Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System

K221160 · Cepheid · PQA · Jun 7, 2022 · Microbiology

Device Facts

• Record ID: K221160
• Device Name: Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System
• Applicant: Cepheid
• Product Code: PQA · Microbiology
• Decision Date: Jun 7, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.3975
• Device Class: Class 2

Indications for Use

The Xpert® Xpress MVP test, performed on the GeneXpert® Instrument Systems, is an automated qualitative in vitro diagnostic test for the detection of DNA targets from anaerobic bacteria associated with bacterial vaginosis (BV). Candida species associated with vulvovaginal candidiasis, and Trichomonas vaginalis. The Xpert Xpress MVP test uses clinician-collected and self-collected vaginal swabs (collected in a clinical setting) from patients who are symptomatic for vaginitis/vaginosis. The Xpert Xpress MVP test utilizes real-time polymerase chain reaction (PCR) for the amplification of specific DNA targets and utilizes fluorogenic target-specific hybridization probes to detect and differentiate DNA from: . Organisms associated with bacterial vaginosis (detected organisms not reported individually) o Atopobium spp. (Atopobium vaginae, Atopobium novel species CCUG 55226) Bacterial Vaginosis-Associated Bacterium 2 (BVAB2) O o Megasphaera-1 . Candida spp. (C. albicans, C. tropicalis, C. parapsilosis, C. dubliniensis, species not differentiated) Candida glabrata/Candida krusei (species not differentiated) . Trichomonas vaginalis The Xpert Xpress MVP test is intended to aid in the diagnosis of vaginal infections in women with a clinical presentation consistent with bacterial vaginosis, vulvovaginal candidiasis, or trichomoniasis.

Device Story

Xpert Xpress MVP is a multiplex nucleic acid amplification test for microorganisms associated with vaginitis and bacterial vaginosis. Operates on GeneXpert Dx and GeneXpert Infinity systems. Input: clinical samples; processing: automated nucleic acid extraction, amplification, and real-time detection via cartridge-based reagents; output: qualitative detection of target microorganisms. Used in clinical laboratory settings by trained personnel. Results assist clinicians in diagnosing vaginitis/bacterial vaginosis. Modification (K221160) involves cartridge reagent changes to extend shelf life and updated Assay Definition File commands.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by design control activities, risk analysis, and verification/validation of reagent and software modifications.

Technological Characteristics

Real-time PCR assay; automated nucleic acid extraction/amplification. Disposable, single-use, multi-chambered fluidic cartridge. GeneXpert Instrument System (instrument, computer, preloaded software). Qualitative detection of DNA targets. Assay includes Sample Processing Control (SPC) and Probe Check Control (PCC).

Indications for Use

Indicated for symptomatic women (≥14 years) presenting with signs/symptoms of vaginitis/vaginosis (e.g., abnormal discharge, dysuria, itching, burning, irritation, pain, edema, or odor) to aid in the diagnosis of bacterial vaginosis, vulvovaginal candidiasis, or trichomoniasis using clinician-collected or self-collected vaginal swabs.

Regulatory Classification

Identification

A device that detects nucleic acid sequences from microorganisms associated with vaginitis and bacterial vaginosis is a qualitative in vitro diagnostic device intended for the detection of microbial nucleic acid sequences in vaginal specimens collected from patients with signs and symptoms of vaginitis or bacterial vaginosis. This device is intended to aid in the diagnosis of vaginitis or bacterial vaginosis when used in conjunction with clinical signs and symptoms and other laboratory findings.

Special Controls

*Classification.* Class II (special controls). The special controls for this device are:(1) Design verification and validation must include: (i) Documentation with a detailed device description of device components; ancillary reagents required but not provided; and explanation of the methodology including primer/probe sequence, design, and rationale for sequence selection. (ii) Documentation with information that demonstrates the performance characteristics of the device, including: (A) Limit of Detection; (B) Precision (reproductivity); (C) Analytical specificity; (D) Analytical reactivity (inclusivity); (E) Specimen stability; and (F) Effects of interfering substances. (iii) Detailed documentation from a prospective clinical study. As appropriate to the intended use, the prospective clinical study must be performed on an appropriate study population, including women of various ages and ethnicities. The prospective clinical study must compare the device performance to results obtained from well-accepted comparator methods. (iv) Detailed documentation for device software, including software applications and hardware-based devices that incorporate software. (2) The labeling required under § 809.10(b) of this chapter must include: (i) A detailed explanation of the interpretation of results and acceptance criteria; (ii) For devices with an intended use that includes detection of nucleic acid sequences from bacteria associated with bacterial vaginosis, clinical performance stratified by patient demographics such as race, ethnicity, age, and pregnancy status. (iii) For devices with an intended use that includes detection of nucleic acid sequences from bacteria associated with bacterial vaginosis, a summary of device results in an asymptomatic population with demographic characteristics appropriate to the intended use population. (iv) For devices with an intended use that includes detection of either Candida species or bacteria associated with bacterial vaginosis, a limitation that *Candida* species and bacterial compositions associated with bacterial vaginosis can be present as part of normal vaginal flora and results should be considered in conjunction with available clinical information.

Predicate Devices

• Xpert Xpress MVP (K212536)

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

K221160

B Applicant

Cepheid

C Proprietary and Established Names

Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| PQA | Class II | 21 CFR 866.3975 - Device That Detects Nucleic Acid Sequences From Microorganisms Associated With Vaginitis And Bacterial Vaginosis | 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 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 NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available,

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).

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 modifications include changes to cartridge reagents to increase shelf life and changes to Assay Definition File commands to accommodate reagent changes.

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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