Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a PCR-based diagnostic assay with automated sample preparation and optical detection. There is no mention of AI or ML in the device description, intended use, or performance studies. The data analysis is integrated but not described as using AI/ML.

Therapeutic

No.
It is an in vitro diagnostic assay used for the identification of specific nucleic acids from Staphylococcus species and the detection of the mecA gene for methicillin resistance, which aids in the diagnosis of bacterial bloodstream infections. It does not directly treat or prevent a disease.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "intended for the simultaneous identification of nucleic acid from Staphylococcus lugdumensis and various Staphylococcus species... and the detection of the mecA gene for methicillin resistance directly from patient positive blood culture specimens." It further clarifies that the panel is "indicated for use in conjunction with other clinical or laboratory findings to aid in the diagnosis of bacterial bloodstream infections." These statements clearly define the device's role in aiding diagnosis, which is the core function of a diagnostic device.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the system includes a "Portrait Analyzer" and "single-use Staph ID/R Blood Culture Panel Test Cartridges," which are hardware components. The software is part of a larger system that includes physical hardware for sample preparation, PCR, and detection.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

The "Intended Use / Indications for Use" section explicitly states: "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...".

This statement directly identifies the device as an in vitro diagnostic assay.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 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.

Product codes

PAM, OOI

Device Description

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.

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

Not Found

Intended User / Care Setting

Not Found

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

The analytical performance was assessed using a variety of studies including Analytical Sensitivity (Limit of Detection), Analytical Reactivity (Inclusivity), Analytical Specificity (Exclusivity), Microbial Interference (Off-Panel and Staphylococcus), Interfering Substances (Chemical), Carry-over/Cross-Contamination, Reproducibility, and Evaluation of Blood Culture Bottle Types.

Analytical Sensitivity (LoD): The LoD was established using 22 different Staphylococcal strains (6 S. aureus, 6 S. epidermidis, 3 S. lugdunensis, and 7 other Staphylococcus species, some with and without mecA). Bacterial stocks were incubated in Tryptic Soy Broth (TSB), measured by optical density, serially diluted, and spiked into BACTEC Plus Aerobic/F blood bottles containing negative blood. Spiked bottles were incubated until alarm positivity in a BACTEC Blood Culture System, then Gram stained, diluted, and plated for colony counting to enumerate actual CFU/mL. A minimum of 20 replicates were tested for each strain.

Analytical Reactivity (Inclusivity): Tested against an additional 48 well-characterized S. aureus strains (representing USA100-1200 and SCCmecA I-VI, XI types) and 104 untyped strains (S. aureus, S. epidermidis, S. lugdunensis, and other Staphylococcus species). A "Challenge Panel" of 8 S. aureus strains (SCCmecA subtypes I-V, 1 mecC strain, 4 Borderline Oxacillin Resistant S. aureus (BORSA), 4 Empty Cassette S. aureus variants) and multiple S. epidermidis and S. lugdunensis strains were also tested. Oxacillin MIC was determined for the challenge panel using BD Phoenix ID.

Analytical Specificity (Exclusivity): Assessed with 116 off-panel microflora (bacterial, yeast, mycoplasma strains). BACTEC Plus Aerobic/F or Anaerobic/F media containing negative blood were inoculated, incubated until alarm positivity, and further incubated for additional time to obtain a target microorganism bottle load ≥10^8 CFU/mL. Gram stain, dilution, and plating confirmed concentrations. Genomic DNA was used for two organisms (≥10^8 copies/mL). A minimum of two replicates were tested for each.

Microbial Interference (Off-Panel and Staphylococcus):

Off-Panel: Evaluated detection of low-level Staphylococcus species in presence of 14 "off-panel" microorganisms (Gram Positive, Gram Negative, Yeast, skin contaminants). Bottles were inoculated with competing microorganisms, grown to high concentrations (>10^8 CFU/mL), and then combined with Staphylococcus TSB cultures at approximately 1-2.5x10^6 CFU/mL. Assessed 5 different Staphylococcus strains.
Staphylococcus: Evaluated detection of low-level Staphylococcus species in presence of 12 other Staphylococcus species. Bacteria were grown to high concentrations (>10^8 CFU/mL) and combined with low-level Staphylococcus TSB cultures (approximately 1-2.5x10^6 CFU/mL). Assessed 5 different Staphylococcus strains.

Interfering Substances (Chemical Interference): Evaluated interference by 16 different substances spiked into BACTEC Plus Aerobic/F or Standard Aerobic/F media containing negative blood. Target Staphylococcus cells (10 ATCC strains) at 2-3X LoD (1-2.5x10^6 CFU/mL) and an off-panel E. faecalis strain were combined with substances. A minimum of two replicate assays were performed for each Staphylococcus strain with each substance.

Carry-over/Cross-Contamination: Assessed by alternatively testing high titer S. aureus, mecA+ ATCC strain BAA-1682 (>10^7 CFU/mL) and off-target negative E. faecalis ATCC strain 29212 (>10^6 CFU/mL) on multiple Portrait Analyzers.

Reproducibility: A multicenter, blinded study at three sites, with two operators per site, using 5 different cartridge lots and 89 different Portrait Analyzers. A panel of seven simulated blood culture specimens, each spiked with a single organism, was used. Half of the replicates for Staphylococcus positive samples were at a low level (time of positivity) and half at a high concentration (after 8 hours of positivity). The E. faecalis (Staph ID/R negative) concentration was "high." Samples were tested on 12 different days over 10 weeks, for a total of 90 replicates per analyte per concentration.

Evaluation of Blood Culture Bottle Types: Thirteen unique bottle types were tested with Staphylococcus isolates or E. faecalis (negative) at bottle ring load levels (2x10^6-1x10^8 CFU/mL). Bottles contained the highest recommended volume of negative blood and were pre-incubated 18 hours. Three bottles of each type were used for each strain, and samples were tested three times in the Staph ID/R Blood Culture Panel for a total of 9 runs per combination.

Clinical Studies: Specimens collected prospectively at three geographically diverse U.S. sites. Blood culture specimens from patients were incubated on BACTEC continuous monitoring blood culture system. Bottles flagged positive and confirmed by Gram stain to contain gram-positive cocci were tested with the Staph ID/R Blood Culture Panel. A total of 831 clinical specimens met inclusion criteria. Additionally, 102 'Low Prevalence' contrived/simulated blood culture specimens were prepared by spiking blood culture bottles with bacterial suspensions, grown to positivity, Gram stained, and then tested.

Summary of Performance Studies

Analytical Sensitivity (LoD):
- Study Type: Analytical study, in vitro.
- Sample Size: Minimum of 20 replicates for 22 different strains (6 S. aureus, 6 S. epidermidis, 3 S. lugdunensis, 7 other Staphylococcus species, with and without mecA).
- Key Results:
  - S. aureus ± mecA: 3.5-8.2x10^5 CFU/mL.
  - S. epidermidis ± mecA: 2.2-7.1x10^5 CFU/mL.
  - S. lugdunensis without mecA: 2.8-4.7x10^5 CFU/mL.
  - Other Staphylococcus species ± mecA: 1.5-5.3x10^5 CFU/mL.
- Standalone Performance: The tables show the number of correct calls out of total replicates, indicating the ability to detect at specified concentrations. For instance, S. aureus, mecA + BAA-1680 at 3.5E+05 CFU/mL yielded 23/23 correct results.
Analytical Reactivity (Inclusivity):
- Study Type: Analytical study, in vitro.
- Sample Size: 48 well-characterized S. aureus strains, 104 untyped strains (S. aureus, S. epidermidis, S. lugdunensis, other Staphylococcus species), and a "Challenge Panel" of 8 S. aureus strains and multiple S. epidermidis and S. lugdunensis strains.
- Key Results: The Staph ID/R Blood Culture Panel correctly detected all additional Staphylococcus strains (mecA present or absent). The challenge panel results showed expected oxacillin MIC results and correct mecA detection for all strains.
Analytical Specificity (Exclusivity):
- Study Type: Analytical study, in vitro.
- Sample Size: 116 off-panel microflora strains (bacterial, yeast, mycoplasma). A minimum of two replicates per strain.
- Key Results: The vast majority of strains tested 'Staphylococcus NEGATIVE', indicating no cross-reactivity or interference. Exceptions were 27 'invalid' calls and 6 'Staphylococcus POSITIVE' calls, which resolved upon re-testing as 'Staphylococcus NEGATIVE'.
Microbial Interference (Off-Panel and Staphylococcus):
- Study Type: Analytical study, in vitro.
- Sample Size:
  - Off-Panel: Evaluated 5 Staphylococcus strains in presence of 14 "off-panel" microorganisms (at ≥10^8 CFU/mL).
  - Staphylococcus: Evaluated 5 low-level Staphylococcus strains in presence of 12 other Staphylococcus species (at ≥10^8 CFU/mL).
- Key Results:
  - Off-Panel: No interference observed for valid runs at initial concentrations. Some miscalls at low target concentrations were resolved at higher (2-3X LoD) inputs.
  - Staphylococcus: Interference observed for some combinations (e.g., S. aureus with S. epidermidis/S. caprae, S. epidermidis with various Staphylococcus, S. lugdunensis with S. epidermidis/S. hominis) at initial concentrations. All interferences were resolved upon re-testing at higher CFU/mL inputs (2-3X LoD).
Interfering Substances (Chemical Interference):
- Study Type: Analytical study, in vitro.
- Sample Size: 10 Staphylococcus ATCC strains and 1 E. faecalis strain tested with 16 different substances in two different BACTEC media. Minimum of two replicates per strain per substance.
- Key Results: The substances generally did not interfere with detection of strains, resulting in expected positive or negative calls. Some invalid runs were noted but resolved.
Carry-over/Cross-Contamination Study:
- Study Type: Analytical study, in vitro.
- Sample Size: High titer S. aureus, mecA+ ATCC strain BAA-1682 and off-target negative E. faecalis ATCC strain 29212, run in alternating series on multiple Portrait Analyzers.
- Key Results: All calls were in concordance with expected calls, showing no evidence of contamination.
Reproducibility:
- Study Type: Multicenter, blinded study.
- Sample Size: 7 simulated blood culture specimens, 6 operators at 3 sites, 5 cartridge lots, 89 Portrait Analyzers. 90 replicates per analyte per concentration over 12 different days. Total of 642 runs for validity (7 analytes * 90 replicates + additional negative analyte).
- Key Metrics / Performance:
  - Overall valid results: 630/642 (98.1%).
  - Detection of Staphylococcus positivity: 540/540 (100%) for expected positives; 87/90 (96.7%) for expected negatives.
  - Detection of specific Staphylococcus (S. aureus, S. epidermidis, S. lugdunensis, mecA):
    - S. aureus, mecA present (low/high): 90/90 (100%) and 90/90 (100%).
    - S. epidermidis, mecA present (low/high): 90/90 (100%) and 90/90 (100%).
    - S. lugdunensis, mecA absent (low): 88/90 (97.8%). (2 false negatives)
    - S. lugdunensis, mecA absent (high): 90/90 (100%).
    - Negative samples for specific Staphylococcus: Range from 99.1% to 100% agreement.
  - Detection of mecA gene (no organism associated):
    - MecA present: 359/360 (99.7%).
    - MecA absent: 270/270 (100%).
  - MecA for S. aureus (mecA+): 180/180 (100%).
  - MecA for S. epidermidis (mecA+): 179/180 (99.4%). (1 false negative)
  - Ten discrepant results were obtained (e.g., misidentification of Staphylococcus species, false positive/negative mecA, mixed infection calls).
Evaluation of Blood Culture Bottle Types:
- Study Type: Analytical study, in vitro.
- Sample Size: 13 unique bottle types, 7 Staphylococcus ATCC strains, and 1 E. faecalis strain. 9 runs for each strain and bottle type combination.
- Key Results: All potential blood bottle types were compatible, with no false negative results for Staphylococcus detection. A single false positive "S. aureus, mecA Present" was observed for S. aureus, mecA- 11632 in Versa Trek Redox 1 (attributed to contamination). A single false positive "Staphylococcus Positive, Staphylococcus species OTHER than S. aureus or S. lugdunensis, mecA absent" was observed for E. faecalis 29212 in BacT/Alert SN Anaerobic (attributed to contamination). Nine 'Invalid' calls were noted for E. faecalis 29212 across different bottle types, indicating an elevated invalid rate (5-28%) compared to the prospective study.
Prospective Clinical Studies / Performance Data:
- Study Type: Prospective clinical study (for prospective data) combined with contrived/simulated specimens (for low prevalence data).
- Sample Size: 831 prospective clinical specimens; 102 'Low Prevalence' contrived/simulated specimens.
- Key Metrics (PPA, NPA):
  - Detection of Staphylococcus aureus:
    - Prospective: PPA 98.6% (211/214), NPA 99.5% (548/551).
    - Simulated: PPA N/A (0/0), NPA 100.0% (102/102).
    - Overall: PPA 98.6% (211/214), NPA 99.5% (650/653).
  - Detection of Staphylococcus lugdunensis:
    - Prospective: PPA 100.0% (3/3), NPA 99.9% (761/762).
    - Simulated: PPA 100.0% (30/30), NPA 100.0% (72/72).
    - Overall: PPA 100.0% (33/33), NPA 99.9% (833/834).
  - Detection of Staphylococcus species OTHER than S. aureus or S. lugdunensis:
    - Prospective: PPA 98.9% (444/449), NPA 97.2% (307/316).
  - Detection of mecA with Staphylococcus aureus:
    - Prospective: PPA 94.4% (68/72), NPA 98.8% (682/690).
    - Frozen (archived): PPA 100.0% (35/35), NPA 100.0% (34/34).
    - Overall: PPA 96.3% (103/107), NPA 98.9% (716/724).
  - Detection of mecA with Staphylococcus lugdunensis:
    - Prospective: PPA N/A (0/0), NPA 100.0% (762/762).
  - Detection of mecA with Staphylococcus species OTHER than S. aureus or S. lugdunensis:
    - Prospective: PPA 92.7% (243/262), NPA 96.2% (481/500).
- Polymicrobial Specimens: Table 17 lists polymicrobial specimens detected by both Staph ID/R and Reference Method(s), as well as discrepant results for polymicrobial samples. For instance, DNYS031 was a false negative for S. aureus by Staph ID/R but correct for Staph call and mecA.
- Invalid and Abort Rates (Clinical Studies):
  - Initial Invalid rate: 1.39% (11/789). Final: 0.00%.
  - Initial Abort rate: 3.30% (26/789). Final: 0.00%.
  - Initial "No Call" rate (Invalids + Aborts): 4.69% (37/789). Final: 0.00%.

Key Metrics

Refer to "Summary of Performance Studies" section for detailed metrics including PPA, NPA, and concordance rates from reproducibility.

Predicate Device(s)

K113450

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 866.3365 Multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures.

(a)
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.(b)
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).

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)
☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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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: 801-990-1055 Fax: 801-990-1051

Contact Information

Chuck Owen, Director of Requlatory Affairs Phone: 385-215-3313 801-990-1051 Fax: Email: cowen@gbscience.com

B. Name of Device

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

| Common or Usual Names: | Staph ID/R Blood Culture Panel
Staph Assay
SIDR |

------------------------	-------------------------------------------------------

C. Regulatory Information:

| a. Regulation Section: | 21 CFR 866.3365 – Multiplex Nucleic Acid Assay
for Identification of Microorganisms and Resistance
Markers from Positive Blood Cultures
21 CFR 862.2570 – Instrumentation for clinical
multiplex test systems |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| b. Classification: | Class II (Staph ID/R Blood Culture Panel; non-exempt)
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)
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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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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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
Use/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 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.	The Verigene® Gram Positive Blood Culture Nucleic Acid Test (BC-GP)
performed using the sample-to-result Verigene System is a qualitative,
multiplexed in vitro diagnostic test for the simultaneous detection and
identification of potentially pathogenic gram-positive bacteria which may
cause bloodstream infection (BSI). BC-GP is indicated for use in conjunction
with other clinical and laboratory findings, such as culture, to aid in the
diagnosis of bacterial bloodstream infections; however, it is not used to
monitor bloodstream infections. BC-Gp detects the following bacterial
genera and species: Staphylococcus spp., Staphylococcus aureus ,
Staphylococcus epidermidis , and Staphylococcus lugdunensis , Streptococcus
spp., Streptococcus pneumonia , Streptococcus pyogenes , Streptococcus
agalactiae , Streptococcus anginosus group, Entercoccus faecalis ,
Enterococcus faecium , Listeria spp. In addition, BC-GP detects the mecA
resistance marker, and the vanA and vanB resistance markers, inferring
vanA/vanB mediated vancomycin resistance to either E. faecalis or E.
faecium , or the mecA -mediated methicillin resistance to either S. aureus or
S. epidermidis . BC-GP 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
of positive blood cultures is necessary to recover organisms for susceptibility
testing, identification of organisms not detected by BC-GP, differentiation of
mixed growth, association of antimicrobial marker genes to a specific
organism, or for epidemiological testing.
Qualitative/
Quantitative	Qualitative	same
Single-Use Test
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
Resistance
Marker Detection	S. aureus , S. lugdunensis , Staphylococcus spp., mecA	S. aureus , S. lugdunensis , S. epidermidis , Staphylococcus spp., mecA
Controls	One Internal Processing Control (whole organism complete assay
control)	Two Internal Processing Controls (whole organism complete assay
control and single-stranded DNA Hybridization control)
Calibration	Not required	same
	Differences
Intended
Use/Indications
for Use	Identification of S. aureus , S. lugdunensis , detection of other
Staphylococcus spp. Detection of the mecA gene for methicillin
resistance in all Staphylococcus organisms.	Tests for same Staphylococcus targets. Detection of mecA gene for
methicillin reistance in S. aureus and S. epidermidis only. Tests for
additional gram-positive bacteria including Streptococcus spp.,
Streptococcus pneumonia , Streptococcus pyogenes , Streptococcus
agalactiae , Streptococcus anginosus group, Entercoccus faecalis ,
Enterococcus faecium , and Listeria spp. Tests for additional resistance
markers including the vanA and vanB resistance markers, inferring
vanA/vanB mediated vancomycin resistance to either E. faecalis or E.
faecium .
Test Principle/
Technology	Fully automated multiplex PCR and detection by target-specific
capture oligonucleotides immobilized in a macroarray format onto a
chip surface for probe-based end-point.	Fully automated multiplex DNA detection of specific nucleic acid
sequences in a microarray format using target-specific capture and
mediator oligonucleotides for probe-based end-point detection.
Instrument	PA500 Portrait Analyzer	Verigene Reader and Processor SP

6

G. Performance Data - Analytical Studies

a. Analytical Sensitivity

The limit of detection (LoD) of the Staph ID/R Blood Culture Panel to Staphylococcus with or without mecA was assessed and confirmed with twenty-two (22) different strains. For these studies, overnight incubations of each bacterial stock in Tryptic Soy Broth (TSB) were measured by optical density to estimate the inoculum, serially diluted and spiked into a BACTEC Plus Aerobic/F blood bottle containing neqative blood. Spiked bottles were incubated until alarm positivity in a BACTEC Blood Culture System. Alarm positive blood cultures were gram stained, diluted, plated on agar plates and colonies were counted the following day. The enumerated blood culture bottles were diluted to a 1x108-10° targeted sample input CFU/mL range in BACTEC Plus Aerobic/F media containing neqative blood, tested on device and plated on agar plates to enumerate the actual sample input CFU/mL. The estimations of the sample input CFU/mL were revised to reflect the correct CFU/mL by this colony counting method.

The LoDs for six (6) S. aureus strains ± mecA are reported as 3.5-8.2x10° CFU/mL; the LoD for each S. aureus strain is listed in Table 1.

Table 1. Performance of the Staph ID/R Blood Culture Panel on a minimum of 20 replicates of six (6) Staphylococcus aureus strains ± mecA for establishing LoD.

| Species | ATCC # | Sample Input
(CFU/mL) | Correct Staph ID/R Blood
Culture Panel Results |
|-------------------|----------|--------------------------|---------------------------------------------------|
| S. aureus, mecA + | BAA-1680 | 3.5E+05 | 23/23 |
| | BAA-1682 | 4.0E+05 | 20/20 |
| | BAA-1684 | 8.2E+05 | 22/22 |
| S. aureus, mecA- | 25923 | 5.1E+05 | 21/21 |
| | 6538 | 3.9E+05 | 22/22 |
| | 11632 | 6.2E+05 | 20/20* |

*This set of test runs also contained 1 "Invalid" run

The LoDs for six (6) S. epidermidis strains ± mecA are reported as 2.2-7.1x108 CFU/mL; the LoD for each S. epidermidis strain is listed in Table 2.

Table 2. Performance of the Staph ID/R Blood Culture Panel on a minimum of 20 replicates of six (6) Staphylococcus epidermidis strains ± mecA for establishing LoD.

| Species | ATCC # | Sample Input
(CFU/mL) | Correct Staph ID/R Blood
Culture Panel Results |
|-------------------------------|--------|--------------------------|---------------------------------------------------|
| S. epidermidis, mecA + | 35984 | 3.6E+05 | 20/20 |
| S. epidermidis, mecA + | 51625 | 4.0E+05 | 22/22 |
| S. epidermidis, mecA + | 700562 | 4.3E+05 | 27/27 |
| S. epidermidis, mecA + | 700566 | 5.8E+05 | 23/23 |
| S. epidermidis, mecA- | 700583 | 2.2E+05 | 23/23 |
| S. epidermidis, mecA- | 12228 | 7.1E+05 | 22/23 |

Great Basin Scientific, Inc. 2441 S. 3850 W. Salt Lake City, UT 84120 www.gbscience.com phone: 801-990-1055 fax: 801-990-1051

7

Image /page/7/Picture/1 description: The image shows the logo for Great Basin Scientific. The logo features a series of blue ovals arranged in a diagonal line, resembling a staircase. Below the ovals, the words "GREAT BASIN" are written in a gold sans-serif font, with the word "SCIENTIFIC" in a smaller font below it.

The LoDs for three (3) S. lugdunensis strains without mecA are reported as 2.8-4.7x108 CFU/mL; the LoD for each S. lugdunensis strain is listed in Table 3.

Table 3. Performance of the Staph ID/R Blood Culture Panel on a minimum of 20 replicates of three (3) Staphylococcus lugdunensis strains ± mecA for establishing LoD.

| Species | ATCC # | Sample Input
(CFU/mL) | Correct Staph ID/R Blood
Culture Panel Results |
|------------------------------|--------|--------------------------|---------------------------------------------------|
| S. lugdunensis, mecA- | 43809 | 2.8E+05 | 22/23 |
| | 49576 | 4.5E+05 | 23/23 |
| | 7990 | 4.7E+05 | 23/23 |

LoDs for seven (7) Staphylococcus species ± mecA, excluding S. aureus, S. epidermidis, and S. lugdunensis, are reported as 1.5-5.3x10* CFU/mL. The species were selected for inclusion in the LoD studies based on tuf sequence variation from in silico analysis of the target sequence. The LoD for each Staphylococcus strain is listed in Table 4.

Table 4. Performance of the Staph ID/R Blood Culture Panel on a minimum of 20 replicates of seven (7) Staphylococcus strains ± mecA for establishing LoD.

| Species (CFU/mL) | Culture Panel Results |
|------------------- | S. capitis, mecA - | S. haemolyticus, mecA+ | S. hominis, mecA - | S. pasteuri, mecA - | S. sciuri, mecA - | S. simulans, mecA - | S. warneri, mecA - | Staphylococcus species;
ATCC, CCUG, source | Sample Input
(CFU/mL) | Correct Staph ID/R
Blood Culture
Panel Result |
| S. aureus BAA-38 | S. aureus BAA-44 | S. aureus 700698 | S. aureus BAA-41 | S. aureus BAA-1681 | S. aureus BAA-1682 | S. aureus BAA-1761 | S. aureus NRS660 | S. aureus BAA-1720 | S. aureus BAA-1750 | S. aureus BAA-1760 | S. aureus NRS651 | S. aureus BAA-39 | S. aureus 35592 | S. aureus BAA-1680 | S. aureus BAA-1717 | S. aureus NRS643 | S. aureus NRS662 | S. aureus NRS688 | S. aureus NRS716 | S. aureus BAA-1683 | S. aureus BAA-1696 | S. aureus BAA-1707 | S. aureus BAA-1752 | S. aureus BAA-1684 | S. aureus BAA-1689 | S. aureus BAA-1763 | S. aureus NRS685 | S. aureus BAA-1754 | S. aureus BAA-1755 | S. aureus BAA-1758 | S. aureus BAA-1768 | S. aureus NRS692 | S. aureus NRS675 | S. aureus BAA-1747 | S. aureus NRS483 | S. aureus NRS730 | | S. aureus BAA-1764 | S. aureus NRS484 | S. aureus BAA-1766 | S. aureus BAA-2094 | S. aureus BAA-42 | S. aureus (mecC) BAA-2313 | S. aureus BAA-1751 | S. aureus BAA-1771 | S. aureus BAA-1718 | S. aureus BAA-1749 | S. aureus BAA-1765 | S. aureus BAA-40 | S. aureus BAA-1685 | S. aureus BAA-1708 | S. aureus BAA-1721 | S. aureus 6538 | S. aureus 11632 | S. aureus 12600 | S. aureus 13150 | S. aureus 14775 | S. aureus 14776 | S. aureus 14993 | S. aureus 25923 | S. aureus 29213 | S. aureus 29247 | S. aureus 43300 | S. aureus 700699 | S. aureus BORSA MCW1 Ledeboer Lab | 1.9x106 | S. aureus BORSA MCW2 Ledeboer Lab | 3.6x106 | S. aureus BORSA 23737 Kreiswirth Lab | 2.9x106 | S. aureus BORSA 23739 Kreiswirth Lab | 3.4x106 | S. aureus Diekema lab | S. aureus Diekema lab | S. aureus Diekema lab | S. aureus Diekema lab | | S. auricularis 33751 | S. auricularis 33753 | S. capitis | S. capitis | S. caprae 35538 | S. caprae 51548 | S. chromogenes 43764 | S. chohnii subsp. cohnii 29972 | S. chohnii | S. condimenti 4753 | S. carnosus 51365 | S. delphini 49171 | S. epidermidis 12228 | S. epidermidis 35983 | S. epidermidis 35984 | S. epidermidis 51625 | S. epidermidis 700562 | S. epidermidis 700563 | S. epidermidis 700565 | S. epidermidis 700566 | S. epidermidis 700567 | S. epidermidis 700568 | S. epidermidis 700576 | S. epidermidis 700583 | S. equorum 43958 | S. felis 49163 | S. fleuretti BAA-274 | S. gallinarum 33539 | S. gallinarum 49148 | S. haemolyticus BAA-1693 | S. haemolyticus 43253 | S. haemolyticus 29968 | S. haemolyticus 29970 | S. haemolyticus 700564 | S. hominis 25615 | S. hominis 27844 | S. hominis 51624 | S. hominis 700586 | S. hominis | S. intermedius 29663 | S. intermedius 49052 | S. intermedius 51874 | | S. kloosii 43959 | S. lentus 29070 | S. lugdunensis 4436 | S. lugdunensis 7990 | S. lugdunensis 43809 | S. lugdunensis 48413 | S. lugdunensis 49576 | S. lugdunensis 700328 | S. lutrae 700373 | S. massiliensis 7895 | S. muscae 49912 | S. nepalensis 48992 | S. pasteuri 51129 | S. pettenkoferi 36 | S. piscifermentans 51183 | S. pulvereri 33938 | S. pseudintermidus 49444 | S. saccharolyticus 14953 | S. saprophyticus BAA-750 | S. saprophyticus 15305 | S. schleiferi | S. schleiferi | S. sciuri 29061 | S. sciuri 29060 | S. sciuri 700013 | S. sciuri | S. sciuri | S. simulans 27841 | S. simulans 27848 | S. simiae 7213 | S. succinus | S. vitulinus 51162 | S. warneri 10209 | | S. warneri 25614 | S. warneri 27836 | S. warneri 49454 | S. xylosus 35633 | ATCC # | Sample Input
Correct Staph ID/R Blood
-------------------------------------|----------------------------------------|--------------------------|-----------------------------------------------------|
| 35661 | 1.5E+05 | 20/20* |
| BAA-1693 | 3.1E+05 | 19/20 |
| 27844 | 5.3E+05 | 23/23* |
| 51129 | 5.3E+05 | 21/22 |
| 29060 | 4.3E+05 | 21/21** |
| 27848 | 2.0E+05 | 23/23 |
| 27830 | 4.0E+05 | 22/22 |
NRS, Clinical # | SCCmec, PFGE type /
| I, Denmark | 1.0x106 | 2/2 |
| I, Iberian | 9.2x105 | 2/2 |
| II, Japan | 1.1x106 | 2/2 |
| II, USA100 | 5.9x106 | 2/2 |
| II, USA100 | 1.3x106 | 2/2 |
| II, USA100 | 2.7x106 | 2/2 |
| II, USA100 | 1.2x106 | 2/2 |
| II, USA100 | 4.1x106 | 2/2 |
| II, USA200 | 2.3x106 | 2/2 |
| II, USA200 | 9.5x105 | 2/2 |
| II, USA200 | 2.4x106 | 2/2 |
| II, USA200 | 3.1x106 | 2/2 |
| III, Hungary | 6.4x106 | 2/2 |
| III, ST239 | 1.0x106 | 2/2 |
| IV, USA300 | 2.4x106 | 2/2 |
| IV, USA300 | 3.5x106 | 2/2 |
| IV, USA300 | 3.4x106 | 2/2 |
| IV, USA300 | 5.8x106 | 2/2 |
| IV, USA300 | 4.4x106 | 2/2 |
| IV, USA300 | 4.4x106 | 2/2 |
| IV, USA400 | 1.2x106 | 2/2 |
| IV, USA400 | 4.1x106 | 2/2 |
| IV, USA400 | 4.1x106 | 2/2 |
| IV, USA400 | 4.5x106 | 2/2 |
| IV, USA500 | 1.8x106 | 2/2 |
| IV, USA500 | 2.5x106 | 2/2 |
| IV, USA500 | 6.4x106 | 2/2 |
| IV, USA500 | 3.5x106 | 2/2 |
| IV, USA600 | 6.7x106 | 2/2 |
| IV, USA700 | 6.9x106 | 2/2 |
| IV, USA800 | 8.8x105 | 2/2 |
| IV, USA800 | 8.8x105 | 2/2 |
| IV, USA800 | 2.0x106 | 2/2 |
| IV, USA800 | 3.1x106 | 2/2 |
| IV, USA1000 | 1.5x106 | 2/2 |
| IV, USA1000 | 6.2x106 | 2/2 |
| IV, USA1000 | 2.6x106 | 2/2 |
| | | |
| IV, USA1100 | 9.8x105 | 2/2 |
| IV, USA1100 | 4.4x106 | 2/2 |
| V, USA700 | 4.4x106 | 2/2 |
| V, WA-MRSA | 1.0x106 | 2/2 |
| VI, USA800 | 4.2x106 | 2/2 |
| XI, CC130 | 4.0x106 | 2/2 |
| Untyped, USA600 | 4.0x106 | 2/2 |
| Untyped, USA800 | 4.7x106 | 2/2 |
| NA, USA300 | 4.6x106 | 2/2 |
| NA, USA900 | 2.5x106 | 2/2 |
| NA, USA1200 | 1.1x106 | 2/2 |
| Untyped, Lisbon | 6.5x106 | 2/2 |
| Untyped, ATCC | 4.8x106 | 2/2 |
| Untyped, ATCC | 2.4x106 | 2/2 |
| Untyped, UK | 9.0x105 | 2/2 |
| Untyped, ATCC | 3.1x106 | 2/2 |
| Untyped, ATCC | 1.4x106 | 2/2 |
| Untyped, ATCC | 2.1x106 | 2/2 |
| Untyped, ATCC | 9.0x105 | 2/2 |
| Untyped, ATCC | 3.1x106 | 2/2 |
| Untyped, ATCC | 4.1x106 | 2/2 |
| Untyped, ATCC | 2.4x106 | 2/2 |
| Untyped, ATCC | 4.5x106 | 2/2 |
| Untyped, ATCC | 4.0x106 | 2/2 |
| Untyped, ATCC | 3.0x106 | 2/2 |
| Untyped, ATCC | 3.2x106 | 2/2 |
| Untyped, ATCC | 3.6x106 | 2/2 |
| Untyped, Wisconsin,
| 2/2 |
| Untyped, Wisconsin,
| 2/2 |
| Untyped, New Jersey,
| 2/2 |
| Untyped, New Jersey,
| 2/2 |
Empty Mec Cassette 45 | Untyped, Iowa,
| 6.3x105 | 2/2 |
Empty Mec Cassette 46 | Untyped, Iowa,
| 2.7x106 | 2/2 |
Empty Mec Cassette 50 | Untyped, Iowa,
| 3.7x106 | 2/2 |
Empty Mec Cassette 51 | Untyped, Iowa,
| 2.2x106 | 2/2 |
| | | |
| ATCC | 3.2x105 | 2/2 |
| ATCC | 3.2x105 | 2/2 |
subsp. capitis 35661 | ATCC | 7.2x105 | 2/2 |
subsp. ureolyticus 49326 | ATCC | 2.2x106 | 2/2 |
| ATCC | 9.2x105 | 2/2 |
| ATCC | 1.3x106 | 2/2 |
| ATCC | 4.8x106 | 2/2 |
| ATCC | 4.3x106 | 2/2 |
subsp. urealyticus 49328 | ATCC | 9.3x105 | 2/2 |
| ATCC | 1.2x106 | 2/2 |
| ATCC | 4.9x106 | 2/2 |
| ATCC | 1.7x105 | 2/2 |
| ATCC | 1.2x106 | 2/2 |
| ATCC | 1.8x106 | 2/2 |
| ATCC | 4.6x106 | 2/2 |
| ATCC | 1.2x106 | 2/2 |
| ATCC | 2.0x106 | 2/2 |
| ATCC | 2.7x106 | 2/2 |
| ATCC | 1.1x106 | 2/2 |
| ATCC | 6.6x105 | 2/2 |
| ATCC | 3.9x106 | 2/2 |
| ATCC | 9.4x105 | 2/2 |
| ATCC | 8.5x105 | 2/2 |
| ATCC | 3.5x105 | 2/2 |
| ATCC | 4.2x106 | 2/2 |
| ATCC | 1.1x106 | 2/2 |
| ATCC | 1.3x106 | 2/2 |
| ATCC | 2.2x106 | 2/2 |
| ATCC | 2.5x106 | 2/2 |
| ATCC | 3.5x106 | 2/2 |
| ATCC | 1.2x106 | 2/2 |
| ATCC | 4.8x106 | 2/2 |
| ATCC | 3.9x106 | 2/2 |
| ATCC | 3.5x106 | 2/2 |
| ATCC | 3.2x106 | 2/2 |
| ATCC | 1.6x106 | 2/2 |
| ATCC | 3.0x106 | 2/2 |
| ATCC | 2.4x106 | 2/2 |
subsp. novobiosepticus 700237 | ATCC | 2.2x106 | 2/2 |
| ATCC | 1.1x106 | 2/2 |
| ATCC | 1.0x106 | 2/2 |
| | | |
| ATCC | 2.5x10° | 2/2 |
| ATCC | 2.4x10° | 2/2 |
| ATCC | 6.8x105 | 2/2 |
| CCM, Czech | 2.9x10° | 2/2 |
| ATCC, NCTC | 3.0x10° | 2/2 |
| ATCC | 2.0x10° | 2/2 |
| CCUG, Sweden | 4.3×10° | 2/2 |
| ATCC | 8.2x109 | 2/2 |
| ATCC | 3.0x10° | 2/2 |
| ATCC | 8.4×10* | 2/2 |
| ATCC | 1.8×10° | 2/2 |
| ATCC | 1.4x10° | 2/2 |
| ATCC | 3.3x10° | 2/2 |
| ATCC | 5.1x10° | 2/2 |
| Indianapolis, Denys Lab | 2.0x10° | 2/2 |
| ATCC | 2.4x10° | 2/2 |
| ATCC | 1.2×10° | 2/2 |
| ATCC | 1.7×10° | 2/2 |
| ATCC | 7.3x103 | 2/2 |
| ATCC | 2.1x10° | 2/2 |
| ATCC | 1.7×10° | 2/2 |
subsp. coagulans 49545 | ATCC | 1.7×10° | 2/2 |
subsp. schleiferi 43808 | ATCC | 1.3×10° | 2/2 |
| ATCC | 5.5x10- | 2/2 |
| ATCC | 1.1x10° | 2/2 |
| ATCC | 2.9x10° | 2/2 |
subsp. carnaticus 700058 | ATCC | 2.1x10° | 2/2 |
subsp. rodentium 700063 | ATCC | 1.8x106 | 2/2 |
| ATCC | 5.3x105 | 2/2 |
| ATCC | 5.7x108 | 2/2 |
| ATCC | 1.2×10° | 2/2 |
subsp. succinus 700337 | ATCC | 1.6x105 | 2/2 |
| ATCC | 1.1x106 | 2/2 |
| ATCC | 2.4x106 | 2/2 |
| ATCC | 1.1x106 | 2/2 |
| | | |
| ATCC | 4.2x106 | 2/2 |
| ATCC | 1.4×10° | 2/2 |
| ATCC | 1.7×10€ | 2/2 |

*This set of test runs also contained 1 "Invalid" run

**This set of test runs also contained 2 "Invalid" runs

b. Analytical Reactivity (Inclusivity)

The analytical reactivity of the Staph ID/R Blood Culture Panel was tested against an additional 48 well characterized S. aureus strains from ATCC representing USA100-1200 and SCCmecA I-VI, XI types representative of temporal and geographical diversity. In addition, 104 untyped strains, representing S. aureus, S. epidermidis, S. lugdunensis, and other various Staphylococcus species were tested in the Staph ID/R Blood Culture Panel.

The Staph ID/R Blood Culture Panel correctly detected all of the additional Staphylococcus strains, mecA present or absent (Table 5).

8

Table 5. Analytical Reactivity (Inclusivity) Panel. Staphylococcus strains and results for inclusivity by the Staph ID/R Blood Culture Panel.

Great Basin Scientific, Inc. 2441 S. 3850 W. Salt Lake City, UT 84120 www.gbscience.com phone: 801-990-1055 fax: 801-990-1051

9

Image /page/9/Picture/0 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 lettering. Below "GREAT BASIN" is the word "SCIENTIFIC" in a smaller gold font.

Great Basin Scientific, Inc. 2441 S. 3850 W. Salt Lake City, UT 84120 www.gbscience.com phone: 801-990-1055 fax: 801-990-1051

10

Image /page/10/Picture/0 description: The image shows the logo for Great Basin Scientific. The logo features a series of blue oval shapes arranged in a descending staircase pattern above the words "GREAT BASIN" in gold lettering. Below "GREAT BASIN" is the word "SCIENTIFIC" in a smaller, lighter font.

Great Basin Scientific, Inc. 2441 S. 3850 W. Salt Lake City, UT 84120 www.gbscience.com phone: 801-990-1055 fax: 801-990-1051

11

Image /page/11/Picture/0 description: The image shows the logo for Great Basin Scientific. The logo consists of a series of blue dots arranged in a diagonal line, followed by the words "GREAT BASIN" in gold, and the word "SCIENTIFIC" in a smaller font size below it. The logo is simple and modern, and the colors are eye-catching.

Great Basin Scientific, Inc. 2441 S. 3850 W. Salt Lake City, UT 84120 www.gbscience.com phone: 801-990-1055 fax: 801-990-1051

12

Image /page/12/Picture/0 description: The image shows the logo for Great Basin Scientific. The logo consists of a series of blue dots arranged in a stair-step pattern, followed by the words "GREAT BASIN" in gold, and the word "SCIENTIFIC" in a smaller font below it. The logo is simple and modern, and the colors are eye-catching.

In addition to these studies, a subset of eight (8) S. aureus strains representing SCCmecA subtypes I-V, one (1) mecc strain, four (4) Borderline Oxacillin Resistant S. aureus (BORSA), four (4) Empty Cassette S. aureus variants, and multiple S. epidermidis and S. lugdunensis strains were selected to be part of a "Challenge Panel". The challenge panel was tested for oxacillin MIC using BD Phoenix ID. The results from the MIC determination and card results are listed in Table 6.

13

Image /page/13/Picture/1 description: The image contains the logo for Great Basin Scientific. The logo features a series of blue, rounded shapes arranged in a cascading pattern, resembling a series of steps or a stylized mountain range. Below the shapes, the words "GREAT BASIN" are written in a gold, sans-serif font.

Table 6. Analytical Reactivity (Inclusivity) Challenge Panel. Staphylococcus strains tested for oxacillin MIC and for inclusivity by the Staph ID/R Blood Culture Panel.

| Staphylococcus
species | Strain | SCCmec Type | PFGE/Type Strain | Significance | Oxacillin
MIC (µg/mL) | Staph ID/R Blood Culture Panel Result |
|---------------------------|-----------|-------------|------------------|----------------|--------------------------|--------------------------------------------------------------------------------|
| S. aureus | BAA-38 | I | Unknown | MRSA | >2 | S. aureus, mecA Present |
| S. aureus | 700699 | II | Genome sequenced | MRSA | >2 | S. aureus, mecA Present |
| S. aureus | BAA-1682 | II | USA100 | MRSA | >2 | S. aureus, mecA Present |
| S. aureus | BAA-1681 | II | USA100 | MRSA | >2 | S. aureus, mecA Present |
| S. aureus | 33592 | III | ST239 | MRSA | >2 | S. aureus, mecA Present |
| S. aureus | BAA-1680 | IV | USA300 | MRSA | >2 | S. aureus, mecA Present |
| S. aureus | BAA-1684 | IV | USA500 | MRSA | >2 | S. aureus, mecA Present |
| S. aureus | BAA-2094 | V | WA-MRSA | MRSA | >1 | S. aureus, mecA Present |
| S. aureus | BAA-2313 | XI (mecC) | CC130 | mecC MRSA | 2 | S. aureus, mecA Absent |
| S. aureus | 20723.046 | NA | Unknown | Empty Cassette | 0.5 | S. aureus, mecA Absent |
| S. aureus | 20723.051 | NA | Unknown | Empty Cassette | 0.5 | S. aureus, mecA Absent |
| S. aureus | 20723.045 | NA | Unknown | Empty Cassette | ≤0.25 | S. aureus, mecA Absent |
| S. aureus | 20723.050 | NA | Unknown | Empty Cassette | ≤0.25 | S. aureus, mecA Absent |
| S. aureus | 23736 | NA | Unknown | BORSA | >2 | S. aureus, mecA Absent |
| S. aureus | 23739 | NA | Unknown | BORSA | >2 | S. aureus, mecA Absent |
| S. aureus | 23737 | NA | Unknown | BORSA | 1 | S. aureus, mecA Absent |
| S. aureus | MCW1 | NA | Unknown | BORSA | 0.5 | S. aureus, mecA Absent |
| S. aureus | MCW2 | NA | Unknown | BORSA | ≤0.25 | S. aureus, mecA Absent |
| S. aureus | 12600 | NA | serotype 3 | MSSA | 0.5 | S. aureus, mecA Absent |
| S. aureus | 14993 | NA | Unknown | MSSA | 0.5 | S. aureus, mecA Absent |
| S. aureus | 11632 | NA | Unknown | MSSA | ≤0.25 | S. aureus, mecA Absent |
| S. aureus | 6538 | NA | Unknown | MSSA | ≤0.25 | S. aureus, mecA Absent |
| S. aureus | 25923 | NA | Unknown | MSSA | ≤0.25 | S. aureus, mecA Absent |
| S. epidermidis | 35984 | NA | Genome sequenced | MRSE | >1 | Staphylococcus species OTHER than
S. aureus or S. lugdunensis, mecA Present |
| S. epidermidis | 35983 | NA | Unknown | MRSE | >1 | Staphylococcus species OTHER than
S. aureus or S. lugdunensis, mecA Present |
| S. epidermidis | 700562 | NA | Unknown | MRSE | >1 | Staphylococcus species OTHER than
S. aureus or S. lugdunensis, mecA Present |
| S. epidermidis | 700565 | NA | Unknown | MRSE | >1 | Staphylococcus species OTHER than
S. aureus or S. lugdunensis, mecA Present |
| S. epidermidis | 700567 | NA | Unknown | MRSE | >1 | Staphylococcus species OTHER than
S. aureus or S. lugdunensis, mecA Present |
| S. epidermidis | 700566 | NA | Unknown | MRSE | >1 | Staphylococcus species OTHER than
S. aureus or S. lugdunensis, mecA Present |
| S. epidermidis | 700576 | NA | Unknown | MRSE | >1 | Staphylococcus species OTHER than
S. aureus or S. lugdunensis, mecA Present |
| S. epidermidis | 51625 | NA | Unknown | MRSE | 1 | Staphylococcus species OTHER than
S. aureus or S. lugdunensis, mecA Present |
| S. epidermidis | 12228 | NA | Unknown | MSSE | ≤0.25 | Staphylococcus species OTHER than
S. aureus or S. lugdunensis, mecA Absent |
| S. epidermidis | 700583 | NA | Unknown | MSSE | ≤0.25 | Staphylococcus species OTHER than
S. aureus or S. lugdunensis, mecA Absent |
| S. hominis | 700586 | NA | Unknown | MR Staph ssp | >1 | Staphylococcus species OTHER than
S. aureus or S. lugdunensis, mecA Present |
| S. lugdunensis | 49576 | NA | Unknown | MS - Lug | ≤0.25 | S. lugdunensis, mecA Absent |
| S. lugdunensis | 700328 | NA | Unknown | MS - Lug | ≤0.25 | S. lugdunensis, mecA Absent |
| S. lugdunensis | NCTC 7990 | NA | Unknown | MS - Lug | ≤0.25 | S. lugdunensis, mecA Absent |
| S. lugdunensis | 43809 | NA | Unknown | MS - Lug | ≤0.25 | S. lugdunensis, mecA Absent |

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All strains showed expected oxacillin MIC results, including the BORSA strains, which showed a range of oxacillin resistance (0.25-2 µg/mL) as expected for strains resistant by alternative mechanisms other than mecA. In addition, all empty cassette strains, which lack mecA, were sensitive to oxacillin (0.5-0.25 ug/mL). Samples were correctly detected as detected as mecA Present or Absent in the Staph ID/R Blood Culture Panel. The Staph ID/R did not detect mecA for mecC strain BAA-2313, empty cassette and BORSA strains as expected.

c. Analytical Specificity (Exclusivity)

Studies were performed to assess the potential cross-reactivity of the Staph ID/R Blood Culture Panel with 116 off-panel microflora (bacterial, yeast, and mycoplasma strains). BACTEC Plus Aerobic/F or Anaerobic/F media (for anaerobic strains) containing negative blood were inoculated with isolates and incubated in a BACTEC Blood Culture System until alarm positivity. Alarm positive samples were incubated for additional time in the Blood Culture System consistent with specimen stability studies to obtain a target microorganism bottle load ≥10° CFU/mL. The positive alarm bottles were Gram stained, diluted, plated and counted to confirm all organisms were tested at 1x10° CFU/mL or higher. For two (2) organisms, alarm positive bottles samples were substituted with genomic DNA at a final concentration of ≥10° copies/mL. Genomic DNA was spiked into a matrix of negative blood and BACTEC Plus Aerobic/F media.

A minimum of two (2) replicates was tested in the Staph ID/R Blood Culture Panel for each of the bacterial, fungal and mycoplasma strains evaluated and these data are summarized in Table 7.

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Table 7. Analytical Specificity (Exclusivity) Panel. Non-Staphylococcus microorganisms or DNA from micro-organisms tested for exclusivity by the Staph ID/R Blood Culture Panel.

| Exclusivity Species | Strain (ATCC,
CCUG, Clinical) | Sample Input in
CFU/mL or
copies/mL (gDNA) | Correct Staph ID/R
Blood Panel Result |
|------------------------------------------------|----------------------------------|--------------------------------------------------|------------------------------------------|
| Gram Positive Bacteria | | | |
| Actinomyces odontolyticus | 17929 | 1.7x109 | 2/2 (1) |
| Abiotrophia defectiva | 49176 | 1.4x108 | 2/2 |
| Aerococcus urinae | 51268 | 6.1x108 | 2/2 |
| Arcanobacterium haemolyticum | BAA-1784 | 6.0x108 | 10/11 (2) |
| Bacillus cereus | 14579 | 2.4x109 | 2/2 |
| Corynebacterium diphtheriae | 11051 | 1.5x109 | 2/2 |
| Corynebacterium jeikeium | 43734 | 6.0x108 | 2/2 |
| Enterococcus avium | 14025 | 1.4x109 | 2/2 |
| Enterococcus casseliflavus | 700327 | 1.7x109 | 2/2 |
| Enterococcus durans | 6056 | 7.8x108 | 2/2 |
| Enterococcus faecalis | 29212 | 1.7x109 | 2/2 |
| Enterococcus faecalis | 19433 | 1.4x109 | 2/2 |
| Enterococcus faecalis, van A | 1MC | 3.1x108 | 2/2 |
| Enterococcus faecalis, van B | 51575 | 1.5x109 | 2/2 |
| Enterococcus faecium | 19434 | 4.0x108 | 2/2 |
| Enterococcus faecium | 6057 | 8.2x108 | 2/2 |
| Enterococcus faecium, van A | 700221 | 2.6x108 | 2/2 |
| Enterococcus gallinarum | 700425 | 4.1x108 | 2/2 |
| Enterococcus gallinarum | 49573 | 6.4x108 | 2/2 |
| Enterococcus hirae | 8043 | 6.9x108 | 2/2 |
| Enterococcus raffinosus | 49464 | 9.9x108 | 2/2 |
| Gemella morbillorum | 27824 | 1.0x109 | 2/2 |
| Globicatella sanguinis | 51174 | 6.2x108 | 2/2 |
| Kocuria kristinae | BAA-752 | 1.7x109 | 2/2 |
| Kocuria rosea | 186 | 2.5x108 | 2/2 |
| Kytococcus schroeteri (oxacillin resistant) | BAA-2410 | 1.8x108 | 2/2 |
| Lactobacillus acidophilus | 4356 | 4.8x108 | 2/2 |
| Lactococcus lactis | 11454 | 6.9x108 | 2/2 |
| Lactococcus lactis | 40932 | 2.1x109 | 2/2 |
| Leuconostoc mesenteroides subsp. mesenteroides | 8293 | 1.1x109 | 2/2 |
| Leuconostoc mesenteroides subsp. mesenteroides | 19254 | 9.7x108 | 2/2 |
| Leuconostoc pseudomesenteroides | 12291 | 1.7x109 | 2/2 |
| Listeria grayi | 19120 | 1.1x109 | 2/2 |
| Listeria innocua | 33090 | 1.3x108 | 2/2 |
| Listeria ivanovii | 19119 | 1.5x109 | 2/2 |
| Listeria monocytogenes | 15313 | 4.9x108 | 2/2 |
| Listeria seeligeri | 35967 | 1.1x109 | 2/2 |
| Macrococcus caseolyticus | 13548 | 8.3x108 | 12/13 (1,2) |
| Micrococcus luteus | 10240 | 2.5x108 | 2/2 |
| Micrococcus lylae | 27567 | 5.8x108 | 2/2 |
| Mycobacterium avium | 700898 | 1.9x108 (gDNA) | 2/2 |
| Pediococcus damnosus | 29358 | 1.2x109 | 2/2 |
| Pediococcus pentosaceus | 33316 | 2.9x108 | 2/2 |
| Peptostreptococcus anaerobius | 27337 | 2.3x108 | 2/2 |
| Planococcus citreus | 14404 | 9.2x108 | 2/2 |
| Planococcus kocurii | 43650 | 8.7x108 | 2/2 |
| Propionibacterium acnes | 11827 | 2.4x108 | 2/2 |
| Rhodococcus equi | 6939 | 6.8x108 | 2/2 |
| Rothia dentocariosa | BAA-907 | 2.3x108 | 2/2 |
| Rothia mucilaginosa | 49040 | 9.6x108 | 2/2 |
| Streptococcus agalactiae | BAA-611 | 8.7x108 | 4/4 |
| Streptococcus agalactiae | 13813 | 7.6x108 | 2/2 |
| Streptococcus angunosis | NCTC 10713 | 7.0x108 | 2/2 |
| Streptococcus constellatus | 27823 | 1.1x109 | 2/2 |
| Streptococcus dysagalactiae | 43078 | 4.8x108 | 2/2 |
| Streptococcus equi | 9528 | 6.8x108 | 2/2 |
| Streptococcus gallolyticus | 9809 | 1.9x109 | 2/2 |
| Streptococcus gallolyticus | 49475 | 2.3x109 | 2/2 |
| Streptococcus mitis | 6249 | 1.0x108 | 2/2 |
| Streptococcus mutans | 25175 | 4.2x108 | 2/2 |
| Streptococcus mutans | 35668 | 5.1x108 | 12/13 (2,3) |
| Streptococcus parasanguinis | 15909 | 2.2x108 | 2/2 |
| Streptococcus pneumoniae | ARUP | 1.6x108 | 2/2 |
| Streptococcus pyogenes | 49399 | 1.5x108 | 2/2 |
| Streptococcus pyogenes | 12344 | 1.0x108 | 2/2 |
| Streptococcus pyogenes | 4543 | 1.1x109 | 2/2 |
| Streptococcus sanguinis | 10556 | 9.0x108 | 2/2 |
| Streptococcus thoraltensis | 700865 | 1.1x109 | 2/2 |
| Streptococcus uberis | 9927 | 1.3x108 | 2/2 |
| Gram Negative Bacteria | | | |
| Acinetobacter baumannii | 19606 | 9.0x108 | 2/2 |
| Acinetobacter calcoaceticus | 23055 | 6.5x108 | 2/2 |
| Acinetobacter haemolyticus | 19002 | 3.0x108 | 2/2 |
| Acinetobacter Iwoffi | 17925 | 1.4x109 | 2/2 |
| Bacteriodes fragilis | 23745 | 7.6x108 | 2/2 |
| Bordetella pertussis | 9797 | 1.2x109 | 2/2 |
| Burkholderia cepacia | 25416 | 4.4x108 | 2/2 |
| Citrobacter amalonaticus | 25405 | 3.3x108 | 2/2 |
| Citrobacter freundii | 8090 | 1.1x109 | 2/2 |
| Citrobacter koseri | 27156 | 1.0x109 | 2/2 |
| Enterobacter aerogenes | 15038 | 1.1x109 | 2/2 |
| Enterobacter cloacae | 13047 | 1.0x109 | 2/2 |
| Escherichia coli | BAA-199 | 1.5x109 | 2/2 (1) |
| Escherichia coli | 4157 | 1.1x109 | 2/2 |
| Fusobacterium nucleatum | 25586 | 6.7x108 | 2/2 |
| Haemophilus haemolyticus | 33390 | 1.4x109 | 2/2 |
| Hafnia alvei | 13337 | 1.6x109 | 2/2 |
| Klebsiella oxytoca | 13182 | 1.7x109 | 2/2 |
| Klebsiella pneumoniae | 700603 | 2.3x109 | 2/2 |
| Klebsiella pneumoniae | BAA-1705 | 2.2x109 | 2/2 |
| Kluyvera intermedia | 33421 | 4.4x108 | 2/2 (1) |
| Moraxella catarrhalis | 23246 | 2.1x109 | 2/2 (1) |
| Morganella morganii | 25829 | 1.2x109 | 2/2 |
| Neisseria gonorrhoeae | 19424 | 2.3x109 | 2/2 |
| Neisseria meningitidis | 13077 | 1.8x109 | 2/2 (1) |
| Neisseria subflava | 49275 | 3.5x107 | 2/2 (1) |
| Oligella urethralis | 17960 | 3.1x108 | 2/2 |
| Proteus mirabilis | 25933 | 1.3x109 | 11/13 (1,4) |
| Proteus vulgaris | 6896 | 2.8x108 | 2/2 |
| Providencia rettgeri | 9250 | 1.5x108 | 2/2 |
| Providencia rustigianii | 13159 | 7.3x108 | 2/2 |
| Pseudomonas aeruginosa | 10145 | 1.0x109 | 2/2 |
| Pseudomonas putida | 49128 | 1.2x109 | 2/2 |
| Salmonella enterica | 14028 | 2.1x109 | 2/2 |
| Salmonella typhimurium | 13311 | 1.3x109 | 2/2 (1) |
| Serratia liquefaciens | 27592 | 6.0x108 | 14/15 (2,5) |
| Serratia marcescens | 13880 | 4.4x108 | 2/2 |
| Shigella sonnei | 29930 | 7.6x108 | 2/2 |
| Stenotrophomonas maltophilia | 13637 | 1.2x109 | 2/2 |
| Yersinia enterocolitica | 9610 | 1.6x109 | 2/2 |
| Yeast | | | |
| Candida albicans | 18804 | $3.5x10^9$ | 2/2 |
| Candida glabrata | 66032 | $2.2x10^9$ | 2/2 |
| Candida krusei | 24210 | $9.3x10^8$ | 2/2 |
| Candida parapsilosis | 14054 | $6.0x10^8$ | 2/2 |
| Candida tropicalis | ARUP 2 | $1.5x10^9$ | 2/2 |
| Cryptococcus neoformans | 90112 | $1.1x10^9$ | 2/2 |
| Mycoplasma | | | |
| Mycoplasma pneumoniae | 15531 | $2.7x10^8$ (gDNA) | 2/2 (6) |

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The vast majority of strains tested 'Staphylococcus NEGATIVE,' indicating no crossreactivity or interference with internal controls. The exceptions were twenty-seven (27) 'invalid' calls and six (6) 'Staphylococcus POSITIVE' calls, all noted in Table 7.

One (1) 'invalid' call out of two (2) tests was observed for a single strain of the following species: Actinomyces odontolyticus, Escherichia coli, Kluyvera intermedia, Moraxella catarrhalis, Neisseria meningitides, Neisseria subflava, Proteus mirabilis, Salmonella typhimurium, and Streptococcus uberis. Each invalid case resolved upon re-testing as ' Staphylococcus NEGATIVE'.

Two (2) 'invalid' calls out of two (2) tests were observed for Mycoplasma pneumoniae upon initial testing. Two (2) valid calls out of two (2) tests were obtained upon retesting as 'Staphylococcus NEGATIVE'.

One (1) 'Staphylococcus POSITIVE' call out of two (2) tests was observed for a single strain of the following species: Arcanobacterium haemolyticum, Macrococcus caseolyticus, Streptococcus mutans, Proteus mirabilis, Serratia liquefaciens. Each positive result resolved upon re-testing as 'Staphylococcus NEGATIVE' with a minimum of six (6) repeat tests, indicating the positive results previously obtained were likely a single contamination event in one card. One or more invalid calls were observed upon re-testing for the following species: Macrococcus caseolyticus, Streptococcus mutans and Serratia liquefaciens as noted in Table 7.

d. Microbial Interference

Off-Panel Microbial Interference: As a follow up to the previous exclusivity and inclusivity studies, the Staph ID/R Blood Culture Panel was further evaluated for the ability to detect low level Staphylococcus species in the presence of fourteen (14) "offpanel" microorqanism strains that should not be detected. The "off-panel" strains represent Gram Positive, Gram Negative, Yeast and likely skin contaminants. BACTEC Plus Aerobic/F or Anaerobic/F Bottles containing blood were inoculated with competing "off-panel" microorganisms. The "off-panel" strains were grown to high concentrations by incubating 8 hours past bottle ring 'On-board', consistent with incubation time and temperatures tested in the specimen stability study. The bottle contents were confirmed by Gram stain and serial dilutions plated on agar and counted the following day to

19

confirm a concentration of >10° CFU/mL. Bottles were stored at 4°C and tested within 72 hours in combination with Staphylococcus TSB cultures at approximately 1-2.5x10° CFU/mL for each strain. The concentration of the Staphylococcus strains were verified by plating serial dilutions on agar and performing colony counts the following day. Results for the studies are shown in Table 8.

Table 8. Microbial Interference Panel (Off-panel): Non-Staphylococcus microbial strains tested for microbial interference in detecting five (5) Staphylococcus strains by the Staph ID/R Blood Culture Panel.

| "Off-Panel" Microorganisms Species,
Sample Input ≥ $10^8$ CFU/mL;
ATCC/NCTC strain # | Species; ATCC Strain #; Sample Input (CFU/mL) | S. aureus
BAA-1682
0.7-1.2x $10^6$ | S. aureus
11632
0.6-1.6x $10^6$ | S. epidermidis
700562
0.8-0.9x $10^6$ | S. epidermidis
700583
0.9-2.2x $10^6$ | S. lugdunensis
49576
1-1.2x $10^6$ |
|--------------------------------------------------------------------------------------------|-----------------------------------------------|-------------------------------------------------|----------------------------------------------|----------------------------------------------------|----------------------------------------------------|-------------------------------------------------|
| Corynebacterium jeikeium 43734 | | 2/2 | 2/2 | 2/2 | 2/2 | 2/2 |
| Enterococcus faecalis 19433 | | 2/2 | 2/2 | 2/2" | 2/2 | 2/2 |
| Enterococcus faecium 19434 | | 2/2 | 2/2 | 2/2" | 2/2 | 2/2 |
| Listeria monocytogenes 19115 | | 2/2 | 2/2 | 2/2" | 2/2" | 2/2 |
| Micrococcus luteus 10240 | | 2/2 | 2/2 | 2/2 | 2/2 | 2/2 |
| Propionibacterium acnes 11827 | | 2/2 | 2/2 | 2/2 | 2/2 | 2/2 |
| Streptoccocus agalactiae 13813 | | 2/2 | 2/2 | 2/2* | 2/2 | 2/2 |
| Streptococcus anginosus 10713 | | 2/2 | 2/2 | 2/2 | 2/2 | 2/2" |
| Streptococcus pneumoniae 27336 | | 2/2 | 2/2 | 2/2 | 2/2 | 2/2 |
| Streptococcus pyogenes 49399 | | 2/2 | 2/2 | 2/2" | 2/2 | 2/2 |
| Escherichia coli 4157 | | 2/2 | 2/2 | 2/2 | 2/2" | 2/2* |
| Klebsiella pneumoniae 700603 | | 2/2 | 2/2 | 2/2 | 2/2 | 2/2 |
| Pseudomonas aeruginosa 10145 | | 2/2 | 2/2 | 2/2 | 2/2 | 2/2 |
| Candida albicans 18804 | | 2/2 | 2/2 | 2/2 | 2/2 | 2/2 |

*This set of test runs also contained 1 "Invalid" run

"This set of test runs initially miscalled, but called correctly with a higher CFU/mL input of the low level target

For the 'valid' runs tested, the potentially interfering 'off-panel' microorqanisms did not interfere with the detection of the Staphylococcus strains, resulting in 'POSITIVE' calls as expected. In some cases, a miscall was observed, and the low-target Staphylococcus strains were re-tested at a higher concentration and resulted in a positive result as expected. The re-tested concentrations are included in the table and were within the 2-3X LoD range for each species.

Staphylococcus Microbial Interference: Twelve (12) Staphylococcus species expected to be co-detected with the low level Staphylococcus species. BACTEC Plus Aerobic/F bottles containing blood were inoculated with Staphylococcus isolates. The bacteria were grown to high concentrations by incubating 8 hours past bottle ring 'Onboard', consistent with incubation time and temperatures tested in the specimen stability study. The bottle contents were confirmed by Gram stain and serial dilutions plated on agar and counted the following day to confirm a concentration of >10° CFU/mL for competing Staphylococcus strains. Bottles were stored at 4°C and tested within 72 hours in combination with Staphylococcus TSB cultures at approximately 1-2.5x100 CFU/mL for each strain. The concentration of the Staphylococcus strains were verified

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by plating serial dilutions on agar and performing colony counts the following day. Results for the studies are shown in Table 9.

Microbial Interference Panel (Staphylococcus): Staphylococcus microbial Table 9. strains tested for microbial interference in detecting five (5) different low level Staphylococcus strains by the Staph ID/R Blood Culture Panel.

| Microbial Interference
Staphylococcus species,
Sample Input ≥ 108 CFU/mL;
ATCC, Clinical # | Species; ATCC Strain #; Sample Input (CFU/mL) | S. aureus
BAA-1682
0.7-1.2x106 | S. aureus
11632
0.6-1.6x106 | S. epidermidis
700562
0.2-0.9x106 | S. epidermidis
700583
0.9-2.2x106 | S. lugdunensis
49576
1-1.2x106 |
|-----------------------------------------------------------------------------------------------------|-----------------------------------------------|---------------------------------------------|------------------------------------------|------------------------------------------------|------------------------------------------------|---------------------------------------------|
| S. aureus BAA-1682, mecA+ | -- | 2/2 | 2/2" | 2/2" | 2/2 | |
| S. aureus 11632, mecA - | 2/2 | -- | 2/2" | 2/2" | 2/2 | |
| S. epidermidis 700562, mecA+ | 2/2 | 2/2 | -- | 2/2" | 2/2 | |
| S. epidermidis 700583, mecA- | 2/2" | 2/2" | 2/2" | -- | 2/2" | |
| S. lugdunensis 49576, mecA - | 2/2 | 2/2 | 2/2" | 2/2" | -- | |
| S. capitis 35661, mecA - | 2/2 | 2/2 | 2/2" | 2/2 | 2/2 | |
| S. caprae 35538, mecA - | 2/2" | 1/2* | 2/2 | 2/2 | 2/2 | |
| S. hominis 27844, mecA - | 2/2 | 2/2 | 2/2" | 2/2 | 2/2" | |
| S. haemolyticus BAA-1693, mecA + | 2/2 | 2/2* | 2/2" | 2/2" | 2/2 | |
| S. pettenkoferii Denys 38, mecA + | 2/2 | 2/2 | 2/2 | 2/2 | 2/2 | |
| S. simulans 27848, mecA - | 2/2 | 2/2 | 2/2" | 2/2 | 2/2 | |
| S. warneri 27830, mecA - | 2/2 | 2/2 | 2/2 | 2/2 | 2/2 | |

*This set of test runs also contained 1 "Invalid" run

"This set of test runs initially miscalled, but called correctly with a higher CFU/mL input of the low level target

Staphylococcus interference was observed for S. aureus with S. epidermidis and S. caprae at initial concentrations tested (5.9E+05 CFU/mL), but the interference was resolved upon re-testing at higher concentrations (1.5E+06 CFU/mL, within 2-3X LoD). There were 13 cases of interference with S. epidermidis at initial concentrations (2.2-2.5E+05 CFU/mL) when tested against S. aureus, S. epidermidis, S. lugdunensis, S. capitis, S. hominis, S. haemolyticus, and S. simulans. Higher concentrations of S. epidermidis resolved the interference (8.5-9.4E+05 CFU/mL, within 2-3X LoD). Two (2) cases of interference were observed with S. lugdunensis: one (1) case with S. epidermidis, one (1) case with S. hominis. Both cases resolved at higher concentrations of S. Jugdunensis (1.2E+06 CFU/mL, within 2-3X LoD).

e. Interfering Substances (Chemical Interference)

The Staph ID/R Blood Culture Panel was evaluated for interference by a panel of sixteen (16) different substances. Substances were spiked into BACTEC Plus Aerobic/F (with resin) or Standard Aerobic/F (without resin) media containing neqative blood incubated 24 hours in a BACTEC Blood Culture Device. Target Staphylococcus cells were combined with the substances at low positive concentrations at approximately 2-3X LoD (1-2.5x10° CFU/mL). The CFU concentrations for each strain were estimated by optical density measurements and then confirmed by colony counting. The studies assessed the detection of the same ten (10) Staphylococcus ATCC strains used for analytical sensitivity and microbial interference: S. aureus, mecA+ strains BAA-1680 and BAA-1682, S. aureus, mecA+ strains 11632 and 6538, S. epidermidis, mecA+ strains 700562 and 51625, S. epidermidis, mecA- strains 700583 and S. lugdunensis, mecA-

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strains 49576 and 43809. ATCC strain, E. faecalis, mecA- 29212, an off-panel "Negative" in the Staph ID/R Blood Culture Panel, was also included in the study to assess chemical interference with the sample processing control and all downstream detection steps.

Similarly to previous studies, a minimum of two replicate assays was performed for each Staphylococcus strain using each substance in a background of BACTEC Plus Aerobic bottles (with resin) or Standard Aerobic bottles (without resin), see Tables 10 and 11.

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Table 10. Interfering Substances Panel (BACTEC Plus with Resin). Staph ID/R Blood Culture Panel performance evaluation for chemical interference in detecting ten (10) different Staphylococcus strains and one (1) off-panel E. faecalis strain.

	Species, ATCC strain, Sample Input (CFU/mL)											Substance Input
Substance Input
Concentration into
Plus Aerobic Media
(with resin)	S. aureus, mecA +		S. aureus, mecA-		S. lugdunensis, mecA -		S. epidermidis, mecA +		S. epidermidis, mecA-		E. faecalis (Neg)	Concentration into
Standard Aerobic
Media (without resin)	S. aureus, mecA +		S. aureus, mecA-		S. lugdunensis, mecA -		S. epidermidis, mecA +		S. epidermidis, mecA-		E. faecalis (Neg)
	BAA-1680
0.9-1.8x106	BAA-1682
1.4-
1.6x106	11632
1.2-2.2x106	6538
1.8-2.2x106	43809
1.1-1.7x106	49576
0.9-1.8x106	51625
0.3-1.5x106	700562
0.3-0.8x106	12228
0.9-1.2x106	700583
0.3-1.9x106	29212
2.4x107	resin)	BAA-1680
0.9-1.8x106	BAA-1682
1.4-1.6x106	11632
1.2-2.2x106	6538
1.8-2.2x106	43809
1.1-1.7x106	49576
0.9-1.8x106	51625
0.3-1.5x106	700562
0.3-0.8x106	12228
0.9-1.2x106	700583
0.3-1.9x106	29212
2.4x107
Whole Blood in ACD
(≥35% v/v)	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	Whole Blood in ACD
(≥35% v/v)	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2
Whole Blood in EDTA
(≥40% v/v)	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	Whole Blood in EDTA
(≥40% v/v)	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2
Whole Blood in
Heparin
(≥40% v/v)	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	Whole Blood in
Heparin
(≥40% v/v)	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2
Whole Blood in
Sodium Citrate
(≥35% v/v)	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	Whole Blood in
Sodium Citrate
(≥35% v/v)	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2
Human Plasma
(≥40%, v/v)	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	Human Plasma
(≥40%, v/v)	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2
Sodium
Polyanetholsulfonate
(≥0.20% w/v)	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	Sodium
Polyanetholsulfonate
(≥0.20% w/v)	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2
Hemoglobin
(≥10 mg/mL)	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	Hemoglobin
(≥10 mg/mL)	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2
y-Globulin
(≥40 mg/mL)	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	y-Globulin
(≥40 mg/mL)	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2
Triglycerides
(≥10 mg/mL)	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2*	Triglycerides
(≥10 mg/mL)	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2
White Blood Cells
(≥40% v/v)	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	White Blood Cells
(≥40% v/v)	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2
Platelets
(≥40% v/v)	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	Platelets
(≥40% v/v)	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2
Unconjugated
Bilirubin (≥0.075
mg/mL)	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	Unconjugated
Bilirubin (≥0.075
mg/mL)	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2
Conjugated Bilirubin
(≥0.075 mg/mL)	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	Conjugated Bilirubin
(≥0.075 mg/mL)	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2*
Vancomycin
(≥50 µg/mL)	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	Vancomycin
(≥50 µg/mL)	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2
Ciprofloxacin
(≥7.5 µg/mL)	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	Ciprofloxacin
(≥7.5 µg/mL)	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2
Cefoxitin
(≥125 µg/mL)	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	Cefoxitin
(≥125 µg/mL)	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2	2/2

*This set of test runs also contained 1 "Invalid" run

In Table 10, the substances did not interfere with detection of strains at the concentrations listed, resulting in Positive or Negative calls as expected.

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Table 11. Interfering Substances Panel (BACTEC Standard without Resin). Staph ID/R Blood Culture Panel performance evaluation for chemical interference in detecting ten (10) different Staphylococcus strains and one (1) off-panel E. faecalis strain.

*This set of test runs also contained 1 "Invalid" run

As summarized in Table 11, the chemical substances tested did not interfere with detection of the majority of strains, resulting in Positive or Negative calls as expected.

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24

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Carry-over/Cross-Contamination Study f.

A study was performed to assess the cross-contamination of the Staph ID/R Blood Culture Panel by alternatively testing high titer S. aureus, mecA+ ATCC strain BAA-1682 and off-target negative E. faecalis ATCC strain 29212. BACTEC Plus Aerobic/F blood bottle containing negative blood were inoculated with strain isolates and incubated until alarm positivity in a BACTEC Blood Culture System. Alarm positive samples were incubated past positivity consistent with timeframes used during the specimen stability studies to obtain a high titer. Alarm positive blood cultures were Gram stained, diluted, plated on aqar plates and colonies were counted the following day to confirm target concentrations >107 for S. aureus (3.0x107 CFU/mL) and >10° E. faecalis (5.8x10' CFU/mL). Aliquots from the high titer blood culture bottles were stored at -20°C until testing. Carry-over/cross-contamination was tested by running a series of alternating runs of high titer positive and negative samples on multiple Portrait Analyzers.

In conclusion, all of the 'calls' were in concordance with expected 'calls'. Therefore, there was no evidence of contamination in any of the tests.

g. Reproducibility

A multicenter, blinded, reproducibility study was performed to determine reproducibility of the Staph ID/R Blood Culture Panel. Testing occurred at three sites using a panel of seven simulated blood culture specimens, each spiked with a single organism. Specimens were prepared in a matrix of whole blood culture media. Half of the replicates for the three Staphylococcus positive samples were consistent with the level of organism present at the time of positivity (low) and half were at a concentration similar to that observed after 8 hours of positivity (high). For the one off-panel organism (E. faecalis; Staph ID/R neqative) the concentration was "high."

The study incorporated several variables including six different operators at three sites (two operators/site), five different cartridge lots, and 89 different Portrait Analyzers (15 at site 1, and 12 at site 3, 62 at site 4). Over the course of 10 weeks, samples were tested on 12 different days, for a total of 90 replicates per analyte per concentration.

Valid results were attained for 630 of 642 (98.1%) runs (see Table 12). For the detection of Staphylococcus positivity (Test result "Positive"), expected positive results were obtained for 540/540 runs (100%), and expected Staphylococcus neqative results (Test result "Negative") were obtained in 87/90 runs (96.7%). For the detection of specific Staphylococcus, expected positive results were obtained for 538/540 runs (99.6%) and expected negative results were obtained for 1341/1350 (99.3%) results (Table 12).

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Table 12. Summary of Reproducibility Study.

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| Staph ID/R
Blood Culture
Panel Result | Species, Bacteria Load (Low or High),
Sample Input (CFU/mL) | Test Site | Detected | Not Detected | %Agreement with
Expected Result |
|---------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|-----------|-------------|--------------|------------------------------------|
| S. aureus,
mecA present | S. aureus (mecA +), Low;
$4.0x10^6$ | 1 | 30/30 | 0/30 | 90/90; 100% |
| | | 3 | 30/30 | 0/30 | |
| | | 4 | 30/30 | 0/30 | |
| | | Total | 90/90 | 0/90 | |
| S. aureus,
mecA present | S. aureus (mecA +) High;
$4.0x10^7$ | 1 | 30/30 | 0/30 | 90/90; 100% |
| | | 3 | 30/30 | 0/30 | |
| | | 4 | 30/30 | 0/30 | |
| | | Total | 90/90 | 0/90 | |
| | Negative | 1 | 1/150 (1) | 149/150 | 448/450; 99.6% |
| | | 3 | 1/150 (2) | 149/150 | |
| | | 4 | 0/150 | 150/150 | |
| | | Total | 2/450 | 448/450 | |
| Staphylococcus
species OTHER
than S. aureus or
S. lugdunensis,
mecA present | S. epidermidis (mecA +), Low;
$8.5x10^6$ | 1 | 30/30 | 0/30 | 90/90; 100% |
| | | 3 | 30/30 | 0/30 | |
| | | 4 | 30/30 | 0/30 | |
| | | Total | 90/90 | 0/90 | |
| Staphylococcus
species OTHER
than S. aureus or
S. lugdunensis,
mecA present | S. epidermidis (mecA +), High;
$7.0x10^7$ | 1 | 30/30 | 0/30 | 90/90; 100% |
| | | 3 | 30/30 | 0/30 | |
| | | 4 | 30/30 | 0/30 | |
| | | Total | 90/90 | 0/90 | |
| | Negative | 1 | 2/150 (3) | 148/150 | 446/450; 99.1% |
| | | 3 | 0/150 | 150/150 | |
| | | 4 | 2/150 (4) | 148/150 | |
| | | Total | 4/450 | 446/450 | |
| S. lugdunensis,
mecA absent | S. lugdunensis (mecA - ), Low;
$6.0x10^7$ | 1 | 28/30 (3) | 2/30 | 88/90; 97.8% |
| | | 3 | 30/30 | 0/30 | |
| | | 4 | 30/30 | 0/30 | |
| | | Total | 88/90 | 2/90 | |
| S. lugdunensis,
mecA absent | S. lugdunensis (mecA - ), High;
$5.1x10^8$ | 1 | 30/30 | 0/30 | 90/90; 100% |
| | | 3 | 30/30 | 0/30 | |
| | | 4 | 30/30 | 0/30 | |
| | | Total | 90/90 | 0/90 | |
| | Negative | 1 | 2/150 (5,6) | 148/150 | 447/450; 99.3% |
| | | 3 | 1/150 (5) | 149/150 | |
| | | 4 | 0/150 | 150/150 | |
| | | Total | 3/450 | 447/450 | |
| Staphylococcus
Positive | S. aureus , S. epidermidis , S. lugdunensis,
Low and High | 1 | 180/180 | 0/180 | 540/540; 100% |
| | | 3 | 180/180 | 0/180 | |
| | | 4 | 180/180 | 0/180 | |
| | | Total | 540/540 | 0/540 | |
| Staphylococcus
Negative | E. faecalis, (mecA - ), High;
$1.1x10^9$ | 1 | 1/30 (6) | 29/30 | 87/90; 96.7% |
| | | 3 | 0/30 | 30/30 | |
| | | 4 | 2/30 (4) | 28/30 | |
| | | Total | 3/90 | 87/90 | |
| Staph ID/R
Blood Culture
Panel Result | Species, Bacteria Load (Low or
High), Sample Input (CFU/mL) | Test Site | Detected | Not Detected | %Agreement with
Expected Result |
| S. aureus, mecA
present | S. aureus (mecA+) , Low;
$4.0x10^6$ | Site 1 | 30/30 | 0/30 | 90/90; 100% |
| | | Site 3 | 30/30 | 0/30 | |
| | | Site 4 | 30/30 | 0/30 | |
| | | Total | 90/90 | 0/90 | |
| S. aureus, mecA
present | S. aureus (mec A+) High;
$4.0x10^7$ | Site 1 | 30/30 | 0/30 | 90/90; 100% |
| | | Site 3 | 30/30 | 0/30 | |
| | | Site 4 | 30/30 | 0/30 | |
| | | Total | 90/90 | 0/90 | |
| | Negative | Site 1 | 0/150 | 150/150 | 450/450; 100% |
| | | Site 3 | 0/150 | 150/150 | |
| | | Site 4 | 0/150 | 150/150 | |
| | | Total | 0/450 | 450/450 | |
| Staphylococcus
species OTHER
than S. aureus or
S. lugdunensis ,
mecA present | S. epidermidis (mec A+) , Low;
$8.5x10^6$ | Site 1 | 30/30 | 0/30 | 90/90; 100% |
| | | Site 3 | 30/30 | 0/30 | |
| | | Site 4 | 30/30 | 0/30 | |
| | | Total | 90/90 | 0/90 | |
| | S. epidermidis (mec A+) , High;
$7.0x10^7$ | Site 1 | 29/30 (1) | 1/30 | 89/90; 98.9% |
| | | Site 3 | 30/30 | 0/30 | |
| | | Site 4 | 30/30 | 0/30 | |
| | | Total | 89/90 | 1/90 | |
| | Negative | Site 1 | 0/150 | 150/150 | 450/450; 100% |
| | | Site 3 | 0/150 | 150/150 | |
| | | Site 4 | 0/150 | 150/150 | |
| | | Total | 0/450 | 450/450 | |
| mecA Present;
no organism
associated | S. aureus (mec A+) ,
S. epidermidis (mecA +)
Low and High | Site 1 | 119/120 | 1/120 | 359/360; 99.7% |
| | | Site 3 | 120/120 | 0/120 | |
| | | Site 4 | 120/120 | 0/120 | |
| | | Total | 359/360 | 1/360 | |
| mecA Absent; no
organism
associated | S. lugdunensis (mecA -) ,
E. faecalis (mecA -)
Low and High | Site 1 | 0/90 | 90/90 | 270/270; 100% |
| | | Site 3 | 0/90 | 90/90 | |
| | | Site 4 | 0/90 | 90/90 | |
| | | Total | 0/270 | 270/270 | |

(1) Sample detected as "Staphylococcus aureus in mixed Staph infection (NOT S. lugdunensis)"

(2) One S. lugdunensis specimen additionally detected S. aureus

(3) Two S. lugdunensis specimens detected as Staphylococcus OTHER than S. aureus or S. lugdunensis

(4) Two E. faecalis specimens detected as Staphylococus OTHER than S. aureus or S. lugdunensis

(5) One specimen detected S. aureus correctly, but additionally detected S. lugdunensis

(6) One E. faecalis specimen detected as S. lugdunensis

27

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For detection of the mecA gene with no associated organism, positive results (mecA Present) were detected in 359/360 (99.7%) runs and negative results (mecA absent) were detected in 270/270 (100%) runs (see Table 13). For S. aureus (mec4+), positive mecA results were obtained for 180/180 (100%) runs and negative mecA results were obtained for 450/450 (100%) runs. For S. epidermidis (mecA+), positive mecA results were obtained for 179/180 (99.4%) runs and negative mecA results were obtained for 450/450 (100%) runs.

	Table 13. Summary of mecA results from Reproducibility Studies.

(1) One Staphylococcus species OTHER than S. aureus or S. lugdunensis, mecA present reported as mecA absent

28

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In the study, ten (10) discrepant results were obtained (see Table 14).

| Correct Result | Staph ID/R Blood Culture Panel Result | Discrepant
Result | Site | Operator | Test
Day |
|-----------------------------------------------------------------------|---------------------------------------------------------------------------------------|----------------------|------|----------|-------------|
| Staphylococcus lugdunensis, mecA absent | Staphylococcus OTHER than S. aureus or
S. lugdunensis, mecA absent | Staph. species | 1 | 1 | 3 |
| Staphylococcus lugdunensis, mecA absent | Staphylococcus OTHER than S. aureus or
S. lugdunensis, mecA absent | Staph. species | 1 | 2 | 4 |
| Negative, mecA N/A | Staphylococcus lugdunensis, mecA absent | S. lugdunensis | 1 | 2 | 5 |
| Staphylococcus aureus, mecA present | Staphylococcus aureus ; Staphylococcus lugdunensis,
mecA present | S. lugdunensis | 1 | 2 | 5 |
| Staphylococcus OTHER than S. aureus or
S. lugdunensis, mecA absent | Staphylococcus OTHER than S. aureus or
S. lugdunensis, mecA absent | mecA absent | 1 | 2 | 5 |
| Staphylococcus OTHER than S. aureus or
S. lugdunensis, mecA absent | Staphylococcus aureus in mixed Staph infection
(NOT S. lugdunensis ), mecA present | S. aureus | 1 | 2 | 5 |
| Staphylococcus aureus, mecA present | Staphylococcus aureus ; Staphylococcus lugdunensis,
mecA present | S. lugdunensis | 3 | 1 | 1 |
| Staphylococcus lugdunensis, mecA absent | Staphylococcus aureus ; Staphylococcus lugdunensis,
mecA absent | S. aureus | 3 | 2 | 2 |
| Negative, mecA N/A | Staphylococcus OTHER than S. aureus or
S. lugdunensis, mecA absent | Staph. species | 4 | 2 | 4 |
| Negative, mecA N/A | Staphylococcus OTHER than S. aureus or
S. lugdunensis, mecA absent | Staph. species | 4 | 2 | 5 |

Table 14. Summary of discrepant results from Reproducibility Studies.

h. Evaluation of Blood Culture Bottle Types

To determine the effect of blood culture bottle type on Staph ID/R Blood Culture Panel, thirteen (13) unique bottle types were tested in the presence of target and non-target orqanisms. Staphylococcus isolates or E. faecalis (neqative) at bottle rinq load levels (2x10°-1x10° CFU/mL) consistent with the specimen stability studies. All bottles were tested with the highest volume of negative blood recommended by the manufacturer (e.g., if the recommended blood volume was 8-10 mL of blood was spiked into the bottle). Bottles with blood were pre-incubated 18 hours at 35-37℃ in a BACTEC Blood Culture System or in a shaking incubator prior to testing. Bacteria isolates were incubated >18 hrs in TSB, and the CFU concentrations for each strain were estimated by optical density measurements, confirmed by serial dilution and colony counting.

The studies assessed the detection of seven (7) Staphylococcus ATCC strains used for analytical sensitivity: S. aureus, mecA+ BAA-1680, S. aureus, mecA+ 1682, S. aureus, mecA- 11632, S. epidermidis, mecA+ 51625, S. epidermidis, mecA- 12228, S. lugdunensis, mecA- 49576, S. capitis, mecA- 35661. The studies also assessed performance of the Staph ID/R Blood Culture Panel in the presence of E. faecalis 29212 (Negative).

The following bottle types were tested in the study: BACTEC (Standard 10 Aerobic/F, Standard Anaerobic 10/F, Plus Aerobic/F, Plus Anaerobic/F, Lytic 10/F, and PEDS Plus/F), BacT/Alert (SA Standard Aerobic, SN Standard Anaerobic, FA FAN Aerobic, FN FAN Anaerobic, and PF Pediatric FAN), and Versa Trek (Redox 1 and Redox 2). Three bottles of each bottle type were used for each strain, and the samples tested three

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times in the Staph ID/R Blood Culture Panel for a total of 9 runs for each strain and bottle type combination.

For the 'valid' runs tested, all of the potential blood bottle types were compatible with the Staph ID/R Blood Culture Panel, with no false negative results (see Table 15).

| Bottle Type | S. aureus (mecA +)
BAA-1680
$1.9x10^7$ | S. aureus (mecA +)
BAA-1682
$1.2x10^7$ | S. aureus (mecA -)
11632
$7.5x10^7$ | S. lugdunensis (mecA -)
49576
$1.9x10^8$ | S. epidermidis (mecA -)
12228
$2.9x10^7$ | S. epidermidis (mecA +)
51625
$6.5x10^7$ | S. capitis (mecA-)
35661
$2.3x10^6$ | E. faecalis (mecA -)
29212
$2.1-4.5x10^7$ |
|--------------------------------|-----------------------------------------------------|-----------------------------------------------------|--------------------------------------------------|-------------------------------------------------------|-------------------------------------------------------|-------------------------------------------------------|--------------------------------------------------|--------------------------------------------------------|
| BACTEC Standard 10 Aerobic/F | 9/9 | 9/9 | 9/9 | 9/9 | 9/9 | 9/9 | 9/9 | 9/9 |
| BACTEC Standard Anaerobic 10/F | 9/9 | 9/9 | 9/9 | 9/9 | 9/9 | 9/9 | 9/9 | 9/9 |
| BACTEC Plus Aerobic/F | 9/9 | 9/9 | 9/9 | 9/9 | 9/9 | 9/9 | 9/9 | 9/9 |
| BACTEC Plus Anaerobic/F | 9/9 | 9/9 | 9/9 | 9/9 | 9/9 | 9/9 | 9/9 | 9/9 |
| BACTEC Lytic 10/F | 9/9 | 9/9 | 9/9 | 9/9 | 9/9 | 9/9 | 9/9 | 9/9 |
| BACTEC PEDS Plus/F | 9/9 | 9/9 | 9/9 | 9/9 | 9/9 | 9/9 | 9/9 | 14/14**** |
| BacT/Alert SA Aerobic | 9/9 | 9/9 | 9/9 | 9/9 | 9/9 | 9/9 | 9/9 | 16/16** |
| BacT/Alert SN Anaerobic | 9/9 | 9/9 | 9/9 | 9/9 | 9/9 | 9/9 | 9/9 | 16/17*" |
| BacT/Alert FA FAN Aerobic | 9/9 | 9/9 | 9/9 | 9/9 | 9/9 | 9/9 | 9/9 | 9/9 |
| BacT/Alert FN FAN Anaerobic | 9/9 | 9/9 | 9/9 | 9/9 | 9/9 | 9/9 | 9/9 | 9/9 |
| BacT/Alert PF Pediatric FAN | 9/9 | 9/9 | 9/9 | 9/9 | 9/9 | 9/9 | 9/9 | 17/17** |
| Versa Trek Redox 1 | 9/9 | 9/9 | 8/9' | 9/9 | 9/9 | 9/9 | 9/9 | 9/9 |
| Versa Trek Redox 2 | 9/9 | 9/9 | 9/9 | 9/9 | 9/9 | 9/9 | 9/9 | 9/9 |

*This set of test runs also contained 1 "Invalid" run

**This set of test runs also contained 2 "Invalid" runs

***This set of test runs also contained 4 "Invalid" runs

'This set of test runs contained 1 false positive result for mecA

"This set of test runs contained 1 false positive Staphylococcus, species undetermined result

Table 15. Evaluation of blood culture bottle types study results.

A false positive " S. aureus, mecA Present" result was observed in one test run from one Versa Trek Redox 1 bottle for S. aureus, mecA- 11632. The discrepant result is thought to be a contamination event, since all other samples (8/9) gave the correct "S. aureus present, mecA Absent" call, including 2/3 correct results from the same bottle with the discrepant call. All test results did result in a correct S. aureus result, suggesting that the bottle type did not interfere with the assay.

A false positive " Staphylococcus Positive, Staphylococcus species OTHER than S. aureus or S. lugdunensis, mecA absent" result was observed for E. faecalis 29212 in one test run from one BacT/Alert SN Anaerobic bottle. The discrepant result is also thought to be a random contamination event, because the sixteen (16) other "valid" test runs returned a correct "Staphylococcus Negative" result, including 2/3 correct initial results and 3/3 correct re-test results from the same bottle with the discrepant call.

The only other exceptions observed during this study were nine (9) 'Invalid' call runs that are noted in Table 15, all with E. faecalis 29212. When tested with E. faecalis 29212, one (1) invalid run was observed for BACTEC PEDS Plus/F, one (1) invalid run for BacT/Alert SA Aerobic, and one (1) invalid run for BacT/Alert PF Pediatric FAN bottle types. In all of these cases, extra test runs were performed to evaluate any possible

Great Basin Scientific, Inc. 2441 S. 3850 W. Salt Lake City, UT 84120 www.gbscience.com phone: 801-990-1055 fax: 801-990-1051

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interference with the assay in a Negative sample (evaluating SPC only). Re-test with nine (9) cards resulted in an additional three (3) invalid runs for BACTEC PEDS Plus/F, one (1) invalid run for BacT/Alert SA Aerobic, and one (1) invalid run for BacT/Alert SN Anaerobic (retested due to false positive contamination result). Overall, it appears that the bottle types with invalid results have an elevated invalid rate (5-28%) compared to the prospective study (2%).

H. Performance Data - Prospective Clinical Studies

Specimens for the clinical study were collected prospectively at three geographically diverse U.S. sites. Eligible study subjects included individuals receiving routine care requiring blood culture testing. Blood culture specimens were collected from the patients and incubated on the BACTEC continuous monitoring blood culture system. Bottles that were flagged positive by the instrument were Gram stained and then bottles confirmed to contain gram-positive cocci in clusters (GPCC) or gram-positive cocci in singles (GPC) were then tested with the Staph ID/R Blood Culture Panel. A total of 853 samples were collected for all three sites combined. Twenty-two (22) specimens were excluded from the Staph ID/R Blood Culture Panel clinical study dataset. The remaining 831 clinical specimens met the inclusion criteria and were used in the prospective study to evaluate the performance of the Staph ID/R Blood Culture Panel. A total of 762 prospective specimens were tested in the clinical trial, while the remaining 69 archived frozen specimens were tested after the prospective clinical trial.

In addition, 102 Staph ID/R Blood Culture Panel assays were performed on a 'Low Prevalence' panel of contrived or 'simulated' blood culture specimens, consisting of low prevalence Staphylococcus species and gram-positive negatives. These specimens were prepared by spiking blood culture bottles containing whole blood with bacterial suspensions of bacterial isolates. Prepared blood culture bottles were then grown to positivity on the BACTEC blood culture system until flagged positive. Gram stain was performed to verify the presence of gram-positive cocci in clusters (GPCC) or gram-positive cocci in singles (GPC) and then testing was performed with the Staph ID/R Blood Culture Panel. Results from the studies of all three clinical sites combined are summarized in Table 16.

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Table 16. Summary of Clinical Performance of Staph ID/R Blood Culture Panel versus Reference Method(s) – Prospective and Simulated/Supplemental Blood Cultures.

	% Agreement
All sites combined		TP/TP +
FN	PPA
95% CI	TN/TN + TP	NPA
95% CI
Detection of Staphylococcus aureus	Prospective	211/214	98.6%
96.0 - 99.5%	548/551	99.5%
98.4 - 99.8%
	Simulated	0	N/A	102/102	100.0%
96.4 - 100%
	Overall	211/214	98.6%
96.0 - 99.5%	650/653	99.5%
98.7 - 99.8%
Detection of Staphylococcus lugdunensis	Prospective	3/3	100.0%
43.9 - 100%	761/762	99.9%
99.3 - 99.9%
	Simulated	30/30	100.0%
88.7 - 100%	72/72	100.0%
94.9 - 100%
	Overall	33/33	100.0%
89.6 - 100%	833/834	99.9%
99.3 - 99.9%
Detection of Staphylococcus species OTHER than S. aureus
or S. lugdunensis	Prospective	444/449	98.9%
97.4 - 99.5%	307/316	97.2%
94.7 - 98.5%

Detection of mecA with Staphylococcus aureus	Prospective	68/72	94.4%
86.6 - 97.8%	682/690	98.8%
97.7 - 99.4%
	Frozen	35/35	100.0%
90.1 - 100.0%	34/34	100.0%
89.9 - 100.0%
	Overall	103/107	96.3%
90.8 - 98.5%	716/724	98.9%
97.8 - 99.4%
Detection of mecA with Staphylococcus lugdunensis	Prospective	0/0	N/A	762/762	100.0%
99.5 - 100%
Detection of mecA with Staphylococcus species OTHER
than S. aureus or S. lugdunensis	Prospective	243/262	92.7%
88.1 - 97.1%	481/500	96.2%
92.4 - 98.0%

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Table 17 lists all polymicrobial specimens from the prospective performance data determined by the Staph ID/R Blood Culture Panel and/or Reference Method(s).

Table 17. Polymicrobials - Mixed Specimen Combinations Detected by Staph ID/R Blood
Culture Panel and Reference Method(s).

Staph ID/R Result			Reference Result			Discrepant Result Description
Site	Sample ID	Species Identification	mecA Result	Organism 1	Cefoxitin Result	Organism 2	Cefoxitin Result	Organism 3	Species Identification	mecA Result
Polymicrobial for both Staph ID/R Blood Culture Panel AND Reference Results
Site 2 (Daly)	DALY125	S. aureus in mixed Staph infection (NOT S. lugdunensis)	Present	S. aureus	Sensitive	S. epidermidis	Resistant		Correct species call	Correct mecA call
Polymicrobial for Reference Results
Site 1, IU (Denys)	DNYS031	Staph. species OTHER than S. aureus or S. lugdunensis	Absent	S. aureus	Sensitive	S. epidermidis	Sensitive	S. hominis	FN for S. aureus; Correct for Staph call	Correct mecA call
Site 1, IU (Denys)	DNYS033	Staph. species OTHER than S. aureus or S. lugdunensis	Absent	S. capitis	Sensitive	S. epidermidis	No growth		Correct species call	Correct mecA call
Site 1, IU (Denys)	DNYS047	Staph. species OTHER than S. aureus or S. lugdunensis	Present	S. capitis	Sensitive	S. epidermidis	Resistant		Correct species call	Correct mecA call
Site 1, IU (Denys)	DNYS071	Staph. species OTHER than S. aureus or S. lugdunensis	Absent	S. epidermidis	Sensitive	S. haemolyticus	Sensitive		Correct species call	Correct mecA call
Site 1, IU (Denys)	DNYS123	Staph. species OTHER than S. aureus or S. lugdunensis	Present	S. hominis	Resistant	S. epidermidis	Resistant		Correct species call	Correct mecA call
Site 1, IU (Denys)	DNYS191	Staph. species OTHER than S. aureus or S. lugdunensis	Present	S. hominis	Resistant	S. epidermidis	Resistant		Correct species call	Correct mecA call
Site 1, IU (Denys)	DNYS202	Staph. species OTHER than S. aureus or S. lugdunensis	Absent	S. epidermidis	Sensitive	S. epidermidis	Resistant		Correct species call	FN mecA
Site 1, IU (Denys)	DNYS288	Staph. species OTHER than S. aureus or S. lugdunensis	Absent	S. capitis	Sensitive	S. pettenkoferi	Resistant		Correct species call	FN mecA
Site 1, IU (Denys)	DNYS297	Staph. species OTHER than S. aureus or S. lugdunensis	Present	S. hominis	Resistant	S. capitis	Sensitive		Correct species call	Correct mecA call
Site 1, IU (Denys)	YNG109	Staph. species OTHER than S. aureus or S. lugdunensis	Absent	S. epidermidis	Sensitive	S. capitis	Sensitive		Correct species call	Correct mecA call
Site 3, TriCore (Young)	YNG129	Staph. species OTHER than S. aureus or S. lugdunensis	Absent	S. epidermidis	Sensitive	S. warneri	Sensitive		Correct species call	Correct mecA call
Site 3, TriCore (Young)	YNG172	Staph. species OTHER than S. aureus or S. lugdunensis	Present	S. epidermidis	Resistant	S. haemolyticus	Sensitive		Correct species call	Correct mecA call
Site 3, TriCore (Young)	YNG197	Staph. species OTHER than S. aureus or S. lugdunensis	Absent	S. hominis	Sensitive	S. capitis	Sensitive		Correct species call	Correct mecA call
Polymicrobial for Staph ID/R Blood Culture Panel - 'mixed Staph infections'
Site 1, IU (Denys)	DNYS026	S. aureus in mixed Staph infection (NOT S. lugdunensis)	Present	S. hominis	Resistant				FP for S. aureus; Correct for Staph call	Correct mecA call
Site 1, IU (Denys)	DNYS045	S. aureus in mixed Staph infection (NOT S. lugdunensis)	Present	S. aureus	Sensitive				Correct for S. aureus; FP for mixed	FP mecA
Site 3, TriCore (Young)	YNG207	S. aureus in mixed Staph infection (NOT S. lugdunensis)	Present	S. epidermidis	Resistant				FP for S. aureus; Correct for Staph call	Correct mecA call
Site 3, TriCore (Young)	YNG299	S. aureus in mixed Staph infection (NOT S. lugdunensis)	Absent	S. epidermidis	Sensitive				FP for S. aureus; Correct for Staph call	Correct mecA call

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Table 18 summarizes the prospective and 'Low Prevalence' simulated performance data for Staphylococcus genus-level analyte in the Staph ID/R Blood Culture Panel, i.e., the 'Staphylococcus OTHER than S. aureus or S. lugdunensis' analyte. The performance data are stratified by individual Staphylococcus species as determined by the Reference Method(s).

Table 18. Summary of Staphylococcus Genus-level Analyte for "Staphylococcus OTHER than S. aureus or S. lugdunensis versus Reference Method(s).

	% Agreement (95% CI)
Species	Prospective	Simulated
S. arlettae	-	3/3
100%
43.9-100%
S. auricularis	-	3/3
100%
43.9-100%
S. capitis	35/35
100%
90.1-100%	-
S. carnosus	1/1
100%
20.7-100%	-
S. cohnii	2/2
100%
34.2-100%	3/3
100%
43.9-100%
S. equorum	2/2
100%
34.2-100%	-
S. haemolyticus	15/15
100%
79.6-100%	3/3
100%
43.9-100%
S. hominis	96/97
97.9%
92.8-99.4%	-
S. intermedius	-	3/3
100%
43.9-100%
S. pettenkoferi	7/7
100%
64.6-100%	-
S. saprophyticus	8/8
100%
67.6-100%	-
S. schleiferi	2/2
100.0%
67.6-100%	3/3
100%
43.9-100%
S. sciuri	-	3/3
100%
43.9-100%
S. simulans	2/2
100%
34.2-100%	3/3
100.0%
43.9-100%
S. species	2/2
100%
34.2-100%	-
S. warneri	8/8
100%
67.6-100%	3/3
100%
43.9-100%
S. xylosus	-	3/3
100%
43.9-100%

Great Basin Scientific, Inc. 2441 S. 3850 W. Salt Lake City, UT 84120 www.gbscience.com phone: 801-990-1055 fax: 801-990-1051

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I. Invalid and Abort Rates

Invalid rates and run abort rates for the prospective clinical studies are found in Table 19. The overall initial Invalid rate in the prospective clinical studies was 1.39%. Valid results were achieved after a single retest for all of the Invalid runs, resulting in a final Invalid rate of 0%. For run aborts, the overall abort rate for the prospective clinical studies was 3.30%. All of these specimens were later run successfully resulting in a final abort rate of 0.00%. All run aborts are referred as "Test Incomplete" by the Portrait Staph ID/R Blood Culture Panel software.

Table 19. Invalids and Aborts with Prospective Clinical Specimens.

| Clinical Site | # Runs | # of
Initial
Invalids | Initial
Invalid Rate | # of Final
Invalids | Final
Invalid
Rate | # of
Initial
Aborts | Initial Abort
Rate | # of Final
Aborts | Final
Abort
Rate |
|-------------------------|--------|-----------------------------|-------------------------|------------------------|--------------------------|---------------------------|-----------------------|----------------------|------------------------|
| Site 1, IU (Denys) | 332 | 4 | 1.20% | 0 | 0.00% | 10 | 3.01% | 0 | 0.00% |
| Site 2, PCMC (Daly) | 157 | 4 | 2.55% | 0 | 0.00% | 6 | 3.82% | 0 | 0.00% |
| Site 3, TriCore (Young) | 300 | 3 | 1.00% | 0 | 0.00% | 10 | 3.33% | 0 | 0.00% |
| Overall | 789 | 11 | 1.39% | 0 | 0.00% | 26 | 3.30% | 0 | 0.00% |

No Call rates (invalid + abort rates) for the prospective clinical studies are found in Table 20. The overall initial No Call Rate was 4.69%. All Invalid runs and run aborts were later run successfully, resulting in a final No Call rate of 0.00%.

Table 20. Prospective Clinical Specimens with "No Call" (Invalids + Aborts).

| Clinical Site | # of Runs | Initial No Call
(Invalids + Aborts) | Initial No Call Rate
(Invalids + Aborts) | Final No Call
(Invalids + Aborts) | Final No Call Rate
(Invalids + Aborts) |
|-------------------------|-----------|----------------------------------------|---------------------------------------------|--------------------------------------|-------------------------------------------|
| Site 1, IU (Denys) | 332 | 14 | 4.22% | 0 | 0.00% |
| Site 2, PCMC (Daly) | 157 | 10 | 6.37% | 0 | 0.00% |
| Site 3, TriCore (Young) | 300 | 13 | 4.33% | 0 | 0.00% |
| Overall | 789 | 37 | 4.69% | 0 | 0.00% |

J. Conclusion

The submitted information in this product notification is complete and supports a substantial equivalence decision.