Xpert Carba-R

K261867 · Cepheid® · POC · Jul 2, 2026 · Microbiology

Device Facts

• Record ID: K261867
• Device Name: Xpert Carba-R
• Applicant: Cepheid®
• Product Code: POC · Microbiology
• Decision Date: Jul 2, 2026
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.1640
• Device Class: Class 2

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.

Device Story

Xpert Carba-R is a qualitative in vitro diagnostic test for detecting carbapenemase gene sequences; utilizes rectal swab specimens; processed on GeneXpert Instrument Systems. Device identifies genetic markers associated with carbapenem-non-susceptible Enterobacterales, Acinetobacter baumannii, and Pseudomonas aeruginosa. Used for surveillance and epidemiological tracking; not for clinical treatment decisions. Healthcare providers use results to monitor colonization status. Modification includes updated taxonomic nomenclature (Enterobacterales) and revised inclusivity analysis/wet-testing data for carbapenemase subtypes.

Clinical Evidence

No clinical trial data presented. Evidence consists of in silico analysis of current variant sequence data (NCBI database 2026) to verify primer/probe coverage, supplemented by inclusivity bench testing for selected variants.

Technological Characteristics

In vitro diagnostic test for GeneXpert Instrument Systems. Uses nucleic acid amplification technology for detection of carbapenemase gene sequences. Software-based analysis of amplification data.

Indications for Use

Indicated for patients at risk for intestinal colonization with carbapenem-non-susceptible bacteria. Used with rectal swab specimens to aid in surveillance and epidemiological tracking of carbapenem-non-susceptible Enterobacterales, Acinetobacter baumannii, and Pseudomonas aeruginosa.

Regulatory Classification

Identification

An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.

Predicate Devices

• Xpert Carba-R (K173263)

Submission Summary (Full Text)

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FDA

U.S. FOOD & DRUG

ADMINISTRATION

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY

# I Background Information:

A 510(k) Number

K261867

B Applicant

Cepheid

C Proprietary and Established Names

Xpert Carba-R

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| POC, PMY | Class II | 21 CFR 866.1640 Antimicrobial susceptibility test powder | Microbiology |
| OOI | Class II | 21 CFR 862.2570 Instrumentation for clinical multiplex test systems | Clinical Chemistry |

# II Review Summary:

This 510(k) submission contains information/data on modifications made to the submitter's own CLASS II device requiring 510(k). The following items are present and acceptable.

1. The name and 510(k) number of the SUBMITTER'S previously cleared device.
2. Submitter's statement that the INDICATIONS FOR USE/INTENDED USE of the modified device as described in its labeling HAS CHANGED along with the proposed labeling which includes instructions for use and package insert. The labeling changes are considered minor and do not affect the intended use of the original or modified device.

The changes in the Intended Use/Indications for Use statement of the modified device (K261867) aim to:

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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a) Replace the term “Assay” with “test” throughout the Intended Use to maintain consistency across all Cepheid products, since “Assay” (or “test”) is not meant to be part of the device name.

b) Update the terminology from "Enterobacteriaceae" to "Enterobacterales" to reflect current taxonomic nomenclature.

3. A description of the device **MODIFICATION(S)**, including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the **FUNDAMENTAL SCIENTIFIC TECHNOLOGY** of the modified device **has not changed**.

The **changes** in the labeling of the modified device (K261867) aim to:

a) Update labeling to reflect the most recent *in silico* inclusivity analysis and wet-testing, including reclassification of select carbapenemase subtypes and addition of newly identified subtypes.

b) Revise the limitations to reflect outcomes from the updated *in silico* inclusivity analysis and supplemental wet-testing.

4. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis methods used to assess the impact of the modification on the device and its components, and the results of the analysis.

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modifications and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared device.

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