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 Jan 9, 2018 as substantially equivalent to K160901 (Cepheid, 2016) after a 90-day review. Its family tree reaches back 5 generations to 1997. 1 later device descends from it.
- Decided
- Jan 9, 2018
- Review
- 90 days
- Class
- Class II
- Product code
- POC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K972359 (1997). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK972359 Remel Bile Esculin Azide Agar W/6 MCG/ML VancomycinRemel, L.P. · 1997 · Recalled
- 4 generations backK061686 Idi-Vanr AssayGeneohm Sciences Canada, Inc. · 2006
- 3 generations backK092953 Xpert VanA AssayCepheid · 2009
- 2 generations backK152614 Xpert Carba-RCepheid · 2016
- 1 generation backK160901 Xpert Carba-RCepheid · 2016
- This deviceK173263 Xpert Carba-RCepheid · 2018
- Descendant · cites it directly · 0 of its ownK261867 Xpert Carba-RCepheid® · 2026
Most influential descendants
Showing 1 of 1 · See all- K261867Xpert Carba-RCepheid® · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K972359 | Remel Bile Esculin Azide Agar W/6 MCG/ML Vancomycin | Remel, L.P. | 1997 | 1 |
| −4 | K061686 | Idi-Vanr Assay | Geneohm Sciences Canada, Inc. | 2006 | — |
| −3 | K092953 | Xpert VanA Assay | Cepheid | 2009 | — |
| −2 | K152614 | Xpert Carba-R | Cepheid | 2016 | — |
| −1 | K160901 | Xpert Carba-R | Cepheid | 2016 | — |
| 0 (this device) | K173263 | Xpert Carba-R | Cepheid | 2018 | — |
| +1 | K261867 | Xpert Carba-R | Cepheid® | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 POC? 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 POC device
- #1 K261867 Xpert Carba-Rscore 13.1 · 6 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 |
|---|---|---|---|
| * | K160901 | Xpert Carba-RSummary page 4…Microbiology (83) Advisory Panel Prescription Use Yes Predicate Device Cepheid Xpert ® Carba-R Assay: [510(k) #K160901] Xpert Carba-R Assay 510(k) Page 8-1… | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K261867 | Xpert Carba-R | 2026 | 0 |
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 21 years and passes through 3 companies; a new generation was cleared every 3.3 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K261867 (Cepheid®, 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K160901.
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. 2018, 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 Assay, 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 Assay is intended as an aid to infection control in the detection of…
Read the full statement (262 words)
The Xpert® Carba-R Assay, 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 Assay 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 Assay result does not preclude the presence of other resistance mechanisms.
The Xpert Carba R-Assay is for use with the following sample types:
Pure Colonies
The assay is performed on carbapenem-non-susceptible pure colonies of Enterobacteriaceae, Acinetobacter baumannii, or Pseudomonas aeruginosa, when grown on blood agar or MacConkey agar. For testing pure colonies, the Xpert Carba-R Assay 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 assay 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 Assay, 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 as stated in the FDA summary.
https://510kreport.com/device/K173263 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173263: 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/K173263
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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