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

Device 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.

AI/ML Overview

Acceptance Criteria and Study Details for Xpert SA Nasal Complete (K243070)

This submission (K243070) seeks to modify the existing Xpert SA Nasal Complete device (K100822) to include the GeneXpert® Infinity Systems instruments in its compatible instrument family. The study described focuses on demonstrating equivalent performance on the new instrument systems.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly state quantitative acceptance criteria for clinical performance (e.g., sensitivity, specificity) for this specific 510(k) submission (K243070). This is likely because the core assay and its clinical performance were extensively validated and accepted during the original clearance of K100822, and this submission focuses on adding new compatible instruments while demonstrating equivalent performance.

However, based on the studies conducted, the implicit acceptance criteria relate to demonstrating equivalent performance on the new GeneXpert Infinity Systems compared to the predicate device run on previously cleared GeneXpert systems.

Acceptance Criteria (Implied)	Reported Device Performance
Prepared cartridge hold time: Maximum acceptable hold time verified.	4 hours (maximum acceptable hold time verified).
Functional testing: 100% agreement of reportable results for both contrived positive (MRSA) and negative samples.	100% agreement of reportable results.
Functional testing: No statistically significant differences in Ct values observed between assay runs on GeneXpert Dx Systems and GeneXpert Infinity Systems.	No statistically significant differences in Ct values observed.
Overall Performance: Performance claims of the Xpert SA Nasal Complete test not impacted by modifications.	Assessment determined performance claims were not impacted.

2. Sample Size Used for the Test Set and Data Provenance

The document describes two types of studies impacting the acceptance criteria:

Prepared Cartridge Hold Time Study:
- Sample Size: Not explicitly stated. The study involved verifying a maximum acceptable hold time. This would typically involve testing multiple samples at various time points within and beyond the proposed hold time.
- Data Provenance: Not specified, but likely laboratory-based controlled studies.
Functional Testing:
- Sample Size: Not explicitly stated. The study used "both contrived positive (MRSA added to negative matrix) and negative (negative matrix only) samples." It also notes "Each target of the Xpert SA Nasal Complete test was analyzed." This implies a sufficient number of samples to represent positive and negative outcomes for both SA and MRSA targets.
- Data Provenance: Not specified, but based on the description of "contrived positive" and "negative matrix," it is a retrospective laboratory-based study using controlled samples. The materials used (e.g., negative matrix) would be laboratory-sourced.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not Applicable for this particular submission. The ground truth for the functional testing was established by the nature of the contrived samples:

Contrived positive samples: MRSA added to negative matrix, meaning the positive status was known and intentionally created.
Negative samples: Negative matrix only, meaning the negative status was known and intentionally created.

This type of study does not require human expert interpretation to establish the ground truth of the samples.

4. Adjudication Method for the Test Set

Not Applicable. As the ground truth was established by the deliberate creation of contrived positive and negative samples, no adjudication by human experts was required to determine the true status of the samples.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC comparative effectiveness study was not done. This submission (K243070) is for a device modification to expand compatible instruments rather than to assess human reader improvement with AI assistance. The device in question is an automated in vitro diagnostic test that provides a qualitative result (positive/negative) directly, without requiring human interpretation for its primary output.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance study was effectively done. The Xpert SA Nasal Complete test is an automated nucleic acid amplification test (NAAT). The "functional testing" described assesses the device's ability to correctly identify contrived positive and negative samples when run on the new GeneXpert Infinity Systems instruments, independently determining the presence or absence of the target DNA. This is a standalone performance evaluation of the device itself.

7. The Type of Ground Truth Used

The ground truth used for the functional testing was established by the deliberate creation of contrived samples. This includes:

Contrived positive samples: MRSA added to a negative matrix, where the presence of the pathogen (MRSA) is known and controlled.
Negative samples: Negative matrix only, where the absence of the pathogen is known and controlled.

This methods ensures a definitive and known ground truth.

8. The Sample Size for the Training Set

Not applicable/Not explicitly stated. The Xpert SA Nasal Complete test is a PCR-based diagnostic with specific primers and probes for target DNA. It is not typically a machine learning/AI model that undergoes "training" in the traditional sense with a distinct training set. The assay's design (primers, probes, thermocycling protocols) would have been developed and optimized during its initial development, but this isn't referred to as a "training set" in the context of this type of device. The current submission is a modification focusing on instrument compatibility.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As noted above, the concept of a "training set" and its associated ground truth establishment is not directly relevant to this PCR-based diagnostic device in the context of this submission. The assay's analytical performance and target specificity are inherent to its biochemical design.

Summary

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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

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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:

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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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510(k) Summary for Xpert SA Nasal Complete

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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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Cepheid. Xpert® SA Nasal Complete

1 510(k) Summary

As required by 21 CFR Section 807.92.

Submitted by:	Cepheid904 Caribbean DriveSunnyvale, CA 90489Phone 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
ClassificationAdvisory Panel	Microbiology (83)
Prescription Use	Yes
Predicate Device	Xpert SA Nasal Complete (K100822)

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1.1 Device Description

The Xpert SA Nasal Complete test performed on the GeneXpert® Instrument Systems provides results in approximately 65 minutes.

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Instrument FamilyMembers	InstrumentSystems	SystemsSoftware	Instruments
GeneXpert®Instrument Systems	GeneXpert® DxSystems	GeneXpert Dx	GX-I† GX-II GX-II GX-IV GX-XVI
	GeneXpert® Systemwith Touchscreen	Cepheid OS	GX-II GX-IV GX-XVI
	GeneXpert® InfinitySystems	GeneXpertXpertise	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.

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Similarities
Attribute	Modified DeviceXpert® SA Nasal Complete	Predicate (K100822)Xpert® SA Nasal Complete
Regulation	Same	21 CFR 866.1640Antimicrobial susceptibility test powder
Product Code	Same	NQXSystem, Nucleic Acid Amplification Test, DNA,Methicillin Resistant Staphylococcus Aureus, DirectSpecimen
Device Class	Same	OOIReal Time Nucleic Acid Amplification SystemClass II
Purpose of Use	Same	Identification of MRSA and SA
Specimen	Same	Nasal swab
Test Technology	Same	Nucleic Acid (DNA) Amplification (real time PCR) forqualitative detection of Staphylococcus aureus (SA) andMethicillin-resistant S. aureus (MRSA) with specificprimers and TaqMan probes
Test Automation	Same	Detection: Fluorogenic target-specific hybridizationFully-automated DNA extraction, detection, and resultsinterpretation
Test Format	Same	Single-use in disposable, multi-chambered, fluidiccartridge
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 forUse	The Xpert SA Nasal Complete testperformed on the GeneXpert®Instrument Systems is a qualitative invitro diagnostic test designed for detectionof Staphylococcus aureus (SA) andmethicillin-resistant Staphylococcus	The Cepheid® Xpert SA Nasal Completeassay performed in the GeneXpert® DxSystem is a qualitative in vitro diagnostic testdesigned for rapid detection ofStaphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) from

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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 Completeaureus (MRSA) from nasal swabs inpatients at risk for nasal colonization. Thetest utilizes automated real-timepolymerase chain reaction (PCR) to detectMRSA/SA DNA. The Xpert SA NasalComplete test is intended to aid in theprevention and control of MRSA/SAinfections in healthcare settings. The XpertSA Nasal Complete test is not intended todiagnose, guide or monitor treatment forMRSA/SA infections, or provide results ofsusceptibility to methicillin. A negativeresult does not preclude MRSA/SA nasalcolonization. Concomitant cultures arenecessary to recover organisms forepidemiological typing or for furthersusceptibility testing.	Xpert® SA Nasal Completenasal swabs in patients at risk for nasalcolonization. The test utilizes automated real-time polymerase chain reaction (PCR) todetect MRSA/SA DNA. The Xpert SA NasalComplete assay is intended to aid in theprevention and control of MRSA/SAinfections in healthcare settings. The XpertSA Nasal Complete assay is not intended todiagnose, guide or monitor treatment forMRSA/SA infections, or provide results ofsusceptibility to methicillin. A negative resultdoes not preclude MRSA/SA nasalcolonization. Concomitant cultures arenecessary to recover organisms forepidemiological typing or for furthersusceptibility testing.
InstrumentSystems	GeneXpert Dx Systems GeneXpert System with Touchscreen GeneXpert Infinity-48s and Infinity-80 Systems	GeneXpert Dx Systems GeneXpert System with Touchscreen
SystemsSoftware forinstrumentfamily	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.

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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.

Regulation Number and Section

§ 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).