510(k) · Cleared
ClearedXpert VanA Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cepheid · NIJ System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species
Cleared on Dec 17, 2009 as substantially equivalent to K061686 (Geneohm Sciences Canada, Inc., 2006) and 1 other predicate after an 84-day review. Its family tree reaches back 2 generations to 1997. 8 later devices descend from it.
- Decided
- Dec 17, 2009
- Review
- 84 days
- Class
- Class II
- Product code
- NIJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K972359 (1997). 8 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK972359 Remel Bile Esculin Azide Agar W/6 MCG/ML VancomycinRemel, L.P. · 1997 · Recalled
- 1 generation backK061686 Idi-Vanr AssayGeneohm Sciences Canada, Inc. · 2006
- This deviceK092953 Xpert VanA AssayCepheid · 2009
- Descendant · cites it directly · 6 of its ownK152614 Xpert Carba-RCepheid · 2016
- Descendant · 2 generations on · 3 of its ownK160901 Xpert Carba-RCepheid · 2016
- Descendant · 3 generations on · 1 of its ownK173263 Xpert Carba-RCepheid · 2018
- Descendant · 4 generations on · 0 of its ownK261867 Xpert Carba-RCepheid® · 2026
- Descendant · cites it directly · 0 of its ownK243405 Xpert vanACepheid® · 2024
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K152614Xpert Carba-RCepheid · 2016 · cites it directly6descendants
- K160901Xpert Carba-RCepheid · 2016 · 2 generations on3descendants
- K173263Xpert Carba-RCepheid · 2018 · 3 generations on1descendant
- K261867Xpert Carba-RCepheid® · 2026 · 4 generations on0descendants
- K243405Xpert vanACepheid® · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K972359 | Remel Bile Esculin Azide Agar W/6 MCG/ML Vancomycin | Remel, L.P. | 1997 | 1 |
| −1 | K061686 | Idi-Vanr Assay | Geneohm Sciences Canada, Inc. | 2006 | — |
| 0 (this device) | K092953 | Xpert VanA Assay | Cepheid | 2009 | — |
| +1 | K152614 | Xpert Carba-R | Cepheid | 2016 | — |
| +2 | K160901 | Xpert Carba-R | Cepheid | 2016 | — |
| +3 | K173263 | Xpert Carba-R | Cepheid | 2018 | — |
| +4 | K261867 | Xpert Carba-R | Cepheid® | 2026 | — |
| +1 | K243405 | Xpert vanA | Cepheid® | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K061686 | Idi-Vanr AssaySummary page 1…0 Procode: NIJ Classification Advisory Microbiology Committee: Panel: 83 Predicate Devices: BD IDI-VanRO Assay [5 10(k) #K061686] Remel Esculin Azide Agar w/6ptg/mL vancomycin [5 10(k) #K972359] Device D… | 2006 |
| * | K972359 | Remel Bile Esculin Azide Agar W/6 MCG/ML VancomycinSummary page 1…cate Devices: BD IDI-VanRO Assay [5 10(k) #K061686] Remel Esculin Azide Agar w/6ptg/mL vancomycin [5 10(k) #K972359] Device Description: The Cepheid Xpert vanA Assay is a rapid, automated in vitro diagnostic test for qualitative detection of th… | 1997 |
What descends from it? (8)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 12 years and passes through 3 companies; a new generation was cleared every 9.0 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K152614 (Cepheid, 2016) has gone furthest, with 6 descendants of its own.
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. 2009, this device’s year, is highlighted.
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 Cepheid Xpert® vanA Assay performed in the GeneXpert® Dx System is a qualitative in vitro diagnostic test designed for rapid detection of the vanA gene sequence associated with vancomycin resistance in bacteria obtained from rectal swab specimens from patients at risk for intestinal colonization with vancomycin-resistant bacteria. The test utilizes automated real-time polymerase chain reaction (PCR) to detect the vanA gene that is frequently…
Read the full statement (136 words)
The Cepheid Xpert® vanA Assay performed in the GeneXpert® Dx System is a qualitative in vitro diagnostic test designed for rapid detection of the vanA gene sequence associated with vancomycin resistance in bacteria obtained from rectal swab specimens from patients at risk for intestinal colonization with vancomycin-resistant bacteria. The test utilizes automated real-time polymerase chain reaction (PCR) to detect the vanA gene that is frequently associated with vancomycin-resistant enterococci (VRE). The Xpert vanA Assay is intended to aid in the recognition, prevention, and control of vancomycin-resistant organisms that colonize patients in healthcare settings. The Xpert vanA Assay is not intended to diagnose infections caused by vancomycin-resistant bacteria nor to guide or monitor treatment for vancomycin-resistant bacterial infections. Concomitant cultures are necessary to recover organisms for identification of vancomycin-resistant bacteria, antimicrobial susceptibility testing and for epidemiological typing
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092953 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092953: Xpert VanA Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092953
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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