(20 days)
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.
The Xpert van4 test is an automated in vitro diagnostic test for the qualitative detection of the vanA gene sequence associated with vancomycin resistance in bacteria obtained directly from rectal swab specimens. The specimen is collected on a double swab, one of which is placed in a tube containing sample reagent. Following brief vortexing, the content of the sample reagent is transferred to the uniquely labeled Sample Chamber of a disposable fluidic cartridge (the Xpert vanA cartridge). The user initiates a test from the user interface of the GeneXpert® instrument system platform and places the cartridge with sample into the GeneXpert® instrument system which performs hands-off real-time, multiplex polymerase chain reaction (PCR) for the detection of vanA DNA.
In the GeneXpert® Instrument Systems (comprised of the GeneXpert® Dx System, GeneXpert® System with Touchscreen, and GeneXpert® Infinity System), sample preparation, amplification, and real-time detection are all fully automated and completely integrated. The platform requires the use of single-use disposable cartridges that hold the PCR reagents and host the PCR process. Because the cartridges are self-contained, cross-contamination between samples is minimized.
Depending on the specific instrument, a GeneXpert® instrument system may contain 1-80 modules, each of which are randomly accessible and capable of performing separate sample preparation and real-time PCR tests. Each module contains a syringe drive for dispensing fluids (i.e., the syringe drive activates the plunger that works in concert with the rotary valve in the cartridge to move fluids between chambers), an ultrasonic horn for lysing cells or spores, and a proprietary I-CORE thermocycler for performing real-time PCR and detection.
The Xpert van4 test includes reagents for the detection of the gene for vancomycin resistance (van4) as well as an internal sample processing control (SPC) to control for adequate processing of the target bacteria and to monitor the presence of inhibitor(s) in the PCR assay. The SPC also ensures that the PCR conditions (temperature and time) are appropriate for the amplification reaction and that the PCR reagents are functional. The Probe Check Control (PCC) verifies reagent rehydration, PCR tube filling in the cartridge, probe integrity, and dye stability.
The Xpert van 4 test performed on the GeneXpert® Instrument Systems provides results in less than 45 minutes.
Each instrument in the GeneXpert® instrument family is equipped with a Windows OS-based personal computer that is preloaded with software applications for running the tests and viewing the results, as described in Table 1.
The provided text describes a 510(k) premarket notification for the Cepheid Xpert vanA test. This submission is for a modification to an already cleared device (Xpert vanA, K092953) to include the GeneXpert Infinity System instruments. As such, the document primarily focuses on demonstrating that the performance of the modified device is equivalent to the predicate device and does not present a full de novo study with a comprehensive set of acceptance criteria and performance statistics like sensitivity and specificity against a clinical ground truth.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal acceptance criteria with numerical targets for the verification studies. Instead, it describes "verification studies" aiming to show equivalence to the predicate device. The performance is reported qualitatively as "100% agreement of reportable results" and "no statistically significant differences in Ct values."
| Acceptance Criteria (Implied) | Reported Device Performance (Xpert vanA on GeneXpert Infinity System) |
|---|---|
| Cartridge hold time: Maximum acceptable duration between sample addition and test initiation | Verified as 4 hours |
| Functional testing: Agreement of reportable results between predicate and modified device for contrived positive and negative samples | 100% agreement of reportable results |
| Functional testing: No statistically significant difference in Ct values between predicate and modified device for contrived positive samples | No statistically significant differences in Ct values observed between assay runs |
| Overall performance: Equivalent to predicate device (Xpert vanA, K092953) | Demonstrated equivalent performance |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "both contrived positive (vancomycin-resistant (vanA) Enterococcus faecalis cells added to negative matrix) and negative matrix only) samples" for functional testing. However, it does not specify the sample size for these contrived samples.
The data provenance is from verification studies conducted by the manufacturer (Cepheid) to demonstrate the performance of the Xpert vanA test on the GeneXpert Infinity System instruments. The samples are contrived, meaning they were prepared in a laboratory setting, rather than derived from a patient population (i.e., not prospective or retrospective clinical data in the traditional sense).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Given that the test set consisted of "contrived positive" and "negative matrix only" samples, the ground truth was established by the known composition of these laboratory-prepared samples. There is no mention of external experts or clinical adjudication for these ground truths, as the samples were artificially created with a defined vanA status.
4. Adjudication Method for the Test Set
No explicit adjudication method is mentioned. For contrived samples with a known composition, formal adjudication by a panel of experts is typically not performed or necessary. The "ground truth" is inherent in the preparation of the samples.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
This question is not applicable to this submission. The Xpert vanA test is a qualitative in vitro diagnostic test that uses automated real-time PCR to detect the vanA gene sequence. It is a fully automated system, and human interpretation of results is minimal (typically reading a "detected" or "not detected" output). There is no "AI" or "human reader" component in the diagnostic process that would warrant an MRMC study or an assessment of human reader improvement with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the performance evaluated here is essentially standalone (algorithm only). The Xpert vanA test is an automated system where sample preparation, amplification, and real-time detection are fully integrated. The "device performance" refers to the automated output of the system.
7. The Type of Ground Truth Used
The ground truth for the verification studies was based on known, contrived samples. For the "contrived positive" samples, the ground truth was the presence of vanA positive Enterococcus faecalis cells. For "negative matrix only" samples, the ground truth was the absence of vanA.
8. The Sample Size for the Training Set
This document does not provide information about a "training set." This submission focuses on verification studies for a modification to a previously cleared device. Diagnostic devices like this typically undergo extensive development and validation, but the details of the initial development (including training sets for algorithms, if any) are not part of this specific 510(k) summary for a modification. The test is based on PCR, not machine learning that would require a distinct "training set."
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned or applicable in the context of this PCR-based diagnostic device and modification, how its ground truth was established is not provided in the document.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of the symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" above the word "ADMINISTRATION". The logo is simple and professional, conveying the organization's role in regulating food and drugs.
November 21, 2024
Cepheid % Riva Dill-Garlow, Ph.D. Regulatory Affairs Senior Specialist 904 Caribbean Drive Sunnyvale, California 94089
Re: K243405
| Trade/Device Name: | Xpert vanA |
|---|---|
| Regulation Number: | 21 CFR §866.1640 |
| Regulation Name: | Antimicrobial Susceptibility Test Powder |
| Regulatory Class: | Class II |
| Product Code: | NIJ, OOI |
| Dated: | October 31, 2024 |
| Received: | November 1, 2024 |
Dear Riva Dill-Garlow:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations (CFR), Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR $820), which includes, but is not limited to, 21 CFR §820.30, Design controls; 21 CFR §820.90, Nonconforming product; and 21 CFR §820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review
{1}------------------------------------------------
and approve changes to device design and production (21 CFR §820.70 and 21 CFR §820.70) and document changes and approvals in the device master record (21 CFR §820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR §801); labeling (21 CFR §801 and $809); medical device reporting of medical device-related adverse events) (21 CFR $803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR §820) for devices or current good manufacturing practices (21 CFR Part 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR §801.20(a)) unless an exception or alternative applies (21 CFR §801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR §801.18. The UDI Rule (21 CFR §830.300(a) and §830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR 8830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR $807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR §803), please go to https://www.fda.gov/medical-device-safety/medical-device-reporting-mdrhow-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ribhi Shawar-S
Ribhi Shawar, Ph.D. (ABMM) Branch Chief General Bacteriology and Antimicrobial Susceptibility Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K243405
Device Name Xpert® van A
Indications for Use (Describe)
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, and control of vancomycinresistant 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.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the Cepheid logo above the text "Xpert vanA". The Cepheid logo is a stylized blue wave above the company name. The text "Xpert" has a registered trademark symbol next to it, and "vanA" is written below it.
510(k) Summary for Xpert vanA
{4}------------------------------------------------
Image /page/4/Picture/1 description: The image contains the logo for Cepheid, a molecular diagnostics company. The logo features a stylized blue wing-like graphic above the company name, "Cepheid." Below the company name is the text "Xpert® vanA", which likely refers to one of Cepheid's diagnostic tests, Xpert vanA, which is used to detect vancomycin-resistant enterococci.
TABLE OF CONTENTS
| 510(K) SUMMARY | ||
|---|---|---|
| 1.1 | DEVICE DESCRIPTION | |
| 1.2 | DEVICE INTENDED USE…………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………… | |
| 1.3 | TECHNICAL CHARACTERISTICS | |
| 1.4 | SUBSTANTIAL EQUIVALENCE | |
| 1.5 | SUMMARY OF PERFORMANCE DATA | |
| 1.6 | CONCLUSION |
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the Cepheid logo with the text "Cepheid." in a stylized font. Below the logo, the text "Xpert® vanA" is displayed, with the "®" symbol indicating a registered trademark. The text is aligned to the left and is in a smaller font size compared to the logo.
1 510(k) Summary
As required by 21 CFR Section 807.92.
| Submitted by: | Cepheid904 Caribbean DriveSunnyvale, CA 90489Phone number: (408) 541-4191 |
|---|---|
| Contact: | Riva Dill-Garlow, PhD |
| Date of Preparation: | October 31, 2024 |
| Device: | |
| Trade name | Xpert® vanA |
| Common name | Xpert vanA test |
| Type of Test | Qualitative nucleic acid amplification test of the vanA genedirectly from rectal swabs |
| Regulation number: | 21 CFR §866.1640 |
| Classification name: | Antimicrobial susceptibility test powder |
| Product code: | NIJ, OOI |
| ClassificationAdvisory Panel | Microbiology (83) |
| Prescription Use | Yes |
| Predicate Device | Xpert vanA Assay (K092953) |
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the Cepheid logo above the text "Xpert® vanA". The Cepheid logo consists of a stylized wing-like design above the company name. The text "Xpert® vanA" is written in a simple, sans-serif font, with the "®" symbol indicating a registered trademark.
1.1 Device Description
The Xpert van4 test is an automated in vitro diagnostic test for the qualitative detection of the vanA gene sequence associated with vancomycin resistance in bacteria obtained directly from rectal swab specimens. The specimen is collected on a double swab, one of which is placed in a tube containing sample reagent. Following brief vortexing, the content of the sample reagent is transferred to the uniquely labeled Sample Chamber of a disposable fluidic cartridge (the Xpert vanA cartridge). The user initiates a test from the user interface of the GeneXpert® instrument system platform and places the cartridge with sample into the GeneXpert® instrument system which performs hands-off real-time, multiplex polymerase chain reaction (PCR) for the detection of vanA DNA.
In the GeneXpert® Instrument Systems (comprised of the GeneXpert® Dx System, GeneXpert® System with Touchscreen, and GeneXpert® Infinity System), sample preparation, amplification, and real-time detection are all fully automated and completely integrated. The platform requires the use of single-use disposable cartridges that hold the PCR reagents and host the PCR process. Because the cartridges are self-contained, cross-contamination between samples is minimized.
Depending on the specific instrument, a GeneXpert® instrument system may contain 1-80 modules, each of which are randomly accessible and capable of performing separate sample preparation and real-time PCR tests. Each module contains a syringe drive for dispensing fluids (i.e., the syringe drive activates the plunger that works in concert with the rotary valve in the cartridge to move fluids between chambers), an ultrasonic horn for lysing cells or spores, and a proprietary I-CORE thermocycler for performing real-time PCR and detection.
The Xpert van4 test includes reagents for the detection of the gene for vancomycin resistance (van4) as well as an internal sample processing control (SPC) to control for adequate processing of the target bacteria and to monitor the presence of inhibitor(s) in the PCR assay. The SPC also ensures that the PCR conditions (temperature and time) are appropriate for the amplification reaction and that the PCR reagents are functional. The Probe Check Control (PCC) verifies reagent rehydration, PCR tube filling in the cartridge, probe integrity, and dye stability.
The Xpert van 4 test performed on the GeneXpert® Instrument Systems provides results in less than 45 minutes.
Each instrument in the GeneXpert® instrument family is equipped with a Windows OS-based personal computer that is preloaded with software applications for running the tests and viewing the results, as described in Table 1.
{7}------------------------------------------------
Image /page/7/Picture/1 description: The image shows the Cepheid logo above the text "Xpert® vanA". The Cepheid logo is a stylized blue wing-like shape. The text "Cepheid" is in a serif font, and the text "Xpert® vanA" is in a sans-serif font.
| Table 1: Instrument Systems and Software in the GeneXpert® Instrument Family | ||
|---|---|---|
| Members |
| Instrument FamilyMembers | InstrumentSystems | SystemsSoftware | Instruments |
|---|---|---|---|
| GeneXpert®Instrument Systems | GeneXpert® DxSystem | GeneXpert Dx | GX-I† GX-II GX-IV GX-XVI |
| GeneXpert®System withTouchscreen | Cepheid OS | GX-II GX-IV GX-XVI | |
| GeneXpert®Infinity System | GeneXpertXpertise | GeneXpert Infinity-48s GeneXpert Infinity-80 |
ً No longer manufactured but is in circulation in the market
1.2 Device Intended 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 vancomvcin 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 van A 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.
1.3 Technical Characteristics
The Xpert vanA test has the same technological characteristics as the predicate device.
1.4 Substantial Equivalence
The purpose of this Special 510(k) submission is to modify the cleared, legally marketed device (Xpert vanA) to include the GeneXpert® Infinity System instruments (see Table 1 above). The Xpert vanA test was originally cleared for use on the GeneXpert® Dx System (K092953). Both the GeneXpert Dx System and the GeneXpert Infinity System are members of the instrument family "GeneXpert® Instrument Systems" which is now incorporated in the Intended Use/Indications for Use of this device. Table 2 shows the similarities and Table 3 shows the differences between the Xpert vanA test and predicate device. The differences between Xpert van A test and predicate device do not raise different questions of safety and effectiveness.
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image contains the Cepheid logo, which features a stylized blue wing design above the company name in black. Below the logo, the text "Xpert® vanA" is displayed, with "Xpert" in a larger font size and the registered trademark symbol. The text is left-aligned and appears to be part of a product or service name offered by Cepheid.
| Similarities | ||
|---|---|---|
| Attribute | Modified DeviceXpert® vanA | Predicate (K092953)Xpert® vanA |
| Regulation | Same | 21 CFR §866.1640Antimicrobial susceptibility test powder |
| Product Code | Same | NIJSystem, Test, Genotypic detection, Resistant markers,Enterococcus species |
| Device Class | Same | OOIReal Time Nucleic Acid Amplification SystemClass II |
| Purpose of Use | Same | Identification of the vanA gene sequence that is associatedwith vancomycin-resistant enterococci (VRE) |
| Specimen | Same | Rectal Swab |
| Test Technology | Same | Nucleic Acid (DNA) Amplification (real time PCR) forqualitative detection of vanA with specific primers andTaqMan probes |
| Test Automation | Same | Detection: Fluorogenic target-specific hybridizationFully automated DNA extraction, detection, and resultsinterpretation |
| Test Format | Same | Single-use in disposable, multi-chambered, fluidic cartridge |
| Test Targets(sequence) | Same | vanA |
| Internal Controls | Same | Sample Processing Control (SPC) Probe Check Control (PCC) |
| Time to Results | Same | Less than 45 minutes to results |
| Intended UseEnvironment | Same | Professional Use, by trained users |
| Test Access | Same | Prescription Use only |
Table 2. Similarities between Xpert vanA and the Predicate Device
Table 3. Differences Between Xpert vanA and the Predicate Device
| Differences | ||
|---|---|---|
| Attribute | Modified Device | Predicate (K092953) |
| Xpert® vanA | Xpert® vanA | |
| Intended Use /Indications forUse | The Xpert® vanA test performed on theGeneXpert® Instrument Systems is aqualitative in vitro diagnostic test designedfor detection of the vanA gene sequenceassociated with vancomycin resistance inbacteria obtained from rectal swabspecimens from patients at risk forintestinal colonization with vancomycin-resistant bacteria. The test utilizesautomated real-time polymerase chainreaction (PCR) to detect the vanA genethat is frequently associated withvancomycin-resistant enterococci (VRE). | The Cepheid Xpert® vanA Assayperformed in the GeneXpert® Dx Systemis a qualitative in vitro diagnostic testdesigned for rapid detection of the vanAgene sequence associated withvancomycin resistance in bacteria obtainedfrom rectal swab specimens from patientsat risk for intestinal colonization withvancomycin-resistant bacteria. The testutilizes automated real-time polymerasechain reaction (PCR) to detect the vanAgene that is frequently associated withvancomycin-resistant enterococci (VRE). |
{9}------------------------------------------------
Image /page/9/Picture/1 description: The image shows the Cepheid logo with the text "Xpert vanA" below it. The Cepheid logo consists of a stylized blue wave-like design above the word "Cepheid" in a serif font. Below the logo, the text "Xpert" is followed by a circled "R" symbol, and then "vanA" is written in italics.
| Differences | ||
|---|---|---|
| Attribute | Modified Device | Predicate (K092953) |
| Xpert® vanA | Xpert® vanA | |
| 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. | The Xpert vanA Assay is intended to aid in the recognition, prevention, and control of vancomycin-resistant organisms that colonize patients in healthcare settings. The Xpert vanA Assay 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. | |
| InstrumentSystems | GeneXpert Dx System GeneXpert System with Touchscreen GeneXpert Infinity System | GeneXpert Dx System GeneXpert System with Touchscreen |
| SystemsSoftware forinstrumentfamily | GeneXpert Dx software Cepheid OS software Xpertise software | GeneXpert Dx software Cepheid OS software |
1.5 Summary of Performance Data
The performance of the Xpert vanA test when used with the GeneXpert Infinity System instruments was assessed through verification studies, including a prepared cartridge hold time study and functional testing.
Hold time refers to the duration between the preparation of the cartridge (i.e., addition of sample) and the initiation of the test. The maximum acceptable hold time for a prepared cartridge was verified as 4 hours.
Functional testing was conducted using both contrived positive (vancomycin-resistant (vanA) Enterococcus faecalis cells added to negative matrix) and negative matrix only) samples. The study results showed 100% agreement of reportable results, with no statistically significant differences in Ct values observed between assay runs in instruments of the GeneXpert Dx System and GeneXpert Infinity System. This study demonstrated equivalent performance of the Xpert van 4 test when performed on any member of the GeneXpert® Instrument Systems family.
The assessment of the results from these studies determined that the performance claims of the Xpert vanA test were not impacted by the modifications made to the predicate device.
1.6 Conclusion
The results of the verification studies demonstrated that the performance of the modified Xpert van 4 test on the GeneXpert Infinity System is equivalent to the performance of the predicate
{10}------------------------------------------------
Image /page/10/Picture/0 description: The image shows the logo for Cepheid, a molecular diagnostics company. Below the logo is the text "Xpert® vanA". The Cepheid logo consists of a stylized blue wing-like shape above the company name.
device, the original Xpert vanA (K092953), and that the modifications proposed in the modified device have not changed the fundamental scientific technology of the predicate device.
§ 866.1640 Antimicrobial susceptibility test powder.
(a)
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.(b)
Classification. Class II (performance standards).