# K171511: RIDA GENE Norovirus GI/GII

- Pathway: 510(k) (Traditional)
- Applicant: R-Biopharm AG
- Decided: Aug 21, 2017 after 89 days
- Product code: PIQ (Reagents For Detection Of Norovirus Nucleic Acid)
- 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: 2 generations back to K121894 (2013). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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, Cepheid (2014) Summary page 4.

## Indications for use
The RIDA®GENE Norovirus GI/GII assay, performed on the Applied Biosystems® 7500 Fast Dx System, is a real-time RT-PCR in vitro diagnostic test for the qualitative detection and differentiation of norovirus genogroup I (GI) and II (GII) RNA from raw or unpreserved stool specimens collected from individuals with signs and symptoms of acute gastroenteritis. The RIDA®GENE Norovirus GI/GII assay is intended for use as an aid in the differential diagnosis of norovirus genogroup I and II infections in patients symptomatic for gastroenteritis in conjunction with clinical evaluation, laboratory findings, and epidemiological information. The assay aids in the detection and identification of norovirus infections as the cause of acute gastroenteritis in sporadic cases as well as in the context of outbreaks. Negative results do not preclude a norovirus infection and should not be used as the sole basis for diagnosis.

Source page: https://510kreport.com/device/K171511
Methodology: https://510kreport.com/methodology