Xpert® SA Nasal Complete

K243070 · Cepheid® · NQX · Oct 25, 2024 · Microbiology

Device Facts

• Record ID: K243070
• Device Name: Xpert® SA Nasal Complete
• Applicant: Cepheid®
• Product Code: NQX · Microbiology
• Decision Date: Oct 25, 2024
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.1640
• Device Class: Class 2

Indications for Use

The Xpert® SA Nasal Complete test performed on the GeneXpert® Instrument Systems is a qualitative in vitro diagnostic test designed for detection of Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) from nasal swabs in patients at risk for nasal colonization. The test utilizes automated real-time polymerase chain reaction (PCR) to detect MRSA/SA DNA. The Xpert® SA Nasal Complete test is intended to aid in the prevention and control of MRSA/SA infections in healthcare settings. The Xpert® SA Nasal Complete test is not intended to diagnose, guide or monitor treatment for MRSA/SA infections, or provide results of susceptibility to methicillin. A negative result does not preclude MRSA/SA nasal colonization. Concomitant cultures are necessary to recover organisms for epidemiological typing or for further susceptibility testing.

Device Story

Xpert SA Nasal Complete is an in vitro diagnostic test for detecting Staphylococcus aureus DNA in nasal specimens. It utilizes the GeneXpert Instrument Systems, including GeneXpert Infinity Systems, to process samples. The device functions as a molecular assay, identifying specific genetic markers to aid healthcare providers in infection control and prevention. It is intended for use in clinical laboratory settings by trained personnel. The output provides qualitative results regarding the presence of S. aureus, assisting clinicians in implementing appropriate infection control measures for patients.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design control activities, risk analysis, and verification/validation of the modified device's compatibility with the GeneXpert Instrument Systems.

Technological Characteristics

Nucleic acid amplification test (real-time PCR) using disposable, multi-chambered fluidic cartridges. Targets: spa, mecA, and SCCmec genes. Features internal Sample Processing Control (SPC) and Probe Check Control (PCC). Instrument systems include ultrasonic lysis, syringe-driven fluidics, and I-CORE thermocycler. Software runs on Windows OS-based PC. Prescription use only.

Indications for Use

Indicated for the qualitative detection of Staphylococcus aureus DNA in nasal specimens using GeneXpert Instrument Systems to aid in the prevention and control of S. aureus infections in healthcare settings.

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 SA Nasal Complete (K100822)

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

K243070

B Applicant

Cepheid

C Proprietary and Established Names

Xpert SA Nasal Complete

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| NQX | 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 INTENDED USE/INDICATIONS FOR USE of the modified device as described in its labeling HAS CHANGED along with the proposed labeling which includes instructions for use and package labeling. 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 (K243070) aim to:

(a) Incorporate the “GeneXpert Instrument Systems” family of instruments, in order to accommodate a new member (the GeneXpert Infinity Systems) of this family that also encompasses the instruments that were originally cleared with the predicate (K100822).
(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 device name from "Cepheid Xpert SA Nasal Complete Assay" to "Xpert SA Nasal Complete" in the Intended Use/Indications for Use 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/or 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 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 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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