510(k) · Cleared
ClearedXpert Carba-R
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cepheid® · POC System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen
Cleared on Jul 2, 2026 as substantially equivalent to K173263 (Cepheid, 2018) after a 28-day review. Its family tree reaches back 6 generations to 1997.
- Decided
- Jul 2, 2026
- Review
- 28 days
- Class
- Class II
- Product code
- POC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K972359 (1997). No later device cites it as a predicate yet.
- Root · 6 generations backK972359 Remel Bile Esculin Azide Agar W/6 MCG/ML VancomycinRemel, L.P. · 1997 · Recalled
- 5 generations backK061686 Idi-Vanr AssayGeneohm Sciences Canada, Inc. · 2006
- 4 generations backK092953 Xpert VanA AssayCepheid · 2009
- 3 generations backK152614 Xpert Carba-RCepheid · 2016
- 2 generations backK160901 Xpert Carba-RCepheid · 2016
- 1 generation backK173263 Xpert Carba-RCepheid · 2018
- This deviceK261867 Xpert Carba-RCepheid® · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K972359 | Remel Bile Esculin Azide Agar W/6 MCG/ML Vancomycin | Remel, L.P. | 1997 | 1 |
| −5 | K061686 | Idi-Vanr Assay | Geneohm Sciences Canada, Inc. | 2006 | — |
| −4 | K092953 | Xpert VanA Assay | Cepheid | 2009 | — |
| −3 | K152614 | Xpert Carba-R | Cepheid | 2016 | — |
| −2 | K160901 | Xpert Carba-R | Cepheid | 2016 | — |
| −1 | K173263 | Xpert Carba-R | Cepheid | 2018 | — |
| 0 (this device) | K261867 | Xpert Carba-R | Cepheid® | 2026 | — |
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 POC? 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
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 |
|---|---|---|---|
| * | K173263 | Xpert Carba-RSummary page 8…System, OOI Classification Microbiology (83) Advisory Panel Prescription Use Yes Predicate Device Xpert® Carba-R (K173263) Assay: 510(k) Summary Page 3 of 9 X… | 2018 |
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 29 years and passes through 4 companies; a new generation was cleared every 6.2 years on median.
- 1 of the 6 ancestors has a recall of any class.
How does its category compare?
All POC devicesPOC System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · POC
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · POC
Too few POC 510(k)s in any year since 2007 to give a median.
Recalls per year · POC
No recall names POC since 2007.
Adverse event reports per year · POC
1in 2025
MAUDE reports naming product code POC, not matched to any one device; reports are not rates.
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 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Xpert Carba-R test, performed on the GeneXpert Instrument Systems, is a qualitative in vitro diagnostic test designed for the detection and differentiation of the blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP gene sequences associated with carbapenem-non-susceptibility. The test utilizes automated real-time polymerase chain reaction (PCR). The Xpert Carba-R test is intended as an aid to infection control in the detection of carbapenem-non-susceptible…
Read the full statement (262 words)
The Xpert Carba-R test, performed on the GeneXpert Instrument Systems, is a qualitative in vitro diagnostic test designed
for the detection and differentiation of the blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP gene sequences
associated with carbapenem-non-susceptibility. The test utilizes automated real-time polymerase chain reaction (PCR).
The Xpert Carba-R test is intended as an aid to infection control in the detection of carbapenem-non-susceptible bacteria
that colonize patients in healthcare settings. A negative Xpert Carba-R test result does not preclude the presence of other
resistance mechanisms.
The Xpert Carba-R test is for use with the following sample types:
Pure Colonies
The test is performed on carbapenem-non-susceptible pure colonies of Enterobacterales, Acinetobacter baumannii, or
Pseudomonas aeruginosa, when grown on blood agar or MacConkey agar. For testing pure colonies, the Xpert Carba-R
test should be used in conjunction with other laboratory tests including phenotypic antimicrobial susceptibility testing.
The identification of a blaIMP, blaNDM, or blaVIM metallo-beta-lactamase gene (i.e., the genes that encode the IMP,
NDM, and VIM metallo-beta-lactamases, respectively) may be used as an aid to clinicians in determining appropriate
therapeutic strategies for patients with known or suspected carbapenem-non-susceptible bacterial infections.
Rectal and Perirectal Swab Specimens
The test is performed on rectal and perirectal swab specimens from patients at risk for intestinal colonization with
carbapenem-non-susceptible bacteria. Concomitant cultures are necessary to recover organisms for epidemiological
typing, antimicrobial susceptibility testing, and for further confirmatory bacterial identification.
The Xpert Carba-R test, when performed on rectal and perirectal swab specimens, is not intended to guide or monitor
treatment for carbapenem-non-susceptible bacterial infections or to determine infection from carbapenem-non-susceptible
bacteria.
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/K261867 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261867: 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/K261867
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026