The Cepheid Xpert™ MRSA/SA Blood Culture Assay performed on 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) DNA directly from patient positive blood cultures. The assay utilizes automated real-time polymerase chain reaction (PCR) for the amplification of MRSA/SA specific DNA targets and fluorogenic target-specific hybridization probes for the real-time detection of the amplified DNA. The assay is performed directly on positive blood culture specimens using BD BACTEC™ Plus Aerobic/F blood culture bottles that are determined as Gram Positive Cocci in Clusters (GPCC) or as Gram Positive Cocci in singles (GPC) by Gram stain. The Xpert MRSA/SA Blood Culture Assay is indicated for use in conjunction with other laboratory tests, such as culture, and clinical data available to the clinician as an aid in the detection of MRSA/SA from patient positive blood cultures. Subculturing of positive blood cultures is necessary to recover organisms for susceptibility testing or for epidemiological typing. The Cepheid Xpert™ MRSA/SA Blood Culture Assay is not intended to monitor treatment for MRSA/SA infections.

When an MRSA negative/SA positive result is obtained, the result should be interpreted as "MRSA indeterminate/SA Positive, antimicrobial susceptibility testing pending". Further testing should be performed using an FDA-cleared, phenotypic antimicrobial susceptibility testing method on isolated colonies recovered from the blood culture bottle. MRSA positive results should be reported as such.

Device Description

The Cepheid Xpert® MRSA/SA Blood Culture Assay (Xpert MRSA/SA Blood Culture Assay) is a rapid, automated DNA test for simultaneously detecting MRSA and SA directly from positive blood culture specimens. The assay is performed on the Cepheid GeneXpert Dx System.

AI/ML Overview

This summary is based on the provided text, which refers to a 510(k) submission for a device modification rather than a new study. Therefore, the information typically associated with a new study's acceptance criteria and performance data is not fully present. The document explicitly states that the device is "substantially equivalent" to a previously cleared predicate device and that "the only changes that have been made to the new device are to the package insert, as directed by the agency." This means there wasn't a new clinical study to establish performance against acceptance criteria for this specific submission.

However, I can extract the relevant information regarding the equivalence claim and the device itself.

1. Table of Acceptance Criteria and Reported Device Performance

Since this 510(k) is for a modification (package insert changes) to an already cleared device, there are no new acceptance criteria or device performance metrics presented in this document. The device's performance is implicit in its substantial equivalence to the predicate device, which would have undergone its own performance evaluation.

Performance Metric	Acceptance Criteria (from a new study)	Reported Device Performance (from a new study)
N/A	There are no new performance metrics or associated acceptance criteria presented in this 510(k) submission as the changes are limited to the package insert and the device is deemed substantially equivalent to a predicate.	There is no new performance data presented for this specific 510(k) submission. Performance is based on the previously cleared predicate device (K082140).

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

Not applicable for this 510(k) submission as no new performance study was conducted. The document focuses on the substantial equivalence of the modified device to its predicate, primarily due to labeling changes.

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

Not applicable for this 510(k) submission as no new performance study was conducted.

4. Adjudication Method for the Test Set

Not applicable for this 510(k) submission as no new performance study was conducted.

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

No, an MRMC comparative effectiveness study was not done for this 510(k) submission. The document explicitly states that the changes are related to the package insert, and the device is substantially equivalent to a predicate.

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

The device itself is an automated DNA test ("Nucleic Acid Amplification Test, DNA, Methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA), qualitative") performed on the Cepheid GeneXpert Dx System. Therefore, it inherently operates in a standalone manner (algorithm only) to detect MRSA/SA DNA. However, this specific 510(k) is not presenting a new standalone performance study, but rather confirming the substantial equivalence of a modified version of an already cleared standalone device. The device's intended use also states that it's "indicated for use in conjunction with other laboratory tests, such as culture, and clinical data available to the clinician." This implies that while the algorithm provides a result, clinical interpretation involves other human-generated data.

7. The Type of Ground Truth Used

Not explicitly stated in this document for this specific submission as no new performance testing was conducted. For the predicate device, the ground truth for detecting MRSA/SA from positive blood cultures would typically be established through microbiology culture and subsequent identification and susceptibility testing (e.g., phenotypic methods) of the isolated organisms.

8. The Sample Size for the Training Set

Not applicable for this 510(k) submission as no new training was performed for a device modification involving only package insert changes.

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

Not applicable for this 510(k) submission as no new training was performed.

Summary

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K101879

CONFIDENTIAL

Cepheid.

JUL 2 8 2010

510(k) Summary

As required by 21 CFR Section 807.92(c).

Submitted by:	Cepheid904 Caribbean DriveSunnyvale, CA 90489Phone number: (408) 400-8230Fax number: (408) 541-6439
Contact:	Russel K. Enns, Ph.D.
Date of Preparation:	June 30, 2010
Device:
Trade name:	Xpert® MRSA/SA Blood Culture Assay
Common name:	Methicillin-resistant Staphylococcus aureus (MRSA) andStaphylococcus aureus (SA) from positive blood culturebottles assay.
Type of Test:	Nucleic Acid Amplification Test, DNA, Methicillin-resistant Staphylococcus aureus (MRSA) andStaphylococcus aureus (SA), qualitative
Classification name:	Antimicrobial susceptibility test powder
Regulation number:	866.1640
Procode:	NQX
ClassificationAdvisory Committee:	Microbiology
Panel:	83
Predicate Device:	Xpert® MRSA/SA Blood Culture Assay, 510(k) #K082140

Device Description:

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Device Intended Use:

The Cepheid Xpert™ MRSA/SA Blood Culture Assay performed on 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) DNA directly from patient positive blood cultures. The assay utilizes automated realtime polymerase chain reaction (PCR) for the amplification of MRSA/SA specific DNA targets and fluorogenic target-specific hybridization probes for the real-time detection of the amplified DNA. The assay is performed directly on positive blood culture specimens using BD BACTEC™ Plus Aerobic/F blood culture bottles that are determined as Gram Positive Cocci in Clusters (GPCC) or as Gram Positive Cocci in singles (GPC) by Gram stain. The Xpert MRSA/SA Blood Culture Assay is indicated for use in conjunction with other laboratory tests, such as culture, and clinical data available to the clinician as an aid in the detection of MRSA/SA from patient positive blood cultures. Subculturing of positive blood cultures is necessary to recover organisms for susceptibility testing or for epidemiological typing. The Cepheid Xpert™ MRSA/SA Blood Culture Assay is not intended to monitor treatment for MRSA/SA infections.

Substantial Equivalence:

The Xpert MRSA/SA Blood Culture Assay is substantially equivalent to the predicate device (Xpert MRSA/SA Blood Culture Assay; 510(k) #K082140, cleared on September 9, 2008). The two devices are identical in composition and technological characteristics: the only changes that have been made to the new device are to the package insert, as directed by the agency. The primary change includes the addition of a warning box statement to the Intended Use Statement, with related labeling changes to support the warning statement. The intended use of the device to detect Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) DNA directly from patient positive blood cultures has not changed.

Conclusion:

The Xpert MRSA/SA Blood Culture Assay with the labeling modifications is substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

2010

Russel K. Enns, Ph.D. Senior Vice President Chief Regulatory Officer Cepheid® 904 Caribbean Drive Sunnyvale CA 94089-1189

Re: K101879

Trade/Device Name: Cepheid Xpert™ MRSA/SA Blood Culture Assay

Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: Class II Product Code: NQX Dated: July 2, 2010 Received: July 6, 2010

Dear Dr. Enns:

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 (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. 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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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

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Page 2 - Russel K. Enns, Ph.D.

CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Saly attyns

Sally A. Hojvat, Ph.D Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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JUL 2 8 2010

KID1879 510(k) Number (if known):

Xpert MRSA/SA Blood Culture Assay Device Name:

Indications for Use:

Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) =

Page 1 of 1

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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).