Xpert vanA

K243405 · Cepheid® · NIJ · Nov 21, 2024 · Microbiology

Device Facts

• Record ID: K243405
• Device Name: Xpert vanA
• Applicant: Cepheid®
• Product Code: NIJ · Microbiology
• Decision Date: Nov 21, 2024
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.1640
• Device Class: Class 2

Indications for Use

The Xpert® vanA test performed on the GeneXpert® Instrument Systems is a qualitative in vitro diagnostic test designed for detection of the vanA gene sequence associated with vancomycin resistance in bacteria obtained from rectal swab specimens from patients at risk for intestinal colonization with vancomycin-resistant bacteria. The test utilizes automated real-time polymerase chain reaction (PCR) to detect the vanA gene that is frequently associated with vancomycin-resistant enterococci (VRE). The Xpert vanA test is intended to aid in the recognition, prevention, and control of vancomycin-resistant organisms that colonize patients in healthcare settings. The Xpert vanA test is not intended to diagnose infections caused by vancomycin-resistant bacteria nor to guide or monitor treatment for vancomycin-resistant bacterial infections. Concomitant cultures are necessary to recover organisms for identification of vancomycin-resistant bacteria, antimicrobial susceptibility testing, and for epidemiological typing.

Device Story

Xpert vanA is an in vitro diagnostic test for detecting vanA gene in rectal swab specimens; utilizes GeneXpert Instrument Systems for automated processing; identifies vancomycin-resistant Enterococcus faecium (VRE). Modification includes expanding instrument compatibility to include GeneXpert Infinity System; updates nomenclature from 'assay' to 'test'; removes 'rapid' descriptor. Operates via nucleic acid amplification; provides qualitative results to clinicians for infection control and patient management. Used in clinical laboratory settings; performed by trained laboratory personnel.

Clinical Evidence

No clinical data provided; substantial equivalence established via design control activities, risk analysis, and verification of fundamental scientific technology consistency with the predicate device.

Technological Characteristics

Nucleic acid amplification test (NAAT) using real-time PCR. Components: single-use disposable fluidic cartridge, GeneXpert instrument (syringe drive, ultrasonic horn, I-CORE thermocycler). Internal controls: Sample Processing Control (SPC) and Probe Check Control (PCC). Connectivity: Windows OS-based PC with GeneXpert Dx, Cepheid OS, or Xpertise software. Sterilization: N/A (disposable cartridge).

Indications for Use

Indicated for qualitative detection of vanA gene in vancomycin-resistant Enterococcus faecium (VRE) from rectal swab specimens using GeneXpert Instrument Systems.

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 vanA Assay (K092953)

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

K243405

B Applicant

Cepheid

C Proprietary and Established Names

Xpert vanA

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| NIJ | Class II | 21 CFR 866.1640 – Antimicrobial Susceptibility Test Powder | MI – Microbiology |
| OOI | Class II | 21 CFR 862.2570 – Instrumentation for clinical multiplex test systems | CH – Clinical Chemistry |

## II Review Summary:

This 510(k) submission contains information/data on modifications made to the submitter's (Cepheid) own CLASS II device requiring a 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 inserts. These 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 (K243405) aim to:

(a) Incorporate the “GeneXpert Instrument Systems” family of instruments—in order to accommodate a new member (the GeneXpert Infinity System) of this family—while retaining other instruments in the same family, that were previously cleared with the predicate (K092953).
(b) Remove the term "rapid" to better align with the assay's time-to-result.

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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(c) Change the modified device name from "Cepheid Xpert vanA Assay" to "Xpert vanA" in the Intended Use/Indications for Use opening statement.

(d) Describe the modified device as a "test" (which incorporates assay and instrument) instead of as an "assay" as was previously done.

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

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 method(s) 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 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 for use/intended use for the device (i.e., detection of vanA) is unaffected by the modification. In addition, the submitter's description of the particular modification(s) 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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