Xpert Carba-R

K160901 · Cepheid · POC · Jun 29, 2016 · Microbiology

Device Facts

• Record ID: K160901
• Device Name: Xpert Carba-R
• Applicant: Cepheid
• Product Code: POC · Microbiology
• Decision Date: Jun 29, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1640
• Device Class: Class 2

Intended Use

The Xpert® Carba-R Assay, performed on the GeneXpert® Instrument Systems, is a qualitative in vitro diagnostic test designed for the detection and differentiation of the blakpc, blaNDM, blaym, blaoxA-48, and blamp gene sequences associated with carbapenem-non-susceptibility. The test utilizes automated real-time polymerase chain reaction (PCR). The Xpert Carba-R Assay is intended as an aid to infection control in the detection of carbapenem-non-susceptible bacteria that colonize patients in healthcare settings. The Xpert Carba-R Assay is not intended to guide or monitor treatment for carbapenem-nonsusceptible bacterial infections. A negative Xpert Carba-R Assay result does not preclude the presence of other resistance mechanisms. The Xpert Carba R-Assay is for use with the following sample types: Rectal Swab Specimens The assay is performed on rectal swab specimens from patients at risk for intestinal colonization with carbapenem-non-susceptible bacteria. Concomitant cultures are necessary to recover organisms for epidemiological typing, antimicrobial susceptibility testing, and for further confirmatory bacterial identification. Pure Colonies The assay is performed on carbapenem-non-susceptible pure colonies of Enterobacteriaceae, Acinetobacter baumannii, or Pseudomonas aeruginosa, when grown on blood agar or MacConkey agar. For testing pure colonies, the Xpert Carba-R Assay should be used in conjunction with other laboratory tests including phenotypic antimicrobial susceptibility testing.

Device Story

Automated real-time PCR assay for qualitative detection of carbapenemase gene sequences (blaKPC, blaNDM, blaVIM, blaOXA-48, blaIMP). Input: rectal swab specimens resuspended in sample reagent. Process: single-use, multi-chambered fluidic cartridge performs automated sample preparation, DNA extraction, amplification, and real-time detection on GeneXpert Instrument Systems. Output: detected/not detected results for each target gene. Used in healthcare settings for infection control monitoring. Healthcare providers use results to identify colonized patients; does not guide treatment. Benefits: rapid (approx. 50 min) identification of resistance markers to support infection control measures.

Clinical Evidence

Multi-site prospective clinical study (n=755 eligible specimens) and contrived specimen study (n=432). Compared against culture and bi-directional DNA sequencing. Prospective PPA ranged 60.0%-100% and NPA 98.6%-99.9% across targets. Contrived PPA 95%-100%, NPA 100%. Reproducibility study demonstrated high agreement across sites, operators, and lots.

Technological Characteristics

Automated real-time PCR; disposable multi-chambered fluidic cartridges; ultrasonic horn for cell lysis; I-CORE® thermocycler; TaqMan® probes; internal Sample Processing Control (SPC) and Probe Check Control (PCC). Standalone instrument system (GeneXpert Dx/Infinity).

Indications for Use

Indicated for patients at risk for intestinal colonization with carbapenem-non-susceptible bacteria. Used for qualitative detection and differentiation of blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP gene sequences from rectal swab specimens. Not for bacterial identification or reporting susceptibility status. Not for guiding/monitoring treatment.

Regulatory Classification

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.

Predicate Devices

• Xpert Carba-R Assay (K152614)

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 29, 2016

CEPHEID JIM KELLY, Ph.D. EXECUTIVE DIRECTOR, REGULATORY AFFAIRS 904 CARIBBEAN DRIVE SUNNYVALE CA 94089-1189

Re: K160901

Trade/Device Name: Xpert® Carba-R Assay Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: II Product Code: POC, OOI Dated: March 31, 2016 Received: April 1, 2016

Dear Dr. Kelly:

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. 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.

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 Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Ribhi Shawar -S

For Uwe Scherf, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known) K160901

Device Name

Xpert Carba-R

#### Indications for Use (Describe)

The Xpert® Carba-R Assay, performed on the GeneXpert® Instrument Systems, is a qualitative in vitro diagnostic test designed for the detection and differentiation of the blaker, blaNDM, blayIM, blackA-48, and blanny gene sequences associated with carbapenem-non-susceptibility. The test utilizes automated real-time polymerase chain reaction (PCR),

The Xpert Carba-R Assay is intended as an aid to infection of carbapenem-non- susceptible bacteria that colonize patients in healthcare settings. The Xpert Carba-R Assay is not intended to guide or monitor treatmannon-susceptible bacterial infections. A negative Xpert Carba-R Assay result does not preclude the presence of other resistance mechanisms.

The Xpert Carba-R Assay is for use with the following sample types:

Rectal Swab Specimens

The assay is performed on rectal swab specimens at risk for intestinal colonization with carbapenem-non-susceptible bacteria. Concomitant cultures are necessary to reanisms for epidemiological typing, antimicrobial susceptibility testing, and for further confirmatory bacterial identification.

Pure Colonies

The assay is performed on carbapenen-non-susceptible pure colonies of Enterobacter baumanni, or Pseudomonas aeruginosa, when grown on blood agar or MacConkey agar. For testing pure colonies, the Xpert Carba-R Assay should be used in conjunction with other laboratory tests including phenotypic antimicrobial 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

Product code:

Classification

Advisory Panel

Prescription Use

Predicate Device

Assay:

As required by 21 CFR Section 807.92(c).

| Submitted by: | Cepheid<br>904 Caribbean Drive<br>Sunnyvale, CA 90489<br>Phone number: [phone]<br>Fax number: [phone] |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Scott A. Campbell, PhD, MBA |
| Date of Preparation: | June 28, 2016 |
| Device: | |
| Trade name: | Xpert ^® Carba-R |
| Common name: | Xpert Carba-R Assay |
| Type of Test: | Qualitative nucleic acid amplification test of the bla _KPC , bla _NDM ,<br>bla _VIM , bla _OXA-48 , and bla _IMP gene sequences associated with<br>carbapenem-non-susceptibility in gram-negative bacteria<br>obtained from rectal swab specimens |
| Classification: | II |
| Regulation number: | 866.1640 |
| Classification name: | Antimicrobial susceptibility test powder |

POC, OOI

Yes

Microbiology (83)

[510(k) #K152614]

Cepheid Xpert ® Carba-R

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## Device Description:

The Xpert Carba-R Assay is an automated real-time polymerase chain reaction (PCR) in vitro diagnostic test for qualitative detection of the blaxpc, blaym, blaoxa-a8, and blamp gene sequences from rectal swab specimens. The Xpert Carba-R Assay is intended as an aid for infection control for monitoring the spread of carbapenem-nonsusceptible organisms in healthcare settings.

The Xpert Carba-R Assay is performed on the Cepheid GeneXpert® Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpert Infinity-80 systems). The GeneXpert Instrument System platform automates sample preparation. amplification and real-time detection.

The GeneXpert Instrument Systems require the use of single-use, disposable cartridges (the Xpert Carba-R cartridges) that hold the PCR reagents and host the PCR process. Because the cartridges are self-contained and specimens never come into contact with working parts of the instrument modules, cross-contamination between samples is minimized.

The Xpert Carba-R Assay cartridges contain reagents for the detection of blakec, blanDM, blaym, blaox 8-8, and blance gene sequences. A Sample Processing Control (SPC) and a Probe Check Control (PCC) are controls utilized by the GeneXpert Instrument System platform. The SPC is present to control for adequate processing of the target bacteria and to monitor the presence of inhibitors in the real-time PCR reaction to reduce the possibility of false negative results. The PCC verifies reagent rehydration, real-time PCR tube filling in the cartridge, probe integrity, and dye stability.

The single-use, multi-chambered fluidic cartridges are designed to complete sample preparation and real-time PCR for the detection of the blaker, blanny, blaoxA-48. and blank gene sequences from rectal swab specimens in approximately 50 minutes. The GeneXpert Instrument Systems, comprised of the GeneXpert Dx Systems and the GeneXpert Infinity Systems, have 1 to 80 randomly accessible modules, depending upon the instrument, that are each capable of performing separate sample processing and realtime PCR and RT- 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 RT-PCR and detection.

Rectal swab specimens are placed into a sample reagent. The sample is transferred to the sample chamber of the disposable fluidic cartridge (the Xpert Carba-R cartridge). The user initiates a test from the system user interface and places the cartridge into the GeneXpert instrument platform, which performs hands-off real-time, multiplex PCR for detection of the blaker, blaypy, blaym, blaoxy-48, and blane gene sequences. The results are automatically generated at the end of the process in a report that can be viewed and printed.

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## Device Intended Use:

The Xpert® Carba-R Assay, performed on the GeneXpert® Instrument Systems, is a qualitative in vitro diagnostic test designed for the detection and differentiation of the blakpc, blaNDM, blaoxA-48, and blamp gene sequences associated with carbapenem-non-susceptibility. The test utilizes automated real-time polymerase chain reaction (PCR).

The Xpert Carba-R Assay is intended as an aid to infection control in the detection of carbapenem-non-susceptible bacteria that colonize patients in healthcare settings. The Xpert Carba-R Assay is not intended to guide or monitor treatment for carbapenem-nonsusceptible bacterial infections. A negative Xpert Carba-R Assay result does not preclude the presence of other resistance mechanisms.

The Xpert Carba R-Assay is for use with the following sample types:

## Rectal Swab Specimens

The assay is performed on rectal swab specimens from patients at risk for intestinal colonization with carbapenem-non-susceptible bacteria. Concomitant cultures are necessary to recover organisms for epidemiological typing, antimicrobial susceptibility testing, and for further confirmatory bacterial identification.

## Pure Colonies

The assay is performed on carbapenem-non-susceptible pure colonies of Enterobacteriaceae, Acinetobacter baumannii, or Pseudomonas aeruginosa, when grown on blood agar or MacConkey agar. For testing pure colonies, the Xpert Carba-R Assay should be used in conjunction with other laboratory tests including phenotypic antimicrobial susceptibility testing.

## Substantial Equivalence:

The Cepheid Xpert Carba-R Assay is substantially equivalent to the Xpert® Carba-R Assay, 510(k) #K152614. Both assays utilize the same GeneXpert cartridge and detect target gene sequences (blakec, blandM, blavM, blaoxA-48, and blamp) using real-time PCR amplification and fluorogenic target-specific hybridization detection. The performance of the Xpert Carba-R Assay for an expanded indication was determined in a multi-site clinical study in which the performance of the Xpert Carba-R Assay was evaluated relative to culture and reference DNA sequence analysis. The results of the study demonstrated that the performance of the Xpert Carba-R Assay is substantially equivalent to the predicate device. Please refer to K152614 for information on the performance of the Xpert Carba-R Assay with pure colonies of carbapenem nonsusceptible Enterobacteriaceae, Acinetobacter baumannii, and Pseudomonas aeruginosa.

Table 5-1 shows the similarities and differences between the Xpert Carba-R Assay and the predicate device.

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# Table 5-1: Comparison of Similarities and Differences of the Xpert Carba-R Assay with the Predicate Device

| Similarities | | |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | Device | Predicate Device |
| | Cepheid Xpert Carba-R Assay | Cepheid Xpert Carba-R Assay<br>K152614 |
| General Intended Use | The Xpert® Carba-R Assay, performed<br>on the GeneXpert® Instrument Systems,<br>is a qualitative <i>in vitro</i> diagnostic test<br>designed for the detection and<br>differentiation of the <i>blaKPC</i> ,<br><i>blaNDM</i> , <i>blaVIM</i> , <i>blaOXA-48</i> , and<br><i>blaIMP</i> gene sequences associated with<br>carbapenem-non-susceptibility. The<br>test utilizes automated real-time<br>polymerase chain reaction (PCR).<br><br>The Xpert Carba-R Assay is intended as<br>an aid to infection control in the<br>detection of carbapenem-non-susceptible<br>bacteria that colonize patients in<br>healthcare settings. The Xpert Carba-R Assay is not intended to guide or<br>monitor treatment for carbapenem-<br>non-susceptible bacterial infections. A<br>negative Xpert Carba-R Assay result<br>does not preclude the presence of other<br>resistance mechanisms.<br><br>The Xpert Carba-R Assay is for use with<br>the following sample types:<br>Rectal Swab Specimens<br><br>The assay is performed on rectal swab<br>specimens from patients at risk for<br>intestinal colonization with carbapenem-<br>non-susceptible bacteria. Concomitant<br>cultures are necessary to recover<br>organisms for epidemiological typing,<br>antimicrobial susceptibility testing, and<br>for further confirmatory bacterial<br>identification.<br><br>Pure Colonies<br><br>The assay is performed on carbapenem-<br>non-susceptible pure colonies of<br><i>Enterobacteriaceae</i> , <i>Acinetobacter</i><br><i>baumannii</i> , or <i>Pseudomonas aeruginosa</i> ,<br>when grown on blood agar or<br>MacConkey agar. For testing pure<br>colonies, the Xpert Carba-R Assay<br>should be used in conjunction with other | The Xpert® Carba-R Assay, performed<br>on the GeneXpert® Instrument Systems,<br>is a qualitative <i>in vitro</i> diagnostic test for<br>the detection and differentiation of the<br><i>blaKPC</i> , <i>blaNDM</i> , <i>blaVIM</i> , <i>blaOXA</i> -<br>48, and <i>blaIMP</i> gene sequences<br>associated with carbapenem-non-<br>susceptible pure colonies of<br><i>Enterobacteriaceae</i> , <i>Acinetobacter</i><br><i>baumannii</i> , or <i>Pseudomonas</i><br><i>aeruginosa</i> grown on blood agar or<br>MacConkey agar. The test utilizes<br>automated real-time polymerase chain<br>reaction (PCR).<br><br>A negative Xpert Carba-R Assay<br>result does not preclude the presence<br>of other resistance mechanisms. The<br>Xpert Carba-R Assay should be used<br>in conjunction with other laboratory<br>tests including phenotypic<br>antimicrobial susceptibility testing.<br>The Xpert Carba-R Assay is intended<br>as an aid for infection control in<br>detecting and differentiating genetic<br>markers of resistance to monitor the<br>spread of carbapenem-non-susceptible<br>organisms in healthcare settings. The<br>Xpert Carba-R Assay is not<br>intended to guide or monitor<br>treatment for carbapenem-non-<br>susceptible bacterial infections. |
| Similarities | | |
| Item | Device | Predicate Device |
| | Cepheid Xpert Carba-R Assay | Cepheid Xpert Carba-R Assay<br>K152614 |
| Type of test | laboratory tests including phenotypic<br>antimicrobial susceptibility testing. | Qualitative |
| Technological<br>Principles | Same | Fully-automated nucleic acid<br>amplification (DNA); real-time<br>PCR |
| Test Cartridge | Same | Disposable single-use, multi-chambered<br>fluidic cartridge |
| Probes | Same | TaqMan® Probes |
| Controls | Same | Internal sample processing<br>control (SPC) and probe<br>check control (PCC)<br>External controls available |
| Instrument System | Same | GeneXpert Instrument System<br>(includes GeneXpert Dx, Infinity-48,<br>Infinity-48s, and Infinity-80) |
| Time to obtain test<br>results | Same | Approximately 50 minutes to results |
| Interpretation of test<br>results | Same | Diagnostic software of the GeneXpert<br>Instrument System |
| Laboratory Users | Same | Operators in CLIA Moderate or High<br>Complexity labs |
| Differences | | |
| Item | Cepheid Xpert Carba-R Assay | Cepheid Xpert Carba-R Assay<br>K152614 |
| Sample Types | Bacterial isolates from culture, rectal<br>swab specimens | Bacterial isolates from culture |

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The Xpert Carba-R Assay has the same general intended use as the predicate device and has the same technological characteristics as the predicate device. The differences between the Xpert Carba-R Assay and the predicate device do not raise questions of safety and effectiveness. The clinical study demonstrates that the Xpert Carba-R Assay is acceptable for its intended use with inexperienced laboratory users and is substantially equivalent to the predicate device described above.

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## Non-Clinical Studies:

## Analytical Sensitivity (Limit of Detection)

The analytical sensitivity or Limit of Detection (LoD) of the Xpert Carba-R Assay was assessed using carbapenemase-producing organisms seeded into pooled negative human rectal swab matrix. The LoD was determined for two carbapenemase-producing bacteria for each gene analyte.i.e., the genes encoding KPC, NDM, VIM, OXA-48, and IMP. Bacteria were titered by plate counts and spiked onto clean swabs. Swabs were placed into pooled negative rectal swab matrix and replicates of 20 were evaluated at a minimum of five different concentrations over four days. The LoD for each of the ten carbapenemaseproducing organisms was estimated by probit analysis. The LoD is defined as the lowest concentration of target cells (CFU/swab) that can be reproducibly distinguished from negative samples with 95% confidence. The study was performed with two different lots of Xpert Carba-R reagents and the claimed LoD is the higher of the two determinations. The estimated LoDs were verified by preparing and testing 10 replicates from two independent dilutions of each bacterium at each estimated LoD.

The claimed LoD for each pair of carbapenemase-producing organism in rectal swab matrix are shown in Table 5-2.

| Target Gene and Organism | LoD Estimates (Probit)<br>CFU /swab | | LoD<br>Claim<br>CFU/swab | Estimated<br>LoD<br>In Sample<br>Reagent<br>CFU/mL | Verification<br>(Positives/20) |
|----------------------------------------------|-------------------------------------|-------|--------------------------|----------------------------------------------------|--------------------------------|
| | Lot 1 | Lot 2 | | | |
| IMP-1 Acinetobacter baumannii | 174 | 141 | 174 | 35 | 20/20 |
| IMP-1 Klebsiella pneumoniae | 303 | 306 | 306 | 61 | 20/20 |
| VIM-1 Klebsiella pneumoniae | 247 | 305 | 305 | 61 | 20/20 |
| VIM-4 Escherichia coli | 815 | 468 | 815 | 163 | 20/20 |
| NDM-1 Klebsiella pneumoniae ATCC<br>BAA-2146 | 117 | 251 | 251 | 50 | 20/20 |
| NDM Klebsiella pneumoniae | 74 | 57 | 74 | 15 | 19/20 |
| KPC-3 Klebsiella pneumoniae NCTC<br>13438 | 373 | 292 | 373 | 75 | 20/20 |
| KPC Enterobacter cloacae | 779 | 537 | 779 | 156 | 20/20 |
| OXA-48 Enterobacter cloacae | 154 | 109 | 154 | 31 | 20/20 |
| OXA-48 Escherichia coli | 104 | 99 | 104 | 21 | 20/20 |

Table 5-2. LoD Estimates and Verification for Organisms Harboring Carbapenemase Genes using the Xpert Carba-R Assay in Rectal Swab Matrix

# An…