510(k) · Cleared
ClearedIdi-Vanr Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Geneohm Sciences Canada, Inc. · NIJ System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species
Cleared on Aug 30, 2006 as substantially equivalent to K972359 (Remel, L.P., 1997) after a 76-day review. Its family tree reaches back 1 generation to 1997. 9 later devices descend from it.
- Decided
- Aug 30, 2006
- Review
- 76 days
- Class
- Class II
- Product code
- NIJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K972359 (1997). 9 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK972359 Remel Bile Esculin Azide Agar W/6 MCG/ML VancomycinRemel, L.P. · 1997 · Recalled
- This deviceK061686 Idi-Vanr AssayGeneohm Sciences Canada, Inc. · 2006
- Descendant · cites it directly · 8 of its ownK092953 Xpert VanA AssayCepheid · 2009
- Descendant · 2 generations on · 6 of its ownK152614 Xpert Carba-RCepheid · 2016
- Descendant · 3 generations on · 3 of its ownK160901 Xpert Carba-RCepheid · 2016
- Descendant · 4 generations on · 1 of its ownK173263 Xpert Carba-RCepheid · 2018
- Descendant · 5 generations on · 0 of its ownK261867 Xpert Carba-RCepheid® · 2026
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K092953Xpert VanA AssayCepheid · 2009 · cites it directly8descendants
- K152614Xpert Carba-RCepheid · 2016 · 2 generations on6descendants
- K160901Xpert Carba-RCepheid · 2016 · 3 generations on3descendants
- K173263Xpert Carba-RCepheid · 2018 · 4 generations on1descendant
- K261867Xpert Carba-RCepheid® · 2026 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K972359 | Remel Bile Esculin Azide Agar W/6 MCG/ML Vancomycin | Remel, L.P. | 1997 | 1 |
| 0 (this device) | K061686 | Idi-Vanr Assay | Geneohm Sciences Canada, Inc. | 2006 | — |
| +1 | K092953 | Xpert VanA Assay | Cepheid | 2009 | — |
| +2 | K152614 | Xpert Carba-R | Cepheid | 2016 | — |
| +3 | K160901 | Xpert Carba-R | Cepheid | 2016 | — |
| +4 | K173263 | Xpert Carba-R | Cepheid | 2018 | — |
| +5 | K261867 | Xpert Carba-R | Cepheid® | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 1 | 0 |
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 NIJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NIJ device
- #1 K243405 Xpert vanAscore 9.0 · 3 generations · no Class I recall
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 |
|---|---|---|---|
| * | K972359 | Remel Bile Esculin Azide Agar W/6 MCG/ML VancomycinSummary page 1…esistant Bacteria, Direct Specimen Predicate Device: Remel Bile Esculin Azide agar with 6 ug/mL vancomycin (BEAV) (K972359) Device Description: Intended Use: The IDI-VanR® Assay is a qualitative in vitro test for the rapid detection of vancomyc… | 1997 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092953 | Xpert VanA Assay | 2009 | 8 |
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?
How does its category compare?
All NIJ devicesNIJ System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NIJ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · NIJ
Too few NIJ 510(k)s in any year since 2007 to give a median.
Recalls per year · NIJ
No recall names NIJ since 2007.
Adverse event reports per year · NIJ
No MAUDE report names NIJ 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 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 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 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The IDI-VanR® Assay is a qualitative in vitro test for the rapid detection of vancomycin-resistance (vanA and vanB) genes directly from rectal swabs. The IDI-vanR® Assay detects the presence of the vanA and vanB genes that can be associated with vancomycin-resistant enterococci (VRE). The assay is performed on an automated real-time PCR instrument with rectal swabs from patients at risk for VRE colonization. The IDl-VanR® Assay can be used as an aid to…
Read the full statement (118 words)
The IDI-VanR® Assay is a qualitative in vitro test for the rapid detection of vancomycin-resistance (vanA and vanB) genes directly from rectal swabs. The IDI-vanR® Assay detects the presence of the vanA and vanB genes that can be associated with vancomycin-resistant enterococci (VRE). The assay is performed on an automated real-time PCR instrument with rectal swabs from patients at risk for VRE colonization. The IDl-VanR® Assay can be used as an aid to identify, prevent and control vancomycin-resistant colonization in healthcare settings. Concomitant cultures are necessary to recover organisms for epidemiological typing, susceptibility testing and for further confirmatory identification. The IDI-VanR® Assay is not intended to diagnose VRE infections nor to guide or monitor treatment for VRE infections.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061686 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061686: Idi-Vanr Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061686
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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