510(k) · Cleared
ClearedRIDA GENE Norovirus GI/GII
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
R-Biopharm AG · PIQ Reagents For Detection Of Norovirus Nucleic Acid
Cleared on Aug 21, 2017 as substantially equivalent to K142501 (Cepheid, 2014) after an 89-day review. Its family tree reaches back 2 generations to 2013.
- Decided
- Aug 21, 2017
- Review
- 89 days
- Class
- Class II
- Product code
- PIQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K121894 (2013). No later device cites it as a predicate yet.
- Root · 2 generations backK121894 Xtag Gastrointestinal Pathogen Panel (GPP) Xtag Data Analysis…Luminex Molecular Diagnostics, Inc. · 2013
- 1 generation backK142501 Xpert Norovirus, GeneXpert Dx Systems (GX-I, GX-11, GX-IV, GX-XVI)…Cepheid · 2014
- This deviceK171511 RIDA GENE Norovirus GI/GIIR-Biopharm AG · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K121894 | Xtag Gastrointestinal Pathogen Panel (GPP) Xtag Data Analysis Software for GPP… | Luminex Molecular Diagnostics, Inc. | 2013 | — |
| −1 | K142501 | Xpert Norovirus, GeneXpert Dx Systems (GX-I, GX-11, GX-IV, GX-XVI), GeneXpert… | Cepheid | 2014 | — |
| 0 (this device) | K171511 | RIDA GENE Norovirus GI/GII | R-Biopharm AG | 2017 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PIQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K142501 | Xpert Norovirus, GeneXpert Dx Systems (GX-I, GX-11, GX-IV, GX-XVI), GeneXpert…Summary page 4…trointestinal microorganism multiplex nucleic acid - based assay Product code: PIQ, OOI Predicate device: Cepheid Xpert® Norovirus; (K142501) Page 1 of 11 Device Description The RIDA®GENE Norovirus GI/GII assay, performed… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All PIQ devicesPIQ Reagents For Detection Of Norovirus Nucleic Acid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · PIQ
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · PIQ
Too few PIQ 510(k)s in any year since 2007 to give a median.
Recalls per year · PIQ
No recall names PIQ since 2007.
Adverse event reports per year · PIQ
No MAUDE report names PIQ since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (138 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171511 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171511: RIDA GENE Norovirus GI/GII.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171511
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026