510(k) · Cleared

Cleared

Imdx Vanr for Abbott M2000

K123753510(k) TraditionalCleared Jul 17, 2013223-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

Intelligent Medical Devices, Inc. · NIJ System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species

Cleared on Jul 17, 2013 as substantially equivalent to K102416 (Bd Diagnostics Science, 2011) after a 223-day review. Its family tree reaches back 2 generations to 1997.

Decided: Jul 17, 2013
Review: 223 days
Class: Class II
Product code: NIJ
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K972359 (1997). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK972359 Remel Bile Esculin Azide Agar W/6 MCG/ML VancomycinRemel, L.P. · 1997 · Recalled
1 generation backK102416 BD Geneohm Vanr AssayBd Diagnostics Science · 2011
This deviceK123753 Imdx Vanr for Abbott M2000Intelligent Medical Devices, Inc. · 2013

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	K102416	BD Geneohm Vanr Assay	Bd Diagnostics Science	2011	—
0 (this device)	K123753	Imdx Vanr for Abbott M2000	Intelligent Medical Devices, Inc.	2013	—

FIG. 1 — Lineage of K123753, 1997–2013Source: 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.

Top candidate predicates for a new NIJ device

#1 K243405 Xpert vanAscore 9.0 · 3 generations · no Class I recall

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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
*	K102416	BD Geneohm Vanr Assay Summary page 2 …epidemiology typing and confirmation testing. Substantial Euuivalencv The IMDx VanR for Abbott m2000 assay is substantially equivalent to the BD GeneOhmTM VanR Assay (K 102416). Table 1 compares the characteristics of the IMDx VanR for mn2000 assay (New Device) and the GeneOhni assay (Predicate Device).…	Bd Diagnostics Science	2011	—

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 16 years and passes through 3 companies; a new generation was cleared every 14.1 years on median.
1 of the 2 ancestors has a recall of any class.

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. 2013, 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 (138 words)

The IMDx VanR for Abbott m2000 assay is an in vitro diagnostic assay that uses polymerase chain reaction (PCR) amplification for the qualitative detection of nucleic acids encoding the vancomycin resistance genes vanA4 and/or vanB. The assay is performed directly on human peni-rectal swabs, rectal swabs, or stool specimens from patients at risk for Vancomycin-Resistant Enterococcus (VRE) colonization. The IMDx VanR for Abbott m2000 assay detects the presence of vanA4 and vanE genes that can be associated with vancomycin-resistant enterococci. The IMDx VanR for Abbott m2000 assay can be used as an aid to identify, prevent and control vancomycin-resistant colonization in healthcare settings. The IMDx VanR for Abbott m2000 assay is not intended to diagnose VRE infection nor to guide or monitor treatment of infection. Culture methods are necessary to recover organisms for epidemiology typing and confirmation testing.

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/K123753 · printed Nov 6, 2026

Cite this page

510(k) Report. “K123753: Imdx Vanr for Abbott M2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123753

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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