GenePOC Carba

K190275 · Genepoc, Inc. · PMY · May 10, 2019 · Microbiology

Device Facts

• Record ID: K190275
• Device Name: GenePOC Carba
• Applicant: Genepoc, Inc.
• Product Code: PMY · Microbiology
• Decision Date: May 10, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1640
• Device Class: Class 2

Intended Use

The GenePOC™ Carba assay, performed on the revogene™ instrument, is a qualitative in vitro diagnostic test designed for the detection and differentiation of the blakec. blaNDM, blackA-48-like, and blamp gene sequences associated with carbapenem-nonsusceptible pure colonies of Enterobacteriaceae, Acinetobacter baumannii, or Pseudomonas aeruginosa, when grown on blood agar or MacConkey agar. The test utilizes automated real-time Polymerase Chain Reaction (PCR). The GenePOC™ Carba assay should be used in conjunction with other laboratory tests including phenotypic antimicrobial susceptibility testing. A negative GenePOC™ Carba assay result does not preclude the presence of other resistance mechanisms. The GenePOC™ Carba assay is intended as an aid for infection control in the detection of carbapenem-non-susceptible bacteria that colonize patients in healthcare settings. The identification of a bland, blaym or blaviM metallo-B-lactamase gene (i.e., the genes that encode the IMP, NDM and VIM metallo-ß-lactamases, respectively) may be used as an aid to clinicians in determining appropriate therapeutic strategies for patients with known or suspected carbapenem non-susceptible infections.

Device Story

The GenePOC™ Carba assay is an automated, qualitative in vitro diagnostic test performed on the revogene™ instrument. It processes pure bacterial colonies (Enterobacteriaceae, A. baumannii, P. aeruginosa) grown on blood or MacConkey agar. The user prepares a 0.5 McFarland suspension, transfers it to a Sample Buffer Tube, and loads it into a single-use, closed microfluidic cartridge (PIE). The revogene™ instrument automates homogenization, cell lysis, DNA extraction, and real-time PCR amplification. The device detects five carbapenemase gene families (blaKPC, blaNDM, blaVIM, blaOXA-48-like, blaIMP) using fluorogenic TaqMan® probes. Results are automatically generated in approximately 70 minutes. The output aids clinicians in infection control and determining therapeutic strategies for patients with suspected carbapenem-resistant infections. The system includes an internal process control (PrC) to verify sample processing and amplification.

Clinical Evidence

Clinical study evaluated 512 compliant isolates (Enterobacteriaceae, A. baumannii, P. aeruginosa) across three sites. Performance was compared to an FDA-cleared NAAT reference method. Sensitivity and specificity were calculated for each target gene. For blood agar, sensitivity ranged from 98.9% to 100% and specificity from 96.1% to 99.8% across targets. Discrepant analysis using alternative PCR and bi-directional sequencing confirmed that some discordant results were due to differences in variant coverage between the subject and reference methods.

Technological Characteristics

Real-time PCR-based assay. Components: disposable microfluidic cartridge (PIE) with glass beads for lysis, Sample Buffer Tube, Transfer Tool. Energy: electrical (revogene instrument). Connectivity: barcode readers for sample/reagent ID; no wireless transmission. Software: automated result interpretation. Sterilization: not specified.

Indications for Use

Indicated for qualitative detection and differentiation of blaKPC, blaNDM, blaVIM, blaOXA-48-like, and blaIMP gene sequences in carbapenem-non-susceptible pure colonies of Enterobacteriaceae, Acinetobacter baumannii, or Pseudomonas aeruginosa. For use in healthcare settings as an infection control aid. Not for bacterial identification or sub-typing. Prescription use only.

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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 10, 2019

GenePOC Inc. Dany Leblanc VP QA/RA 360 rue Franquet Quebec, G1P 4N3 Ca

Re: K190275

Trade/Device Name: GenePOC Carba Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: PMY, OOI Dated: February 6, 2019 Received: February 8, 2019

Dear Dany Leblanc:

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. 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 located 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.

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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR

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803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for

Uwe Scherf, M.Sc., Ph.D. Director Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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#### 510(K) SUMMARY 5.0

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#### 510K SUMMARY

#### 510(k) Number: K190275

#### A. GENERAL INFORMATION

Submission Date: April 29, 2019

Submitter Information:

| <i>Submitted By:</i> | GenePOC Inc.<br>360 rue Franquet<br>Québec (Québec) G1P 4N3 |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| <i>Contact Person:</i> | Dany Leblanc<br>VP Quality Assurance and Regulatory Affairs<br>GenePOC Inc.<br>Telephone: [phone]<br>Email: [e-mail] |

#### B. PURPOSE FOR SUBMISSION

To obtain a substantial equivalence determination for the GenePOC™ Carba assay on the revogene™ instrument for the qualitative detection and differentiation of the blaxer, blayDM, blayM, blaoxA-48-ike, and blamp gene sequences from carbapenem-non-susceptible pure colonies of Enterobacteriaceae, Acinetobacter baumannii, or Pseudomonas aeruginosa.

#### C. MEASURAND

Target DNA sequence of the following genes: blakec, blandM, blaving, blaoxA-48like, and blanp

#### D. TYPE OF TEST

Qualitative real-time Polymerase Chain Reaction (PCR) assay

#### E. APPLICANT

GenePOC Inc.

#### F. PROPRIETARY AND ESTABLISHED NAMES

Proprietary Name: GenePOC™ Carba Common Name : GenePOC™ Carba assay

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#### G. REGULATORY INFORMATION

| Trade Name: | GenePOC™ Carba |
|------------------|------------------------------------------|
| Classification: | Class II |
| Regulation: | 21 CFR 866.1640 |
| Regulation Name: | Antimicrobial susceptibility test powder |
| Product Code: | PMY, OOI |
| Panel: | 83 - Microbiology |

#### H. INTENDED USE

- 1. Intended Use and Indications for Use:
The GenePOC™ Carba assay, performed on the revogene™ instrument, is a qualitative in vitro diagnostic test designed for the detection and differentiation of the blakec. blaNDM, blackA-48-like, and blamp gene sequences associated with carbapenem-nonsusceptible pure colonies of Enterobacteriaceae, Acinetobacter baumannii, or Pseudomonas aeruginosa, when grown on blood agar or MacConkey agar. The test utilizes automated real-time Polymerase Chain Reaction (PCR).

The GenePOC™ Carba assay should be used in conjunction with other laboratory tests including phenotypic antimicrobial susceptibility testing. A negative GenePOC™ Carba assay result does not preclude the presence of other resistance mechanisms.

The GenePOC™ Carba assay is intended as an aid for infection control in the detection of carbapenem-non-susceptible bacteria that colonize patients in healthcare settings. The identification of a bland, blaym or blaviM metallo-B-lactamase gene (i.e., the genes that encode the IMP, NDM and VIM metallo-ß-lactamases, respectively) may be used as an aid to clinicians in determining appropriate therapeutic strategies for patients with known or suspected carbapenem non-susceptible infections.

- 2. Special conditions for use statement(s):
Prescription Use Only

Organisms should be identified and carbapenem non-susceptibility status should be determined prior to testing with the GenePOCTM Carba assay.

The GenePOC™ Carba assay detects blakec, blandM, blavisM, blaoxA-48-like, and blamp resistance genes from pure colonies and is not for bacterial identification.

The performance of the GenePOC™ Carba assay with bacteria other than Enterobacteriaceae, Acinetobacter baumannii or Pseudomonas aeruginosa, has not been evaluated.

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The GenePOC™ Carba assay is not a sub-typing tool and does not report variants of the blakpc, blandm, blaym, blaoxa-48-like, and blandp

- 3. Special instrument requirements:
The GenePOC™ Carba assay uses PCR technology on the revogene™ instrument platform, which extracts, amplifies, and detects the target DNA.

#### I. INDICATIONS FOR USE

Same as Intended Use.

#### J. DEVICE DESCRIPTION

The GenePOC™ Carba assay is an automated real-time polymerase chain reaction (PCR) in vitro diagnostic test for the qualitative detection and differentiation of the blaype, blayDM, blavin, blaoxA-48-ike, and blamp gene sequences in carbapenem-non-susceptible pure colonies of Enterobacteriaceae, Acinetobacter baumannii, or Pseudomonas aeruginosa grown on blood agar or MacConkey agar. The GenePOC™ Carba assay is designed to be performed on the revogene™ instrument. The revogene™ is an instrument that automates sample homogenization, sample dilution, cells lysis, DNA amplification, and detection of the amplified PCR products.

The GenePOC™ Carba assay kit is comprised of single-use, disposable microfluidic cartridges (PIEs), Sample Buffer Tubes (SBT), and Disposable Transfer Tools (DTT). These components are used to dilute the sample, extract, amplify, and simultaneously detect blayDM, blavin, blaoxA-48-like, and blamp DNA. A Process Control (PrC) is also incorporated into each PIE to verify sample processing and amplification steps. The PrC allows for the verification of potential inhibitor substances as well as microfluidic, instrument or reagent failure.

Each GenePOC™ Carba assay kit contains 24 individual pouches. Each pouch has components for one (1) test including one (1) Carba PIE, one (1) SBT, and one (1) DTT. The single-use, multi-chambered fluidic cartridges are designed to complete sample preparation and real-time PCR for the detection of the blaker, blands, blaoxa-48-like, and blanyp gene sequences from isolates of pure cultures of carbapenem-non-susceptible gram-negative bacteria in approximately 70 minutes. User intervention is only required for preparing the standardized 0.5 McFarland bacterial suspension from characterized carbapenem-non-susceptible isolated colonies, inoculating the bacterial suspension into the Sample Buffer Tube (SBT), transferring the sample into the single-use disposable PIE, and loading/unloading the PIEs into the revogene™ carousel. Each PIE is a completely integrated closed device in which a sample is dispensed and processed through different microfluidic chambers and channels that allow for the sample processing and subsequent real-time PCR steps.

Upon completion of a run, the results are interpolated by the revogene™ from measured fluorescent signals and embedded calculation algorithms. The output results include positive, negative, indeterminate, and unresolved. Upon completion of a run, the user removes the used

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cartridges and disposes of them in normal biological waste. The results are automatically generated at the end of the process in a report that can be viewed and printed.

### K. SUBSTANTIAL EQUIVALENCE INFORMATION

- 1. Predicate Device Name: Xpert® Carba-R Assay
- 2. Predicate 510(k) Number: K152614
- 3. Comparison with Predicate:

The GenePOC™ Carba assay is substantially equivalent to the Xpert® Carba-R Assay (K152614). The GenePOC™ Carba and the Xpert Carba-R assays both detect target gene sequences from antibiotic-non-susceptible bacteria and use real-time PCR amplification and fluorogenic target-specific hybridization detection. The performance of the GenePOC™ Carba assay was determined in a multi-site clinical study. The table below shows the similarities and differences between the GenePOC™ Carba assay and the predicate device (Xpert® Carba-R Assay).

| Item | GenePOCT™ Carba assay | Xpert® Carba-R Assay<br>(Predicate Device) |
|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K Number | K190275 | K152614 |
| SIMILARITIES | | |
| Classification | Class II | Class II |
| Intended Use | The GenePOC™ Carba assay, performed on<br>the revogene™ instrument, is a qualitative<br><i>in vitro</i> diagnostic test designed for the<br>detection and differentiation of the blaKPC,<br>blaNDM, blaVIM, blaOXA-48-like, and blaIMP<br>gene sequences associated with<br>carbapenem-non-susceptible pure colonies<br>of <i>Enterobacteriaceae</i> , <i>Acinetobacter<br/>baumannii</i> , or <i>Pseudomonas aeruginosa</i> ,<br>when grown on blood agar or MacConkey<br>agar. The test utilizes automated real-time<br>Polymerase Chain Reaction (PCR).<br><br>The GenePOC™ Carba assay should be<br>used in conjunction with other laboratory<br>tests including phenotypic antimicrobial<br>susceptibility testing. A negative<br>GenePOC™ Carba assay result does not<br>preclude the presence of other resistance<br>mechanisms.<br><br>The GenePOC™ Carba assay is intended as<br>an aid for infection control in the detection<br>of carbapenem-non-susceptible bacteria that<br>colonize patients in healthcare settings. The<br>identification of a blaKPC, blaNDM or blaVIM | The Xpert® Carba-R Assay,<br>performed on the GeneXpert®<br>Instrument Systems, is a qualitative<br><i>in vitro</i> diagnostic test for the<br>detection and differentiation of the<br>blaKPC, blaNDM, blaVIM, blaOXA-48,<br>and blaIMP gene sequences<br>associated with carbapenem-non-<br>susceptible pure colonies of<br><i>Enterobacteriaceae</i> , <i>Acinetobacter<br/>baumannii</i> , or <i>Pseudomonas<br/>aeruginosa</i> grown on blood agar or<br>MacConkey agar. The test utilizes<br>automated real-time polymerase<br>chain reaction (PCR).<br><br>A negative Xpert Carba-R Assay<br>result does not preclude the<br>presence of other resistance<br>mechanisms. The Xpert Carba-R<br>Assay should be used in conjunction<br>with other laboratory tests including<br>phenotypic antimicrobial<br>susceptibility testing. The Xpert<br>Carba-R Assay is intended as an aid<br>for infection control in detecting |
| Item | GenePOCT™ Carba assay | Xpert® Carba-R Assay<br>(Predicate Device) |
| | metallo-β-lactamase gene (i.e., the genes<br>that encode the IMP, NDM and VIM<br>metallo-β-lactamases, respectively) may be<br>used as an aid to clinicians in determining<br>appropriate therapeutic strategies for<br>patients with known or suspected<br>carbapenem non-susceptible infections. | and differentiating genetic markers<br>of resistance to monitor the spread<br>of carbapenem-non-susceptible<br>organisms in healthcare settings.<br>The Xpert Carba-R Assay is not<br>intended to guide or monitor<br>treatment for carbapenem-non-<br>susceptible bacterial infections. |
| Technological<br>Principles | Automated nucleic acid amplification; real-<br>time PCR | Same |
| Test Cartridge | Disposable single-use, multi-chambered<br>fluidic cartridge | Same |
| Detection Probes | TaqMan® Probes | Same |
| Assay Targets | Detects blaKPC, blaNDM, blaVIM, blaOXA-48-like,<br>and blaIMP genes. | Same |
| Sample Preparation | Automated | Same |
| Interpretation of Test<br>Results | Automated | Same |
| Sample Type | Bacterial isolates from culture | Same |
| Organisms | Enterobacteriaceae, Pseudomonas<br>aeruginosa, Acinetobacter baumannii | Same |
| DIFFERENCES | | |
| Instrument System | revogene™ | GeneXpert Instrument System<br>(includes GeneXpert Dx, Infinity-<br>48, Infinity-48s, and Infinity-80) |
| Time to Obtain Test<br>Results | Approximately 70 minutes | Approximately 50 minutes |
| | KPC-2, 3, 4 | KPC-2, 3, 4 |
| Variant Type(s)<br>Detected (based on<br>analytical studies) 1 | NDM-1, 4 to 7 | NDM-1, 2, 4, 5 |
| | IMP-1, 4, 8, 9, 11 | IMP-1, 2, 4, 6, 10, 11 |
| | OXA-48, 181, 204, 232 | OXA-48, 181 |
| | VIM-1, 2, 10, 19 | VIM-1, 2, 4, 10, 19 |
| Variant Types(s) Not<br>Detected (based on<br>analytical studies) 1 | None | IMP-7, 13, 14 |
| | KPC-5 to 38 | KPC-5 to 16 |
| | NDM-2, 3, 8 to 24 | NDM-3, 6 to 9 |
| Additional Detectable<br>Variant Types(s)<br>Predicted from in<br>silico analysis1 | IMP-2, 5, 6, 10, 13 to 20, 23 to 26, 28 to 30,<br>32, 33, 37, 38, 40, 42, 45, 47 to 49, 53 to 56,<br>59, 60, 62, 66, 69 to 72, 74 to 79 | IMP-3, 8, 9, 13, 19 to 22, 24, 25, 27,<br>28, 30, 31, 33, 37, 40, 42 |
| | OXA-162, 199, 244, 245, 252, 370, 484,<br>505, 514, 515, 519, 546, 547, 566 | OXA-162, 163, 204, 232, 244, 245,<br>247 |
| | VIM-3 to 6, 8, 9, 11, 12, 14 to 18, 20, 23 to<br>46, 48 to 50, 52 to 55, 57, 59, 60 | VIM 5 to 9, 11 to 18, 20, 23 to 38 |

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1 Note: The variants listed reflect the respective labeling of each device and the analytical studies and in silico analyses conducted at the time of 510(k) clearance.

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The GenePOC™ Carba 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 GenePOC™ Carba assay and the predicate device do not raise new questions of safety and effectiveness.

### L. STANDARDS/GUIDANCE DOCUMENTS REFERENCED

- CLSI Guideline EP25-A, Evaluation of Stability of In Vitro Diagnostic Reagents; . Approved Guideline, 2009.
- . CLSI EP28-A3c, Guideline Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline, 2008.
- CLSI M02, Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved . Guideline, 13th edition, 2018.
- CLSI M100, Performance Standards for Antimicrobial Susceptibility Testing; Approved . Guideline, 28th edition, 2018.

#### M. TEST PRINICIPLE

The GenePOC™ Carba assay is a single-use test for the qualitative detection and differentiation of the blake, blaNDM, blavin, blaoxA-48-ike, and blaIMP gene sequences in carbapenem-non-susceptible pure colonies of Enterobacteriaceae, Acinetobacter baumannii, or Pseudomonas aeruginosa grown on blood agar or MacConkey agar that utilizes an automated sample preparation and real-time polymerase chain reaction (PCR) technology with fluorogenic detection of the amplified DNA. The GenePOC™ Carba assay utilizes the GenePOC™ Carba microfluidic cartridge (PIE) for the simultaneous detection of the blaxer, bland, blaym, blaoxa-48-like, and blamp DNA and the internal process control (PrC) DNA (to verify sample processing, amplification, and the absence of reaction inhibitors).

Well-characterized Enterobacteriaceae, Acinetobacter baumannii, or Pseudomonas aeruginosa, carbapenem-non-susceptible strain is streaked for isolation on a blood agar plate (BAP) or a MacConkey agar plate with a 10-ug meropenem disc on the first quadrant. The plate is then incubated for 18-24 hours at 35°C ± 2°C under aerobic conditions. A standardized 0.5 McFarland (McF) suspension is prepared in saline solution by collecting isolated colonies selected from the incubated agar plate with a sterile swab. Fifteen (15) uL of the 0.5 McF suspension are transferred into the Sample Buffer Tube (SBT) containing 1 mL of Sample Buffer (SB). After a 15-second vortex step at maximal speed, a volume of SB lying between the two marks of the DTT is sampled from the SBT and transferred into a GenePOC™ Carba PIE to perform the assay. The loaded GenePOC™ Carba PIE is placed into the revogene™ for further sample processing. No operator intervention is necessary once the sample is loaded onto the revogene™.

Each Carba PIE is a completely integrated and self-contained device. Each sample is sequentially transferred by centrifugation from one microfluidic chamber to the next and all reagents specific for the PCR reaction are incorporated and dried within the PCR wells. The stepwise process includes sample homogenization, lysis of cells, and sample dilution followed by the subsequent real-time PCR steps. An internal PrC is contained in the homogenization chamber and is therefore present in every test to verify critical steps of the analytical process

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(including sample lysis, dilution and nucleic acid amplification and detection) for the presence of potential inhibitory substances as well as system or reagent failures. The amplified products are detected in real time using target-specific TagMan® chemistry-based probes. The results are interpolated by the system from measured fluorescent signals and embedded calculation algorithms. Results may be viewed, printed, transferred, and/or stored by the user.

### N. PERFORMANCE CHARACTERISTICS

#### 1. Analytical Performance

- Reproducibility/Precision a.
The Reproducibility and Precision study was performed by testing a total of ten (10) positive bacterial carbapenem-non-susceptible strains, each one harboring resistance gene targeted by the GenePOC™ Carba assay (n=2 strains per resistance gene, i.e. blakec, blaNDM, blaOXA-48-like, and blamp) and one (1) negative bacterial carbapenem-non-susceptible strain that does not carry any of the resistance genes targeted by the assay from standardized 0.5 McF suspensions.

The Between-Laboratory Reproducibility study was performed by two (2) operators at three (3) sites with one (1) GenePOC™ Carba assay kit lot over a total of five (5) days (consecutive or not) per panel member tested. Two (2) runs were performed by each operator on each day. On each day of testing, four (4) panel members of each positive strain were tested on each site and by each operator for a total of 120 replicates per strain (5 days of testing x 4 panel members per strain x 3 sites x 2 operators = 120 replicates per strain). Eight (8) negative panel members were also tested on each site and by each operator, on each respective day of testing for a total of 240 replicates (5 days of testing x 8 panel members x 3 sites x 2 operators = 240 replicates).

To assess the Between-Lot Reproducibility, testing was pursued at one (1) site with two (2) additional kit lots for a total of 15 days of testing (five (5) days per kit lot, consecutive or not) per panel member tested for each kit lot. Two (2) runs per kit lot were performed by each operator on each day. On each day of testing, four (4) panel members of each positive strain were tested by each operator for a total of 120 replicates per strain (5 days of testing x 4 panel members per strain x 3 kit lots x 2 operators = 120 replicates per strain). Eight (8) negative panel members were also tested with each kit lot and by each operator, on each respective day of testing for a total of 240 replicates (5 days of testing x 8 panel members x 3 kit lots x 2 operators = 240 replicates).

The Within-Laboratory Precision for each panel member was calculated based on one (1) GenePOC™ Carba assay kit lot (kit lot 1) that was tested by two (2) operators at site 1 over a total of five (5) days (consecutive or not). A total of 40 replicates for each of the ten (10) positive bacterial carbapenem-non-susceptible strains, each one harboring one (1) resistance gene targeted by the GenePOC Carba assay (n=2 strains per resistance gene), were considered for the analysis (5 days of test…