xTAG Gastrointestinal Pathogen Panel (GPP)

• K Number: K191161
• Device Name: xTAG Gastrointestinal Pathogen Panel (GPP)
• Manufacturer: Luminex Molecular Diagnostics, Inc.
• Date Cleared: 2019-11-12 ( 195 days)
• Product Code: PCH
• Regulation Number: 866.3990
• Type: Special
• Panel: MI
• Reference & Predicate Devices: N/A

Intended Use

Not Found

Device Description

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AI/ML Overview

I am sorry, but the provided text from the FDA 510(k) clearance letter for the xTAG Gastrointestinal Pathogen Panel (GPP) does not contain the specific information required to answer your questions about acceptance criteria and the detailed study that proves the device meets those criteria.

The letter primarily confirms the substantial equivalence of the device to a predicate device and outlines regulatory requirements. It does not include:

• A table of acceptance criteria and reported device performance.
• Details about the sample size used for a test set, data provenance, or the number/qualifications of experts.
• Information on adjudication methods, MRMC studies, standalone performance, or the type of ground truth used.
• Details regarding the training set's sample size or ground truth establishment.

To obtain this information, you would typically need to refer to the 510(k) summary document or the full 510(k) submission (if publicly available), which often contain the study design and results for substantial equivalence demonstrations. The letter itself is a notice of clearance, not a comprehensive study report.

Regulation Number and Section

§ 866.3990 Gastrointestinal microorganism multiplex nucleic acid-based assay.

(a)
Identification. A gastrointestinal microorganism multiplex nucleic acid-based assay is a qualitativein vitro diagnostic device intended to simultaneously detect and identify multiple gastrointestinal microbial nucleic acids extracted from human stool specimens. The device detects specific nucleic acid sequences for organism identification as well as for determining the presence of toxin genes. The detection and identification of a specific gastrointestinal microbial nucleic acid from individuals exhibiting signs and symptoms of gastrointestinal infection aids in the diagnosis of gastrointestinal infection when used in conjunction with clinical evaluation and other laboratory findings. A gastrointestinal microorganism multiplex nucleic acid-based assay also aids in the detection and identification of acute gastroenteritis in the context of outbreaks.(b)
Classification. Class II (special controls). The special controls are set forth in FDA's guideline document entitled: “Class II Special Controls Guideline: Gastrointestinal Microorganism Multiplex Nucleic Acid-Based Assays for Detection and Identification of Microorganisms and Toxin Genes from Human Stool Specimens.” For availability of the guideline document, see § 866.1(e).