AssayPCH · Traditional | Hologic, Inc. | 09/25/2025SE |
| K251868 | Panther Fusion GI Bacterial AssayPCH · Traditional | Hologic | 09/25/2025SE |
| K250324 | QIAstat-Dx GI Panel 2 Mini BPCH · Special | QIAGEN GmbH | 02/28/2025SE |
| K243885 | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel MidPCH · Special | Biofire Diagnostics, LLC | 01/16/2025SE |
| K242877 | BioCode Gastrointestinal Pathogen Panel (GPP)PCH · Traditional | Applied BioCode, Inc. | 01/10/2025SE |
| K243813 | QIAstat-Dx GI Panel 2 Mini B&VPCH · Special | QIAGEN GmbH | 01/08/2025SE |
More from QIAGEN GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K242613 | NxTAG® Respiratory Pathogen PanelOCC · Special | 10/02/2024SE |
| K231758 | NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2)QOF · Traditional | 03/11/2024SE |
| K193167 | NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT SoftwareOCC · Special | 12/11/2019SE |
| K191161 | xTAG Gastrointestinal Pathogen Panel (GPP)PCH · Special | 11/12/2019SE |
| K191160 | xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)PCH · Special | 11/04/2019SE |
| K183030 | xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)PCH · Special | 11/30/2018SE |
| K170492 | xTAG CYP2D6 Kit v3NTI · Special | 08/11/2017SE |
| K163347 | xTAG Cystic Fibrosis 39 Kit v2NUA · Special | 12/15/2016SESK |
| K163336 | xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTRNUA · Special | 12/15/2016SESK |
| K152386 | NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT SoftwareOCC · Traditional | 12/17/2015SE |
Questions and answers
When was xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) cleared by the FDA?
xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) (K183023) received a 510(k) decision of Substantially Equivalent on November 30, 2018, 29 days after the submission was received.
What is the product code of K183023?
The FDA product code is PCH – Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System, a Class II (moderate risk) device regulated under 21 CFR 866.3990.