Great Basin Staph ID/R Blood Culture Panel

K152470 · Great Basin Scientific, Inc. · PAM · Mar 25, 2016 · Microbiology

Device Facts

• Record ID: K152470
• Device Name: Great Basin Staph ID/R Blood Culture Panel
• Applicant: Great Basin Scientific, Inc.
• Product Code: PAM · Microbiology
• Decision Date: Mar 25, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3365
• Device Class: Class 2

Indications for Use

The Great Basin Staph ID/R Blood Culture Panel is a qualitative, multiplex, nucleic acid-based in vitro diagnostic assay intended for the simultaneous identification of nucleic acid from Staphylococcus aureus, Staphylococcus lugdunensis and various Staphylococcus species to the genus level and the detection of the mecA gene for methicillin resistance directly from patient positive blood culture specimens. The test utilizes automated hot-start enabled polymerase chain reaction (PCR) for the amplification of specific DNA targets detected by hybridization probes immobilized on a silicon chip surface. The assay is performed directly on positive blood culture specimens identified as positive by continuous monitoring blood culture system that demonstrates the presence of organisms as determined by Gram stain to contain gram-positive cocci in clusters (GPCC) or gram-positive cocci in singles (GPC). The test may be performed using blood culture bottles. The Staph ID/R Blood Culture Panel identifies Staphylococcus aureus (SA), and Staphylococcus lugdunensis, and detects other Staphylococcus species without identification to species level. The Portrait Staph ID/R Blood Culture Panel is indicated for use in conjunction with other clinical or laboratory findings to aid in the diagnosis of bacterial bloodstream infections; however, it is not used to monitor these infections. Sub-culturing positive blood cultures is necessary to recover viable organisms for further identification, susceptibility testing, or epidemiological typing to identify organisms in the blood culture that are not detected by the Great Basin Staph ID/R Blood Culture Panel. If detected, mecA may or may not be associated with Staphylococcus spp. detected or the agent responsible for the disease. Negative results for mecA antimicrobial resistance gene assays do not always indicate susceptibility, as other mechanisms of resistance to methicillin exist.

Device Story

Device uses automated hot-start PCR to amplify DNA from positive blood culture bottles; targets include tuf gene (Staphylococcus genus), nuc gene (S. aureus), and mecA gene (methicillin resistance). Amplified DNA hybridizes to probes on a silicon chip; detection via HRP-conjugated antibody and TMB substrate. Portrait Optical Reader detects colored precipitate. System includes Portrait Analyzer, single-use test cartridges, and data analysis software. Used in clinical labs; provides results in ~110 minutes. Output aids clinicians in diagnosing bacterial bloodstream infections; requires sub-culturing for further identification/susceptibility testing.

Clinical Evidence

Prospective clinical study (n=831) compared device to reference methods. S. aureus PPA 98.6% (96.0-99.5%), NPA 99.5% (98.4-99.8%). S. lugdunensis PPA 100% (43.9-100%), NPA 99.9% (99.3-99.9%). mecA detection with S. aureus PPA 94.4% (86.6-97.8%), NPA 98.8% (97.7-99.4%). Simulated/frozen samples included. Bench testing confirmed LoD, inclusivity, exclusivity, and interference resistance.

Technological Characteristics

Multiplex PCR and silicon chip-based hybridization. Targets: tuf gene, nuc gene, mecA gene. Fully automated system (PA500 Portrait Analyzer). Single-use fluidic test cartridges. Optical detection of HRP-TMB precipitate. Standalone system with integrated data analysis software.

Indications for Use

Indicated for patients with positive blood culture specimens (Gram stain GPCC or GPC) to aid in diagnosis of bacterial bloodstream infections. Identifies S. aureus, S. lugdunensis, and Staphylococcus spp. (genus level), and detects mecA gene for methicillin resistance.

Regulatory Classification

Identification

A multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures is a qualitative in vitro device intended to simultaneously detect and identify microorganism nucleic acids from blood cultures that test positive by Gram stain or other microbiological stains. The device detects specific nucleic acid sequences for microorganism identification as well as for antimicrobial resistance. This device aids in the diagnosis of bloodstream infections when used in conjunction with other clinical and laboratory findings. However, the device does not replace traditional methods for culture and susceptibility testing.

Special Controls

In combination with the general controls of the FD&C Act, the Verigene® Gram Positive Blood Culture Nucleic Acid Test is subject to the following special controls: The special controls for the BC-GP Assay are contained in the guideline document entitled "Class II Special Controls Guideline: Multiplex Nucleic Acid Assay for Identification of Microorganisms and Resistance Markers from Positive Blood Cultures."

*Classification.* Class II (special controls). The special control for this device is FDA's guideline document entitled “Class II Special Controls Guideline: Multiplex Nucleic Acid Assay for Identification of Microorganisms and Resistance Markers from Positive Blood Cultures.” For availability of the guideline document, see § 866.1(e).

Predicate Devices

• Verigene Gram Positive Blood Culture Nucleic Acid Test (BC-GP) (K113450)

Submission Summary (Full Text)

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

April 26, 2016

GREAT BASIN SCIENTIFIC, INC. CHUCK OWEN DIRECTOR, REGULATORY AFFAIRS & QUALITY ASSURANCE 2441 S. 3850 WEST SALT LAKE CITY, UT 84120

Re: K152470 Trade/Device Name: Great Basin Staph ID/R Blood Culture Panel Regulation Number: 21 CFR 866.3365 Regulation Name: Multiplex Nucleic Acid Assay for Identification of Microorganisms and Resistance Markers from Positive Blood Cultures Regulatory Class: II Product Code: PAM, OOI Dated: February 22, 2016 Received: February 25, 2016

Dear Mr. Owen:

This letter corrects our substantially equivalent letter of March 25, 2016.

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 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

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Page 2 - Mr. Owen

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR 801 and 809); medical device 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.

If you desire specific advice for your device on our labeling regulation (21 CFR 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 vours.

# Kristian M. Roth -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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## Indications for Use

510(k) Number (if known) K152470

Device Name Great Basin Staph ID/R Blood Culture Panel

#### Indications for Use (Describe)

The Great Basin Staph ID/R Blood Culture Panel is a qualitative, multiplex, nucleic acid-based in vitro diagnostic assay intended for the simultaneous identification of nucleic acid from Staphylococcus lugdumensis and various Staphylococcus species to the genus level and the detection of the mecA gene for methicillin resistance directly from patient positive blood culture specimens. The test utilizes automated hot-start enabled polymerase chain reaction (PCR) for the amplification of specific DNA targets detected by hybridization probes immobilized on a silicon chip surface. The assay is performed directly on positive blood culture specimens identified as positive by continuous monitoring blood culture system that demonstrates the presence of organisms as determined by Gram stain to contain gram-positive cocci in clusters (GPCC) or gram-positive cocci in singles (GPC). The test may be performed using blood culture bottles. The Staph ID/R Blood Culture Panel identifies Staphylococcus aureus (SA), and Staphylococcus lugdunensis, and detects other Staphylococcus species without identification to species level.

The Portrait Staph ID/R Blood Culture Panel is indicated for use in conjunction with other clinical or laboratory findings to aid in the diagnosis of bacterial bloodstream infections; however, it is not used to monitor these infections. Subculturing positive blood cultures is necessary to recover viable organisms for further identification, susceptibility testing, or epidemiological typing to identify organisms in the blood culture that are not detected by the Great Basin Staph ID/R Blood Culture Panel. If detected, mecA may or may not be associated with Staphylococcus spp. detected or the agent responsible for the disease. Negative results for mecA antimicrobial resistance gene assays do not always indicate susceptibility, as other mechanisms of resistance to methicillin exist.

| Type of Use (Select one or both, as applicable) |
|------------------------------------------------------------------------------------|
| <span style="font-size:12px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) |
| <span style="font-size:12px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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Image /page/3/Picture/1 description: The image shows the logo for Great Basin Scientific. The logo consists of a series of blue oval shapes arranged in a staircase pattern above the words "GREAT BASIN" in gold, with the word "SCIENTIFIC" in smaller gold letters below. The logo is simple and modern, and the colors are eye-catching.

March 23, 2016

## 510(k) Summary: Great Basin Staph ID/R Blood Culture Panel

## A. Submitted by:

Great Basin Corporation 2441 South 3850 West Salt Lake City, Utah 84120 Phone: [phone] Fax: [phone]

## Contact Information

Chuck Owen, Director of Requlatory Affairs Phone: [phone] Fax: Email: [e-mail]

### B. Name of Device

| Proprietary Name: | Great Basin Staph ID/R Blood Culture Panel |
|-------------------|--------------------------------------------|
|-------------------|--------------------------------------------|

| Common or Usual Names: | Staph ID/R Blood Culture Panel<br>Staph Assay<br>SIDR |
|------------------------|-------------------------------------------------------|
|------------------------|-------------------------------------------------------|

## C. Regulatory Information:

| a. Regulation Section: | 21 CFR 866.3365 – Multiplex Nucleic Acid Assay<br>for Identification of Microorganisms and Resistance<br>Markers from Positive Blood Cultures<br>21 CFR 862.2570 – Instrumentation for clinical<br>multiplex test systems |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| b. Classification: | Class II (Staph ID/R Blood Culture Panel; non-exempt)<br>Class II (PA500 Portrait Analyzer System) |
| c. Classification panel: | Microbiology Devices, OIVD (83) Microbiology |
| d. Product Code: | PAM (Gram-positive bacteria and their resistance markers)<br>OOI (Real-time nucleic acid amplification system) |

### D. Intended use(s)/Indications for Use:

The Great Basin Staph ID/R Blood Culture Panel is a qualitative, multiplex, nucleic acid-based in vitro diagnostic assay intended for the simultaneous identification of nucleic acid from Staphylococcus aureus, Staphylococcus lugdunensis and various Staphylococcus species to the genus level and the detection of the mecA gene for methicillin resistance directly from patient positive blood culture specimens. The test utilizes automated hot-start enabled polymerase chain reaction (PCR) for the

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Image /page/4/Picture/1 description: The image shows the logo for Great Basin Scientific. The logo features a series of blue oval shapes arranged in a step-like pattern above the words "GREAT BASIN" in a gold, sans-serif font. Below "GREAT BASIN" is the word "SCIENTIFIC" in a smaller, similar font.

amplification of specific DNA targets detected by hybridization probes immobilized on a silicon chip surface. The assay is performed directly on positive blood culture specimens identified as positive by continuous monitoring blood culture system that demonstrates the presence of organisms as determined by Gram stain to contain gram-positive cocci in clusters (GPCC) or gram-positive cocci in singles (GPC). The test may be performed using blood culture bottles. The Staph ID/R Blood Culture Panel identifies Staphylococcus aureus (SA), and Staphylococcus lugdunensis, and detects other Staphylococcus species without identification to species level.

The Portrait Staph ID/R Blood Culture Panel is indicated for use in conjunction with other clinical or laboratory findings to aid in the diagnosis of bacterial bloodstream infections; however, it is not used to monitor these infections. Sub-culturing positive blood cultures is necessary to recover viable organisms for further identification, susceptibility testing, or epidemiological typing to identify organisms in the blood culture that are not detected by the Great Basin Staph ID/R Blood Culture Panel. If detected, mecA may or may not be associated with Staphylococcus spp. detected or the agent responsible for the disease. Negative results for mecA antimicrobial resistance gene assays do not always indicate susceptibility, as other mechanisms of resistance to methicillin exist.

### E. Device Description:

#### Test Principle:

The Great Basin Staph ID/R Blood Panel on the PA500 Portrait™ Analyzer System utilizes automated hot-start enabled polymerase chain reaction (PCR) amplification technology to amplify specific nucleic acid sequences that are detected using species specific Staphylococcal DNA hybridization probes immobilized on a modified silicon chip surface.

Target genomic DNA is extracted from microbial cells and diluted to reduce potential inhibitors of the PCR reaction. During the PCR process, double-stranded DNA is separated and target nucleic acid sequences are amplified by thermal cycling. Biotin-labeled primers direct amplification of specific nucleic acid sequences within a variable region of the tuf gene for identification of coagulase-neqative Staphylococcus species, within conserved region of the thermonuclease (nuc) gene for specific identification of Staphylococcus aureus, and the mecA gene for detecting oxacillin/methicillin resistance. Following the PCR process, biotin-labeled, amplified target DNA sequences are hybridized to an array of probes immobilized on the silicon chip surface, then incubated with antibody conjugated to the horseradish peroxidase enzyme (HRP). The unbound conjugate is removed by washing and tetramethylbenzidine (TMB) is added to produce a colored precipitate at the location of the probe/target sequence complex. The resulting signal is detected by the automated Portrait Optical Reader within the Portrait System.

#### Test Device:

The Great Basin PA500 Portrait Analyzer System is a fully automated system that includes the Portrait Analyzer, single-use Staph ID/R Blood Culture Panel Test Cartridges, and the Portrait data analysis software. The PA500 Portrait Analyzer System is designed to perform automated sample preparation, PCR, and optical chip-based detection with integrated data analysis in approximately 110 minutes.

### F. Substantial Equivalence Information:

- a. Predicate Device: Verigene Gram Positive Blood Culture Nucleic Acid Test (BC-GP)
- b. Predicate 510(k) number: K113450

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Image /page/5/Picture/0 description: The image contains the logo for Great Basin Scientific. The logo features a series of blue shapes resembling steps or a staircase above the words "GREAT BASIN" in gold lettering. Below "GREAT BASIN" is the word "SCIENTIFIC" in a smaller font, also in gold.

## c. Comparison with Predicate

| Item | Staph ID/R Blood Culture Panel | Predicate (K113450) |
|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Great Basin Scientific, Inc. | Nanosphere, Inc. |
| Trade Name | Portrait™ Staph ID/R Blood Culture Panel | Verigene Gram Positive Blood Culture Nucleic Acid Test (BC-GP) |
| 510(k) Number | K152470 | K113450 |
| | Similarities | |
| Classification | Class II | same |
| Intended<br>Use/Indications<br>for Use | The Great Basin Staph ID/R Blood Culture Panel is a qualitative, multiplex,<br>nucleic acid-based in vitro diagnostic assay intended for the simultaneous<br>identification of nucleic acid from Staphylococcus aureus, Staphylococcus<br>lugdunensis and various Staphylococcus species to the genus level and the<br>detection of the mecA gene for methicillin resistance directly from patient<br>positive blood culture specimens. The test utilizes automated hot-start<br>enabled polymerase chain reaction (PCR) for the amplification of specific<br>DNA targets detected by hybridization probes immobilized on a silicon chip<br>surface. The assay is performed directly on positive blood culture specimens<br>identified as positive by continuous monitoring blood culture system that<br>demonstrates the presence of organisms as determined by Gram stain to<br>contain gram-positive cocci in clusters (GPCC) or gram-positive cocci in<br>singles (GPC). The test may be performed using blood culture bottles. The<br>Staph ID/R Blood Culture Panel identifies Staphylococcus aureus (SA), and<br>Staphylococcus lugdunensis, and detects other Staphylococcus species<br>without identification to species level. The Staph ID/R Blood Culture Panel is<br>indicated for use in conjunction with other clinical or laboratory findings to<br>aid in the diagnosis of bacterial bloodstream infections; however, it is not<br>used to monitor these infections. Sub-culturing positive blood cultures is<br>necessary to recover viable organisms for further identification, susceptibility<br>testing, or epidemiological typing to identify organisms in the blood culture<br>that are not detected by the Great Basin Staph ID/R Blood Culture Panel. If<br>detected, mecA may or may not be associated with Staphylococcus spp.<br>detected or the agent responsible for the disease. Negative results for mecA<br>antimicrobial resistance gene assays do not always indicate susceptibility, as<br>other mechanisms of resistance to methicillin exist. | The Verigene® Gram Positive Blood Culture Nucleic Acid Test (BC-GP)<br>performed using the sample-to-result Verigene System is a qualitative,<br>multiplexed <i>in vitro</i> diagnostic test for the simultaneous detection and<br>identification of potentially pathogenic gram-positive bacteria which may<br>cause bloodstream infection (BSI). BC-GP is indicated for use in conjunction<br>with other clinical and laboratory findings, such as culture, to aid in the<br>diagnosis of bacterial bloodstream infections; however, it is not used to<br>monitor bloodstream infections. BC-Gp detects the following bacterial<br>genera and species: <i>Staphylococcus</i> spp., <i>Staphylococcus aureus</i> ,<br><i>Staphylococcus epidermidis</i> , and <i>Staphylococcus lugdunensis</i> , <i>Streptococcus</i><br>spp., <i>Streptococcus pneumonia</i> , <i>Streptococcus pyogenes</i> , <i>Streptococcus</i><br><i>agalactiae</i> , <i>Streptococcus anginosus</i> group, <i>Entercoccus faecalis</i> ,<br><i>Enterococcus faecium</i> , <i>Listeria</i> spp. In addition, BC-GP detects the <i>mecA</i><br>resistance marker, and the <i>vanA</i> and <i>vanB</i> resistance markers, inferring<br>vanA/vanB mediated vancomycin resistance to either <i>E. faecalis</i> or <i>E.</i><br><i>faecium</i> , or the <i>mecA</i> -mediated methicillin resistance to either <i>S. aureus</i> or<br><i>S. epidermidis</i> . BC-GP is indicated for use in conjunction with other clinical<br>or laboratory findings to aid in the diagnosis of bacterial bloodstream<br>infections; however, it is not used to monitor these infections. Sub-culturing<br>of positive blood cultures is necessary to recover organisms for susceptibility<br>testing, identification of organisms not detected by BC-GP, differentiation of<br>mixed growth, association of antimicrobial marker genes to a specific<br>organism, or for epidemiological testing. |
| Qualitative/<br>Quantitative | Qualitative | same |
| Single-Use Test<br>Cartridge | Disposable, single-use, self-contained fluidic test cartridge | same |
| Automated | Yes | same |
| Test Principle | Multiplex nucleic acid array-based detection | same |
| Sample Types | Direct blood culture positive by Gram stain for GPCC or GPC | same |
| Organism and<br>Resistance<br>Marker Detection | <i>S. aureus</i> , <i>S. lugdunensis</i> , <i>Staphylococcus</i> spp., <i>mecA</i> | <i>S. aureus</i> , <i>S. lugdunensis</i> , <i>S. epidermidis</i> , <i>Staphylococcus</i> spp., <i>mecA</i> |
| Controls | One Internal Processing Control (whole organism complete assay<br>control) | Two Internal Processing Controls (whole organism complete assay<br>control and single-stranded DNA Hybridization control) |
| Calibration | Not required | same |
| | Differences…