(23 days)
Not Found
No
The description focuses on automated PCR technology and does not mention AI or ML.
No
The device is an in vitro diagnostic test used to detect specific genetic material (Staphylococcus aureus and MRSA) from skin and soft tissue infection swabs, aiding in diagnosis rather than providing direct therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is a qualitative in vitro diagnostic test."
No
The device is an in vitro diagnostic test that utilizes a physical instrument system (GeneXpert® Instrument Systems) and disposable cartridges containing reagents to perform automated real-time PCR. While software is involved in controlling the instrument and processing data, the core functionality and components are hardware and chemical-based.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicitly Stated: The "Intended Use / Indications for Use" section clearly states: "The Xpert® MRSA/SA Skin and Soft Tissue Infection test (Xpert MRSA/SA SSTI test) performed on the GeneXpert® Instrument Systems is a qualitative in vitro diagnostic test..."
- Purpose: The test is intended for the detection of specific pathogens (Staphylococcus aureus and methicillin-resistant Staphylococcus aureus) from human specimens (skin and soft tissue infection swabs). This is a core function of an in vitro diagnostic device.
- Method: It utilizes automated real-time polymerase chain reaction (PCR) to detect DNA, which is a common technique used in IVD tests.
- Use in Conjunction with Other Tests: The intended use mentions it is "indicated for use in conjunction with other laboratory tests, such as microbiology culture, and clinical data available to the clinician as an aid in the detection of MRSA/SA". This further reinforces its role as a diagnostic tool used in a laboratory setting.
- Device Description: The "Device Description" also refers to it as an "automated in vitro diagnostic DNA test".
All of these points confirm that the Xpert MRSA/SA SSTI test is an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Xpert® MRSA/SA Skin and Soft Tissue Infection test (Xpert MRSA/SA SSTI test) performed on the GeneXpert® Instrument Systems is a qualitative in vitro diagnostic test intended for the detection of Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) from skin and soft tissue infection swabs. The test utilizes automated real-time polymerase chain reaction (PCR) to detect MRSA/SA DNA. The Xpert MRSA/SA SSTI test is indicated for use in conjunction with other laboratory tests, such as microbiology culture, and clinical data available to the clinician as an aid in the detection of MRSA/SA from skin and soft tissue infections. The Xpert MRSA/SA SSTI test is not intended to monitor treatment for MRSA/SA infections. Concomitant cultures for SA and MRSA are necessary to recover organisms for susceptibility testing or epidemiological typing. In a mixed culture containing MRSA/SA and other organisms (e.g., Gram-negative bacilli, yeast), results can be false negative or variable depending on the concentration of MRSA/SA present, particularly if the concentration of MRSA/SA is close to the limit of detection (LoD) of the test.
Product codes (comma separated list FDA assigned to the subject device)
NQX, OOI
Device Description
The Xpert MRSA/SA SSTI (Xpert MRSA/SA Skin and Soft Tissue Infection) test is an automated in vitro diagnostic DNA test for the qualitative, simultaneous detection of Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) directly from skin and soft tissue specimen swabs. The specimen is collected on a double swab, one of which is placed in a tube containing elution reagent. Following brief vortexing, the eluted material is transferred to a different, uniquely labeled sample chamber of a disposable fluidic cartridge (the Xpert MRSA/SA SSTI cartridge).
The test is performed on the GeneXpert® Instrument Systems (comprised of the GeneXpert® Dx System, GeneXpert® System with Touchscreen, and GeneXpert® Infinity System). In the GeneXpert® Instrument Systems, sample preparation, amplification, and real-time detection are all fully automated and completely integrated. The platform requires the use of singleuse disposable cartridges that hold the PCR reagents and host the PCR process. Because the cartridges are self-contained, cross-contamination between samples is minimized.
The user initiates a test from the system user interface of the GeneXpert® Instrument Systems platform and places the cartridge with sample into a GeneXpert® instrument system which performs hands-off real-time, multiplex polymerase chain reaction (PCR) for detection of SA and MRSA DNA.
Depending upon the specific instrument, a GeneXpert® instrument system may contain 1–80 modules, each 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 ICORE® thermocycler for performing real-time PCR and detection.
The Xpert MRSA/SA SSTI test kit includes reagents for the simultaneous detection of the target organisms, SA and MRSA. The primers and probes in the Xpert MRSA/SA SSTI test detect nucleic acid sequences of the staphylococcal protein A (spa), the gene for methicillin/oxacillin resistance (mecA), and staphylococcal cassette chromosome (SCCmec) inserted in the SA chromosomal attB site.
The test includes a 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 MRSA/SA SSTI test performed on the GeneXpert® Instrument Systems provides results in approximately 62 minutes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin and soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Professional Use, by trained users
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance of the Xpert MRSA/SA SSTI 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 (MRSA cells added to negative matrix) and negative (negative matrix only) samples. Each target of the Xpert MRSA/SA SSTI test was analyzed, resulting in a reportable outcome. 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 MRSA/SA SSTI 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 MRSA/SA SSTI test were not impacted by the modifications made to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
December 18, 2024
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Cepheid Vidhi Shah Regulatory Affairs Senior Specialist 904 Caribbean Drive Sunnyvale, California 94089
Re: K243625
| Trade/Device Name: | Xpert MRSA/SA SSTI |
|---|---|
| Regulation Number: | 21 CFR §866.1640 |
| Regulation Name: | Antimicrobial Susceptibility Test Powder |
| Regulatory Class: | Class II |
| Product Code: | NQX, OOI |
| Dated: | November 22, 2024 |
| Received: | November 25, 2024 |
Dear Vidhi Shah:
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 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).
1
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 (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) 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-devices/medical-device-safety/medical-device-reporting-mdrhow-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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 OPEQ: Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure:
2
Indications for Use
510(k) Number (if known) K243625
Device Name Xpert® MRSA/SA SSTI
Indications for Use (Describe)
The Xpert® MRSA/SA Skin and Soft Tissue Infection test (Xpert MRSA/SA SSTI test) performed on the GeneXpert® Instrument Systems is a qualitative in vitro diagnostic test intended for the detection of Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) from skin and soft tissue infection swabs. The test utilizes automated real-time polymerase chain reaction (PCR) to detect MRSA/SA SSTI test is indicated for use in conjunction with other laboratory tests, such as microbiology culture, and clinical data available to the clinician as an aid in the detection of MRSA/SA from skin and soft tissue infections. The Xpert MRSA/SA SSTI test is not intended to monitor treatment for MRSA/SA infections. Concomitant cultures for SA and MRSA are necessary to recover organisms for susceptibility testing or epidemiological typing. In a mixed culture containing MRSA/SA and other organisms (e.g., Gram-negative bacilli, yeast), results can be false negative or variable depending on the concentration of MRSA/SA present, particularly if the concentration of MRSA/SA is close to the limit of detection (LoD) of the test.
| Type of Use (Select one or both, as applicable) | |
|---|---|
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary for Xpert MRSA/SA SSTI
4
Image /page/4/Picture/0 description: The image shows the logo for Cepheid, a molecular diagnostics company. The logo features a stylized blue swoosh above the company name, "Cepheid.". Below the company name is the text "Xpert® MRSA/SA SSTI", which likely refers to one of Cepheid's diagnostic tests for detecting methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA) in skin and soft tissue infections (SSTI).
TABLE OF CONTENTS
| 1 | 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 |
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Image /page/5/Picture/0 description: The image shows the Cepheid logo and the text "Xpert® MRSA/SA SSTI". The Cepheid logo is a stylized blue shape above the word "Cepheid.". The text "Xpert® MRSA/SA SSTI" is below the logo in a smaller font.
1 510(k) Summary
As required by 21 CFR §807.92.
| Submitted by: | Cepheid
904 Caribbean Drive
Sunnyvale, CA 90489
Phone Number: (408) 541-4191 |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Vidhi Shah, Senior Regulatory Affairs Specialist |
| Date of Preparation: | November 22, 2024 |
| Device: | |
| Trade name | Xpert® MRSA/SA SSTI |
| Common name | Xpert MRSA/SA SSTI |
| Type of Test | Nucleic Acid Amplification Test, DNA, Staphylococcus aureus
(SA) and Methicillin-resistant Staphylococcus aureus (MRSA),
qualitative |
| Regulation number: | 21 CFR §866.1640 |
| Classification name: | Antimicrobial susceptibility test powder |
| Product code: | NQX, OOI |
| Classification
Advisory Panel | Microbiology (83) |
| Prescription Use | Yes |
| Predicate Device
Assay: | Xpert MRSA/SA SSTI (K080837) |
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Image /page/6/Picture/1 description: The image shows the Cepheid logo, which includes a blue graphic element above the word "Cepheid." Below the logo is the text "Xpert® MRSA/SA SSTI". The text appears to be the name of a product or service offered by Cepheid.
1.1 Device Description
The Xpert MRSA/SA SSTI (Xpert MRSA/SA Skin and Soft Tissue Infection) test is an automated in vitro diagnostic DNA test for the qualitative, simultaneous detection of Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) directly from skin and soft tissue specimen swabs. The specimen is collected on a double swab, one of which is placed in a tube containing elution reagent. Following brief vortexing, the eluted material is transferred to a different, uniquely labeled sample chamber of a disposable fluidic cartridge (the Xpert MRSA/SA SSTI cartridge).
The test is performed on the GeneXpert® Instrument Systems (comprised of the GeneXpert® Dx System, GeneXpert® System with Touchscreen, and GeneXpert® Infinity System). In the GeneXpert® Instrument Systems, sample preparation, amplification, and real-time detection are all fully automated and completely integrated. The platform requires the use of singleuse disposable cartridges that hold the PCR reagents and host the PCR process. Because the cartridges are self-contained, cross-contamination between samples is minimized.
The user initiates a test from the system user interface of the GeneXpert® Instrument Systems platform and places the cartridge with sample into a GeneXpert® instrument system which performs hands-off real-time, multiplex polymerase chain reaction (PCR) for detection of SA and MRSA DNA.
Depending upon the specific instrument, a GeneXpert® instrument system may contain 1–80 modules, each 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 ICORE® thermocycler for performing real-time PCR and detection.
The Xpert MRSA/SA SSTI test kit includes reagents for the simultaneous detection of the target organisms, SA and MRSA. The primers and probes in the Xpert MRSA/SA SSTI test detect nucleic acid sequences of the staphylococcal protein A (spa), the gene for methicillin/oxacillin resistance (mecA), and staphylococcal cassette chromosome (SCCmec) inserted in the SA chromosomal attB site.
The test includes a 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 MRSA/SA SSTI test performed on the GeneXpert® Instrument Systems provides results in approximately 62 minutes.
7
Image /page/7/Picture/1 description: The image shows the logo for Cepheid, a molecular diagnostics company. Below the logo is the text "Xpert® MRSA/SA SSTI". The text likely refers to a diagnostic test for methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA) skin and soft tissue infections (SSTI).
Each instrument in the GeneXpert® instrument family is equipped with Windows OS-based personal computer preloaded with software applications for running tests and viewing the results, as described in Table 1.
| Table 1: Instrument Systems and Software in the GeneXpert® Instrument Family |
|---|
| Members |
| Instrument Family | Instrument Family
Members | Systems Software
specific to Instrument
Family Member | GeneXpert® Instruments |
|----------------------------------|---------------------------------------|-------------------------------------------------------------|----------------------------------------------|
| GeneXpert®
Instrument Systems | GeneXpert® Dx
System | GeneXpert Dx | GX-I† GX-II GX-IV GX-XVI |
| | GeneXpert® System
with Touchscreen | Cepheid OS | GX-II GX-IV GX-XVI |
| | GeneXpert®
Infinity System | GeneXpert Xpertise | GeneXpert Infinity-48s GeneXpert Infinity-80 |
T No longer manufactured or distributed in the United States but is in circulation in the market
1.2 Device Intended Use
The Xpert® MRSA/SA Skin and Soft Tissue Infection test (Xpert MRSA/SA SSTI test) performed on the GeneXpert® Instrument Systems is a qualitative in vitro diagnostic test intended for the detection of Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) from skin and soft tissue infection swabs. The test utilizes automated real-time polymerase chain reaction (PCR) to detect MRSA/SA DNA. The Xpert MRSA/SA SSTI test is indicated for use in conjunction with other laboratory tests, such as microbiology culture, and clinical data available to the clinician as an aid in the detection of MRSA/SA from skin and soft tissue infections. The Xpert MRSA/SA SSTI test is not intended to monitor treatment for MRSA/SA infections. Concomitant cultures for SA and MRSA are necessary to recover organisms for susceptibility testing or epidemiological typing. In a mixed culture containing MRSA/SA and other organisms (e.g., Gram-negative bacilli, yeast), results can be false negative or variable depending on the concentration of MRSA/SA present. particularly if the concentration of MRSA/SA is close to the limit of detection (LoD) of the test.
1.3 Technical Characteristics
The Xpert MRSA/SA SSTI 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 MRSA/SA SSTI) to include the GeneXpert® Infinity System instruments (see Table 1 above). The Xpert MRSA/SA SSTI test was originally cleared for use on the GeneXpert® Dx System (K080837). Both the GeneXpert Dx System and the GeneXpert Infinity System are
8
Image /page/8/Picture/0 description: The image shows the Cepheid logo with the text "Xpert® MRSA/SA SSTI" underneath it. The Cepheid logo consists of a stylized blue wing-like shape above the word "Cepheid." The text "Xpert® MRSA/SA SSTI" is written in a smaller font size than the word "Cepheid."
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 MRSA/SA SSTI test and predicate device. The differences between Xpert MRSA/SA SSTI test and predicate device do not raise different questions of safety and effectiveness.
| Table 2. Similarities between Xpert MRSA/SA SSTI and the Predicate Device | |||
|---|---|---|---|
| Similarities | ||
|---|---|---|
| Attribute | Modified Device | |
| Xpert® MRSA/SA SSTI | Predicate (K080837) Device | |
| Xpert® MRSA/SA SSTI | ||
| Regulation | Same | 21 CFR §866.1640 |
| Product Code | Same | Antimicrobial susceptibility test powder |
| NQX | ||
| System, Nucleic Acid Amplification Test, DNA, Methicillin | ||
| Resistant Staphylococcus Aureus, Direct Specimen | ||
| Device Class | Same | ΟΟΙ |
| Real Time Nucleic Acid Amplification System | ||
| Class II | ||
| Purpose of Use | Same | Identification of Staphylococcus aureus (SA) and |
| Methicillin-resistant Staphylococcus aureus (MRSA) | ||
| Specimen | Same | Skin and soft tissue infection swabs |
| Test Technology | Same | Nucleic Acid (DNA) Amplification (real time PCR) for |
| qualitative detection of SA and MRSA with specific primers | ||
| and TaqMan probes | ||
| Detection: Fluorogenic target-specific hybridization | ||
| Test Automation | Same | Fully automated DNA extraction, detection, and results |
| interpretation | ||
| Test Format | Same | Single use in disposable, multi-chambered, fluidic cartridge |
| Test Targets | ||
| (Sequence) | Same | Staphylococcal protein A (spa gene), sequence specific |
| to S. aureus species Sequence specific to Methicillin/oxacillin resistance | ||
| (mecA gene) Sequence incorporating the insertion site (attBssc) of | ||
| Staphylococcal Cassette Chromosome mec (SCCmec) | ||
| for detection of MRSA | ||
| Internal Controls | Same | Sample Processing Control (SPC) Probe Check Control (PCC) |
| Intended Use | ||
| environment | Same | Professional Use, by trained users |
| Test Access | Same | Prescription Use only |
9
Image /page/9/Picture/1 description: The image contains the logo for Cepheid, a molecular diagnostics company. The logo features a stylized blue graphic element above the company name, "Cepheid." Below the company name is the text "Xpert® MRSA/SA SSTI", which likely refers to a specific diagnostic test offered by Cepheid for detecting MRSA and Staphylococcus aureus in skin and soft tissue infections.
| Table 3. Differences between Xpert MRSA/SA SSTI and the Predicate Device |
|---|
| -------------------------------------------------------------------------- |
| Differences | ||
|---|---|---|
| Attribute | Modified Device | Predicate(K080837) |
| Xpert® MRSA/SA SSTI | Xpert® MRSA/SA SSTI | |
| Time to Results | Approximately 62 minutes | Approximately 50 minutes |
| Intended | ||
| Use/Indications | ||
| for Use | The Xpert® MRSA/SA Skin and Soft Tissue | |
| Infection test (Xpert® MRSA/SA SSTI test) | ||
| performed on the GeneXpert® Instrument | ||
| Systems is a qualitative in vitro diagnostic | ||
| test intended for the detection of | ||
| Staphylococcus aureus (SA) and | ||
| methicillin-resistant Staphylococcus aureus | ||
| (MRSA) from skin and soft tissue infection | ||
| swabs. The test utilizes automated real-time | ||
| polymerase chain reaction (PCR) to detect | ||
| MRSA/SA DNA. The Xpert MRSA/SA | ||
| SSTI test is indicated for use in conjunction | ||
| with other laboratory tests, such as | ||
| microbiology culture, and clinical data | ||
| available to the clinician as an aid in the | ||
| detection of MRSA/SA from skin and soft | ||
| tissue infections. The Xpert MRSA/SA | ||
| SSTI test is not intended to monitor | ||
| treatment for MRSA/SA infections. | ||
| Concomitant cultures for SA and MRSA are | ||
| necessary to recover organisms for | ||
| susceptibility testing or epidemiological | ||
| typing. In a mixed culture containing | ||
| MRSA/SA and other organisms (e.g., | ||
| Gram-negative bacilli, yeast), results can be | ||
| false negative or variable depending on the | ||
| concentration of MRSA/SA present, | ||
| particularly if the concentration of | ||
| MRSA/SA is close to the limit of detection | ||
| (LoD) of the test. | The Cepheid Xpert MRSA/SA Skin and | |
| Soft Tissues Infection Assay (Xpert® | ||
| MRSA/SA SSTI Assay) performed in the | ||
| GeneXpert® Dx System is a qualitative in | ||
| vitro diagnostic test intended for the | ||
| detection of Staphylococcus aureus (SA) | ||
| and methicillin-resistant Staphylococcus | ||
| aureus (MRSA) from skin and soft tissue | ||
| infection swabs. The test utilizes automated | ||
| real-time polymerase chain reaction (PCR) | ||
| to detect MRSA/SA DNA. The Xpert | ||
| MRSA/SA SSTI Assay is indicated for use | ||
| in conjunction with other laboratory tests | ||
| such as microbiology culture, and clinical | ||
| data available to the clinician as an aid in the | ||
| detection of MRSA/SA from skin and | ||
| soft tissue infections. The Xpert MRSA/SA | ||
| SSTI Assay is not intended to monitor | ||
| treatment for MRSA/SA infections. | ||
| Concomitant cultures for SA and MRSA | ||
| are necessary to recover organisms for | ||
| susceptibility testing or epidemiological | ||
| typing. | ||
| In a mixed culture containing MRSA/SA | ||
| and other organisms (e.g. Gram negative | ||
| bacilli, yeast), results can be false negative | ||
| or variable depending on the concentration | ||
| of MRSA/SA present, particularly if the | ||
| concentration of MRSA/SA is close to the | ||
| LoD of the assay. | ||
| Instrument | ||
| Systems | GeneXpert Dx System | |
| GeneXpert System with Touchscreen | ||
| GeneXpert Infinity System | GeneXpert Dx System | |
| GeneXpert System with Touchscreen | ||
| Systems Software | ||
| for Instrument | ||
| Family | 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 MRSA/SA SSTI test when used with the GeneXpert® Infinity System instruments was assessed through verification studies, including a prepared cartridge hold time study and functional testing.
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Image /page/10/Picture/1 description: The image shows the Cepheid logo, which includes a stylized blue wing-like design above the word "Cepheid." Below the logo, the text "Xpert® MRSA/SA SSTI" is displayed. The text likely refers to a diagnostic test or product related to MRSA/SA SSTI, which are types of bacterial infections.
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 (MRSA cells added to negative matrix) and negative (negative matrix only) samples. Each target of the Xpert MRSA/SA SSTI test was analyzed, resulting in a reportable outcome. 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 MRSA/SA SSTI 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 MRSA/SA SSTI 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 MRSA/SA SSTI test on the GeneXpert Infinity System is equivalent to the performance of the predicate device, the original Xpert MRSA/SA SSTI (K080837), and that the modifications proposed in the modified device have not changed the fundamental scientific technology of the predicate device.