(22 days)
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No
The summary describes a qualitative in vitro diagnostic test using real-time PCR and hybridization probes. There is no mention of AI or ML in the intended use, device description, or the specific sections for AI/ML information.
No
The device is described as a qualitative in vitro diagnostic test for detecting specific DNA targets, not for treating or rehabilitating patients.
Yes.
The document explicitly states that the device is a "qualitative in vitro diagnostic test" and is "intended 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."
No
The device is an in vitro diagnostic test that utilizes automated real-time PCR and fluorogenic probes, which are hardware components, and is performed on the GeneXpert Dx System, which is also a hardware system.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicitly stated in the Intended Use: The very first sentence of the "Intended Use / Indications for Use" section clearly states: "The Cepheid Xpert™ MRSA/SA Blood Culture Assay performed on the GeneXpert® Dx System™ is a qualitative in vitro diagnostic test..."
- Performed on patient specimens: The assay is performed directly on patient positive blood cultures, which are biological specimens taken from the human body.
- Provides diagnostic information: The test is intended to detect the presence of specific DNA targets (MRSA/SA) to aid in the detection of these organisms, which is a diagnostic purpose.
- Used in conjunction with other laboratory tests and clinical data: This further reinforces its role as a tool to assist in diagnosis.
The definition of an In Vitro Diagnostic device is a medical device that is used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device fits that definition perfectly.
N/A
Intended Use / Indications for 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.
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/SA Positive results should be reported as such.
Product codes
NQX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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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
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Xpert® MRSA/SA Blood Culture Assay, 510(k) #K082140
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
CONFIDENTIAL
Cepheid.
JUL 2 8 2010
510(k) Summary
As required by 21 CFR Section 807.92(c).
| Submitted by: | Cepheid
904 Caribbean Drive
Sunnyvale, CA 90489
Phone number: (408) 400-8230
Fax 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) and
Staphylococcus aureus (SA) from positive blood culture
bottles assay. |
| Type of Test: | Nucleic Acid Amplification Test, DNA, Methicillin-
resistant Staphylococcus aureus (MRSA) and
Staphylococcus aureus (SA), qualitative |
| Classification name: | Antimicrobial susceptibility test powder |
| Regulation number: | 866.1640 |
| Procode: | NQX |
| Classification
Advisory Committee: | Microbiology |
| Panel: | 83 |
| Predicate Device: | Xpert® MRSA/SA Blood Culture Assay, 510(k) #K082140 |
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.
1
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.
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/SA Positive results should be reported as such.
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.
2
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
4
JUL 2 8 2010
KID1879 510(k) Number (if known):
Xpert MRSA/SA Blood Culture Assay Device Name:
Indications for 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 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.
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) =
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