# K261867: Xpert Carba-R

- Pathway: 510(k) (Special)
- Applicant: Cepheid®
- Decided: Jul 2, 2026 after 28 days
- Product code: POC (System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen)
- Device class: 2
- Regulation: 21 CFR 866.1640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K972359 (1997). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173263: Xpert Carba-R, Cepheid (2018) Summary page 8.

## Indications for use
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.

Source page: https://510kreport.com/device/K261867
Methodology: https://510kreport.com/methodology