510(k) · Cleared
ClearedXpert Carba-R
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cepheid · PMY System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony
Cleared on Mar 7, 2016 as substantially equivalent to K092953 (Cepheid, 2009) after a 175-day review. Its family tree reaches back 3 generations to 1997. 6 later devices descend from it.
- Decided
- Mar 7, 2016
- Review
- 175 days
- Class
- Class II
- Product code
- PMY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K972359 (1997). 6 later devices descend from it, 3 citing it directly.
- 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 deviceK152614 Xpert Carba-RCepheid · 2016
- Descendant · cites it directly · 3 of its ownK160901 Xpert Carba-RCepheid · 2016
- Descendant · 2 generations on · 1 of its ownK173263 Xpert Carba-RCepheid · 2018
- Descendant · 3 generations on · 0 of its ownK261867 Xpert Carba-RCepheid® · 2026
- Descendant · cites it directly · 0 of its ownK191288 Acuitas AMR Gene PanelOpgen, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK190613 BD MAX Check-Points CPOCheck-Points Health B.V. · 2019
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K160901Xpert Carba-RCepheid · 2016 · cites it directly3descendants
- K173263Xpert Carba-RCepheid · 2018 · 2 generations on1descendant
- K261867Xpert Carba-RCepheid® · 2026 · 3 generations on0descendants
- K191288Acuitas AMR Gene PanelOpgen, Inc. · 2021 · cites it directly0descendants
- K190613BD MAX Check-Points CPOCheck-Points Health B.V. · 2019 · 2 generations on0descendants
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) | K152614 | Xpert Carba-R | Cepheid | 2016 | — |
| +1 | K160901 | Xpert Carba-R | Cepheid | 2016 | — |
| +2 | K173263 | Xpert Carba-R | Cepheid | 2018 | — |
| +3 | K261867 | Xpert Carba-R | Cepheid® | 2026 | — |
| +1 | K191288 | Acuitas AMR Gene Panel | Opgen, Inc. | 2021 | — |
| +2 | K190613 | BD MAX Check-Points CPO | Check-Points Health B.V. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 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 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
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 |
|---|---|---|---|
| * | K092953 | Xpert VanA AssaySummary page 4…lassification Microbiology (83) Advisory Panel Prescription Use Yes Predicate Device Cepheid Xpert ® vanA Assay: [510(k) #K092953] Page 1 Device Description: The Xpert Carba-R Assay is an automated… | 2009 |
What descends from it? (6)
3 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 19 years and passes through 3 companies; a new generation was cleared every 6.2 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K160901 (Cepheid, 2016) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K092953.
How does its category compare?
All PMY devicesPMY 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. 2016, this device’s year, is highlighted.
FDA decisions per year · PMY
1in 2021
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 | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Xpert® Carba-R Assay, performed on the GeneXpert® Instrument Systems, is a qualitative in vitro diagnostic test for the detection and differentiation of the blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP gene sequences associated with carbapenem-non-susceptible pure colonies of Enterobacteriaceae, Acinetobacter baumannii, or Pseudomonas aeruginosa grown on blood agar or MacConkey agar. The test utilizes automated real-time polymerase chain reaction…
Read the full statement (139 words)
The Xpert® Carba-R Assay, performed on the GeneXpert® Instrument Systems, is a qualitative in vitro diagnostic test for the detection and differentiation of the blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP gene sequences associated with carbapenem-non-susceptible pure colonies of Enterobacteriaceae, Acinetobacter baumannii, or Pseudomonas aeruginosa grown on blood agar or MacConkey agar. The test utilizes automated real-time polymerase chain reaction (PCR).
A negative Xpert Carba-R Assay result does not preclude the presence of other resistance mechanisms. The Xpert Carba-R Assay should be used in conjunction with other laboratory tests including phenotypic antimicrobial susceptibility testing. The Xpert Carba-R Assay is intended as an aid for infection control in detecting and differentiating genetic markers of resistance to monitor the spread of carbapenem-non-susceptible organisms in healthcare settings. The Xpert Carba-R Assay is not intended to guide or monitor treatment for carbapenem-non-susceptible bacterial infections.
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/K152614 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152614: Xpert Carba-R.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152614
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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