510(k) · Cleared

Cleared

GenePOC Carba

K190275510(k) TraditionalCleared May 10, 201991-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

Genepoc, Inc. · PMY System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony

Cleared on May 10, 2019 as substantially equivalent to K152614 (Cepheid, 2016) after a 91-day review. Its family tree reaches back 4 generations to 1997.

Decided: May 10, 2019
Review: 91 days
Class: Class II
Product code: PMY
Recalls: None
Predicates: 1

Its longest line of descent runs back 4 generations to K972359 (1997). No later device cites it as a predicate yet.

By dateBy generation

Root · 4 generations backK972359 Remel Bile Esculin Azide Agar W/6 MCG/ML VancomycinRemel, L.P. · 1997 · Recalled
3 generations backK061686 Idi-Vanr AssayGeneohm Sciences Canada, Inc. · 2006
2 generations backK092953 Xpert VanA AssayCepheid · 2009
1 generation backK152614 Xpert Carba-RCepheid · 2016
This deviceK190275 GenePOC CarbaGenepoc, Inc. · 2019

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K972359	Remel Bile Esculin Azide Agar W/6 MCG/ML Vancomycin	Remel, L.P.	1997	1
−3	K061686	Idi-Vanr Assay	Geneohm Sciences Canada, Inc.	2006	—
−2	K092953	Xpert VanA Assay	Cepheid	2009	—
−1	K152614	Xpert Carba-R	Cepheid	2016	—
0 (this device)	K190275	GenePOC Carba	Genepoc, Inc.	2019	—

FIG. 1 — Lineage of K190275, 1997–2019Source: 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 PMY? 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 PMY device

#1 K191288 Acuitas AMR Gene Panelscore 3.0 · 4 generations · no Class I recall

Get a 510(k) 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	Applicant	Decided	Recalls
*	K152614	Xpert Carba-R Summary page 7 …report that can be viewed and printed. K. SUBSTANTIAL EQUIVALENCE INFORMATION 1. Predicate Device Name: Xpert® Carba-R Assay 2. Predicate 510(k) Number: K152614 3. Comparison with Predicate: The GenePOC™ Carba assay is substantially equivalent to the Xpert® Carba-R Assay (K152…	Cepheid	2016	—

Also cleared against K152614: 2 other devices →

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 22 years and passes through 4 companies; a new generation was cleared every 6.2 years on median.
1 of the 4 ancestors has a recall of any class.
2 other devices also cite its predicate K152614.

How does its category compare?

All PMY devices

PMY System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.

FDA decisions per year · PMY

1in 2021

2007high 1 (2016) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PMY

Too few PMY 510(k)s in any year since 2007 to give a median.

Recalls per year · PMY

No recall names PMY since 2007.

Adverse event reports per year · PMY

No MAUDE report names PMY 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	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	1	—	0
2017	0	—	0
2018	0	—	0
2019	1	—	0
2020	0	—	0
2021	1	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

The GenePOC™ Carba assay, performed on the revogene™ instrument, is a qualitative in vitro diagnostic test designed for the detection and differentiation of the blaKPC, blaNDM, blaVIM, blaOXA-48-like, and blaIMP gene sequences associated with carbapenem-non-susceptible pure colonies of Enterobacteriaceae, Acinetobacter baumannii, or Pseudomonas aeruginosa, when grown on blood agar or MacConkey agar. The test utilizes automated real-time Polymerase Chain…

Read the full statement (162 words)

The GenePOC™ Carba assay should be used in conjunction with other laboratory tests including phenotypic antimicrobial susceptibility testing. A negative GenePOC™ Carba assay result does not preclude the presence of other resistance mechanisms.

The GenePOC™ Carba assay is intended as an aid for infection control in the detection of carbapenem-non-susceptible bacteria that colonize patients in healthcare settings. The identification of a blaIMP, blaNDM or blaVIM metallo-β-lactamase gene (i.e., the genes that encode the IMP, NDM and VIM metallo-β-lactamases, respectively) may be used as an aid to clinicians in determining appropriate therapeutic strategies for patients with known or suspected carbapenem non-susceptible infections.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K190275 · printed Nov 5, 2026

Cite this page

510(k) Report. “K190275: GenePOC Carba.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K190275

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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