# K142501: Xpert Norovirus, GeneXpert Dx Systems (GX-I, GX-11, GX-IV, GX-XVI), GeneXpert Infinity-48 System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System

- Pathway: 510(k) (Traditional)
- Applicant: Cepheid
- Decided: Nov 26, 2014 after 82 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
Longest line of descent: 1 generation back to K121894 (2013). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121894: Xtag Gastrointestinal Pathogen Panel (GPP) Xtag Data Analysis Software for GPP (Tdas GPP) Luminex Magpix, Luminex Molecular Diagnostics, Inc. (2013) Summary page 4.

## Most influential descendants
- K171511: RIDA GENE Norovirus GI/GII (2017), 0 descendants of its own

## Indications for use
The Cepheid Xpert Norovirus Assay, performed on the GeneXpert® Instrument Systems, is a qualitative in vitro diagnostic test for the identification and differentiation of norovirus genogroup I and genogroup II RNA from raw or unpreserved unformed stool specimens collected from individuals with symptoms of acute gastroenteritis. The test utilizes automated real-time reverse transcriptase polymerase chain reaction (RT-PCR) to detect norovirus RNA. The Xpert Norovirus Assay is intended to aid in the diagnosis of norovirus infections when used in conjunction with clinical evaluation, laboratory findings, and epidemiological information. The assay also aids in the detection and identification of norovirus infections in the context of outbreaks.

Source page: https://510kreport.com/device/K142501
Methodology: https://510kreport.com/methodology