510(k) · Cleared

Cleared

Xpert vanA

K243405510(k) SpecialCleared Nov 21, 202420-day reviewClass II21 CFR 866.1640

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cepheid® · NIJ System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species

Cleared on Nov 21, 2024 as substantially equivalent to K092953 (Cepheid, 2009) after a 20-day review. Its family tree reaches back 3 generations to 1997.

Decided: Nov 21, 2024
Review: 20 days
Class: Class II
Product code: NIJ
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K972359 (1997). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK972359 Remel Bile Esculin Azide Agar W/6 MCG/ML VancomycinRemel, L.P. · 1997 · Recalled
2 generations backK061686 Idi-Vanr AssayGeneohm Sciences Canada, Inc. · 2006
1 generation backK092953 Xpert VanA AssayCepheid · 2009
This deviceK243405 Xpert vanACepheid® · 2024

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K972359	Remel Bile Esculin Azide Agar W/6 MCG/ML Vancomycin	Remel, L.P.	1997	1
−2	K061686	Idi-Vanr Assay	Geneohm Sciences Canada, Inc.	2006	—
−1	K092953	Xpert VanA Assay	Cepheid	2009	—
0 (this device)	K243405	Xpert vanA	Cepheid®	2024	—

FIG. 1 — Lineage of K243405, 1997–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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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	Applicant	Decided	Recalls
*	K092953	Xpert VanA Assay Summary page 6 …oduct code: NIJ, OOI Classification Microbiology (83) Advisory Panel Prescription Use Yes Predicate Device Xpert vanA Assay (K092953) 510(k) Summary Page 3 of 8 Xpert® van…	Cepheid	2009	—

Also cleared against K092953: 1 other device →

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 27 years and passes through 4 companies; a new generation was cleared every 9.0 years on median.
1 of the 3 ancestors has a recall of any class.
1 other device also cites its predicate K092953.

How does its category compare?

All NIJ devices

NIJ System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.

FDA decisions per year · NIJ

1in 2024

2007high 1 (2009) · low 0 (2007)2026

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	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	1	—	0
2010	0	—	0
2011	1	—	0
2012	0	—	0
2013	1	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	1	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

Read the full statement (134 words)

The Xpert® vanA test performed on the GeneXpert® Instrument Systems is a qualitative in vitro diagnostic test designed for 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 test is intended to aid in the recognition, prevention, and control of vancomycin-resistant organisms that colonize patients in healthcare settings. The Xpert vanA test 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K243405 · printed Nov 6, 2026

Cite this page

510(k) Report. “K243405: Xpert vanA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243405

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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