(28 days)
Not Found
No
The description focuses on automated real-time PCR and integrated hardware/software for sample processing and detection, with no mention of AI or ML algorithms for data analysis or interpretation.
No
Explanation: This device is an in vitro diagnostic test designed for the detection of specific bacteria (Staphylococcus aureus and MRSA) from nasal swabs. Its purpose is to aid in the prevention and control of infections by providing diagnostic information, not to directly treat or provide therapy to a patient. The text explicitly states it is "not intended to diagnose, guide or monitor treatment for MRSA/SA infections".
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is a "qualitative in vitro diagnostic test." It also mentions "The Xpert SA Nasal Complete test is intended to aid in the prevention and control of MRSA/SA infections in healthcare settings." The "Device Description" further clarifies it as an "automated in vitro diagnostic DNA 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 used to run the tests and view results, the core functionality and components are hardware-based.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicitly stated in the Intended Use/Indications for Use: The very first sentence clearly states, "The Xpert® SA Nasal Complete test performed on the GeneXpert® Instrument Systems is a qualitative in vitro diagnostic test..."
- Device Description confirms in vitro nature: The device description further reinforces this by stating it's an "automated in vitro diagnostic DNA test".
- Analyzes samples outside the body: The test is performed on nasal swabs, which are collected from the patient and then analyzed in the laboratory setting using the GeneXpert instrument. This is the core characteristic of an in vitro diagnostic.
- Provides diagnostic information: While it's not intended for diagnosis or treatment monitoring, it is intended to "aid in the prevention and control of MRSA/SA infections in healthcare settings" by detecting the presence of these organisms. This is a diagnostic purpose, even if it's for colonization rather than active infection.
N/A
Intended Use / 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 Staphylococus 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.
Product codes (comma separated list FDA assigned to the subject device)
NQX, OOI
Device Description
The Xpert SA Nasal Complete 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 nasal 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 different, uniquely-labeled chamber of the disposable fluidic cartridge (the Xpert SA Nasal Complete cartridge). The user initiates a test from the user interface of the GeneXpert® Instrument Systems and places the cartridge with sample into the GeneXpert® Instrument System platform, which performs hands-off real-time, multiplex polymerase chain reaction (PCR) for detection of S. aureus (including MRSA) DNA.
In the GeneXpert® Instrument Systems (comprised of the GeneXpert® Dx Systems, GeneXpert® System with Touchscreen, and GeneXpert® Infinity Systems), 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, the GeneXpert® Instrument Systems 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 SA Nasal Complete test kit includes reagents for the simultaneous detection of SA and MRSA targets. The primers and probes provided in the Xpert SA Nasal Complete test kit detects 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 Xpert SA Nasal Complete cartridge 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 Probe Check Control (PCC) verifies reagent rehydration, PCR tube filling in the cartridge, probe integrity, and dve stability.
The Xpert SA Nasal Complete test performed on the GeneXpert® Instrument Systems provides results in approximately 65 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nasal swabs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Professional Use, by trained users in healthcare settings.
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 SA Nasal Complete test when used with the GeneXpert Infinity Systems 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 added to negative matrix) and negative (negative matrix only) samples. Each target of the Xpert SA Nasal Complete 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 Systems and GeneXpert Infinity Systems. This study demonstrated equivalent performance of the Xpert SA Nasal Complete 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 SA Nasal Complete test were not impacted by the modifications made to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
100% agreement of reportable results, with no statistically significant differences in Ct values observed between assay runs in instruments of the GeneXpert Dx Systems and GeneXpert Infinity Systems.
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
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 25, 2024
Cepheid Bansari Doshi Regulatory Affairs Specialist 904 Caribbean Drive Sunnyvale, California 94089
Re: K243070
| Trade/Device Name: | Xpert SA Nasal Complete |
|---|---|
| Regulation Number: | 21 CFR 866.1640 |
| Regulation Name: | Antimicrobial Susceptibility Test Powder |
| Regulatory Class: | Class II |
| Product Code: | NQX, OOI |
| Dated: | September 27, 2024 |
| Received: | September 27, 2024 |
Dear Bansari Doshi:
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, 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
1
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).
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, 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 Rue"). 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.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR $807.97). For questions regarding 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 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 Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure:
2
Indications for Use
510(k) Number (if known) K243070
Device Name Xpert® SA Nasal Complete
Indications for Use (Describe)
The Xpert® SA Nasal Complete test pert® Instrument Systems is a qualitative in vitro diagnostic test designed for detection of Staphylococus 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.
| 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 SA Nasal Complete
4
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 |
5
Cepheid. Xpert® SA Nasal Complete
1 510(k) Summary
As required by 21 CFR Section 807.92.
| Submitted by: | Cepheid
904 Caribbean Drive
Sunnyvale, CA 90489
Phone number: (408) 541-4191 |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Bansari Doshi, M.S. |
| Date of Preparation: | September 27, 2024 |
| Trade name | Xpert® SA Nasal Complete |
| Common name | Xpert SA Nasal Complete |
| 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 (primary), OOI |
| Classification
Advisory Panel | Microbiology (83) |
| Prescription Use | Yes |
| Predicate Device | Xpert SA Nasal Complete (K100822) |
6
1.1 Device Description
The Xpert SA Nasal Complete 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 nasal 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 different, uniquely-labeled chamber of the disposable fluidic cartridge (the Xpert SA Nasal Complete cartridge). The user initiates a test from the user interface of the GeneXpert® Instrument Systems and places the cartridge with sample into the GeneXpert® Instrument System platform, which performs hands-off real-time, multiplex polymerase chain reaction (PCR) for detection of S. aureus (including MRSA) DNA.
In the GeneXpert® Instrument Systems (comprised of the GeneXpert® Dx Systems, GeneXpert® System with Touchscreen, and GeneXpert® Infinity Systems), 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, the GeneXpert® Instrument Systems 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 SA Nasal Complete test kit includes reagents for the simultaneous detection of SA and MRSA targets. The primers and probes provided in the Xpert SA Nasal Complete test kit detects 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 Xpert SA Nasal Complete cartridge 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 Probe Check Control (PCC) verifies reagent rehydration, PCR tube filling in the cartridge, probe integrity, and dve stability.
The Xpert SA Nasal Complete test performed on the GeneXpert® Instrument Systems provides results in approximately 65 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
| Instrument Family
Members | Instrument
Systems | Systems
Software | Instruments |
|----------------------------------|---------------------------------------|-----------------------|----------------------------------------------|
| GeneXpert®
Instrument Systems | GeneXpert® Dx
Systems | GeneXpert Dx | GX-I† GX-II GX-II GX-IV GX-XVI |
| | GeneXpert® System
with Touchscreen | Cepheid OS | GX-II GX-IV GX-XVI |
| | GeneXpert® Infinity
Systems | GeneXpert
Xpertise | GeneXpert Infinity-48s GeneXpert Infinity-80 |
Table 1. Instrument Systems and Software in the GeneXpert® Instrument Family Members
- No longer manufactured but is in circulation in the market
1.2 Device Intended 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.
1.3 Technical Characteristics
The Xpert SA Nasal Complete 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 SA Nasal Complete) to include the GeneXpert® Infinity Systems instruments (see Table 1 above). The Xpert SA Nasal Complete was originally cleared for use on the GeneXpert® Dx System (K100822). Both the GeneXpert Dx System and GeneXpert Infinity Systems 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 SA Nasal Complete test and predicate device. The differences between Xpert SA Nasal Complete test and predicate device do not raise different questions of safety and effectiveness.
8
| Similarities | ||
|---|---|---|
| Attribute | Modified Device | |
| Xpert® SA Nasal Complete | Predicate (K100822) | |
| Xpert® SA Nasal Complete | ||
| Regulation | Same | 21 CFR 866.1640 |
| Antimicrobial susceptibility test powder | ||
| Product Code | Same | NQX |
| System, Nucleic Acid Amplification Test, DNA, | ||
| Methicillin Resistant Staphylococcus Aureus, Direct | ||
| Specimen | ||
| Device Class | Same | OOI |
| Real Time Nucleic Acid Amplification System | ||
| Class II | ||
| Purpose of Use | Same | Identification of MRSA and SA |
| Specimen | Same | Nasal swab |
| Test Technology | Same | Nucleic Acid (DNA) Amplification (real time PCR) for |
| qualitative detection of Staphylococcus aureus (SA) and | ||
| Methicillin-resistant S. aureus (MRSA) with specific | ||
| primers and TaqMan probes | ||
| Test Automation | Same | Detection: Fluorogenic target-specific hybridization |
| 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 ) Methicillin/oxacillin resistance ( mecA ) Staphylococcal chromosomal cassette (SCC mec ) |
Table 2. Similarities between Xpert SA Nasal Complete and the Predicate Device
Staphylococcal chromosomal cassette (SCCCmec) ● insertion event into S. aureus chromosomal attB site Sample Processing Control (SPC) ● Internal Controls Same . Probe Check Control (PCC) Intended Use Professional Use, by trained users Same environment Prescription Use only Test Access Same
Table 3. Differences between Xpert SA Nasal Complete and the Predicate Device
| Differences | ||
|---|---|---|
| Attribute | Modified Device | Predicate (K100822) |
| Xpert® SA Nasal Complete | Xpert® SA Nasal Complete | |
| Time to Results | Approximately 65 minutes | Approximately 50 minutes |
| Intended Use / | ||
| 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 | The Cepheid® Xpert SA Nasal Complete | |
| assay performed in the GeneXpert® Dx | ||
| System is a qualitative in vitro diagnostic test | ||
| designed for rapid detection of | ||
| Staphylococcus aureus (SA) and methicillin- | ||
| resistant Staphylococcus aureus (MRSA) from |
9
Image /page/9/Picture/1 description: The image shows the logo for Cepheid, a molecular diagnostics company. The logo features a stylized blue graphic above the company name in a clean, modern font. Below the company name is the text "Xpert® SA Nasal Complete", which likely refers to one of Cepheid's diagnostic products.
| Differences | ||
|---|---|---|
| Attribute | Modified Device | Predicate (K100822) |
| Xpert® SA Nasal Complete | ||
| 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. | Xpert® SA Nasal Complete | |
| 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 assay is intended to aid in the | ||
| prevention and control of MRSA/SA | ||
| infections in healthcare settings. The Xpert | ||
| SA Nasal Complete assay 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. | ||
| Instrument | ||
| Systems | GeneXpert Dx Systems GeneXpert System with Touchscreen GeneXpert Infinity-48s and Infinity-80 Systems | GeneXpert Dx Systems GeneXpert System with Touchscreen |
| Systems | ||
| Software for | ||
| instrument | ||
| family | GeneXpert Dx software Cepheid OS software Xpertise software | GeneXpert Dx software Cepheid OS software |
Summary of Performance Data 1.5
The performance of the Xpert SA Nasal Complete test when used with the GeneXpert Infinity Systems 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 added to negative matrix) and negative (negative matrix only) samples. Each target of the Xpert SA Nasal Complete 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 Systems and GeneXpert Infinity Systems. This study demonstrated equivalent performance of the Xpert SA Nasal Complete 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 SA Nasal Complete test were not impacted by the modifications made to the predicate device.
10
1.6 Conclusion
The results of the verification studies demonstrated that the performance of the modified Xpert SA Nasal Complete test on the GeneXpert Infinity Systems is equivalent to the performance of the predicate device, the original Xpert SA Nasal Complete (K100822) and that the modifications proposed in K243070 have not changed the fundamental scientific technology of the predicate device.