← Product Code [LIE](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LIE) · K103456

# THE SENSITITRE AIM (K103456)

_Trek Diagnostic Systems · LIE · Jun 22, 2011 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LIE/K103456

## Device Facts

- **Applicant:** Trek Diagnostic Systems
- **Product Code:** [LIE](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LIE.md)
- **Decision Date:** Jun 22, 2011
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.1640
- **Device Class:** Class 2
- **Review Panel:** Microbiology

## Indications for Use

The Sensititre® AIM™ is intended for use with the Sensititre® MIC or BP Susceptibility Test System. The Sensititre® AIM™ is an instrument used to inoculate Sensititre® MIC or BP Susceptibility plates. The Sensititre MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of gram positive and fastidious organisms comprising of Haemophilus influenzae, Streptococci pneumoniae, other Streptococci spp. and Candida spp.

## Device Story

Sensititre AIM™ is a microprocessor-controlled, bench-top automated pipette system for inoculating 96-well micro-titre plates used in antimicrobial susceptibility testing (AST). User prepares bacterial suspension; affixes disposable dosehead to glass tube; places tube into pump assembly. User selects well dose volume (50μl multiples) via graphical display. Instrument dispenses inoculum into plates. Stand-alone device; no sample tracking or external connectivity. Healthcare providers use output (MIC plates) to determine bacterial susceptibility to antimicrobial agents, aiding clinical treatment decisions. Benefits include standardized, automated inoculation compared to manual methods.

## Clinical Evidence

No clinical data provided; device is an automated laboratory instrument for plate inoculation.

## Technological Characteristics

Microprocessor-controlled pump assembly; dispenses 50µl multiples; utilizes disposable doseheads; designed for 96-well microtiter plates; standalone laboratory instrument.

## Regulatory Identification

An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE

A. 510(k) Number:
k103456

B. Purpose for Submission:
To obtain substantial equivalence for the Autoinoculator 2, AIM™ inoculation system compared to the existing Autoinoculator I.

C. Measurand:
Antimicrobial susceptibility testing of Gram positive organisms, Streptococci, H. influenzae, and C. albicans on the Sensititre panels inoculated with AIM.

D. Type of Test:
Quantitative Antimicrobial Susceptibility Test (AST), growth based fluorescence. The minimum inhibitory concentration (MIC) is determined manually based on visual detection of growth or by the aid of a manual mirror viewer, an AutoReader or on the VIZION.

E. Applicant:
Trek Diagnostic Systems.

F. Proprietary and Established Names:
Sensititre 18 – 24 hour Susceptibility MIC Plates
Sensititre AIM™ inoculation system

G. Regulatory Information:
1. Regulation section:
21 CFR 866.1640 Antimicrobial Susceptibility Test Powder
2. Classification:
Class II

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2

3. Product code:
LIE-Reagents/Device, Inoculum Calibration
JWY-Manual readings of AST testing of >16 hour incubation
LRG-Automated readings of AST of >16 hrs incubation

4. Panel:
83, Microbiology

H. Intended Use:

1. Intended use(s):
The Sensititre® AIM™ is intended for use with the Sensititre® MIC or BP Susceptibility Test System. The Sensititre® AIM™ is an instrument used to inoculate Sensititre® MIC or BP Susceptibility plates.

The Sensititre MIC and Breakpoint Susceptibility system is an in vitro diagnostic product for clinical susceptibility testing of Gram positive organisms, Streptococci, H. influenzae, and C. albicans.

1. Indication(s) for use:
The Sensititre® AIM™ is intended for use with the Sensititre® MIC or BP Susceptibility Test System. The Sensititre® AIM™ is an instrument used to inoculate Sensititre MIC or BP Susceptibility plates.

The Sensititre MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of Gram positive organisms, Streptococcus pneumoniae, other Streptococcus spp., H. influenzae, and Candida spp.

This 510(k) is for the addition of: "AIM™"

The Sensititre AIM™ is a microprocessor controlled instrument that delivers inoculum in 50μl multiples to the Sensititre 96 well micro-titre plate. The user prepares the inoculum suspension in accordance with the package inert. A Sensititre disposable dosehead is affixed to the glass tube containing the final inoculum density which is placed into the AIM's pump assembly. The inoculum is then dispensed into the microtitre plates.

3. Special conditions for use statement(s):
Prescription use only.

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4. Special instrument requirements:

The Sensititre AutoReader

The Sensititre viewer, VIZION

The Sensititre Autoinoculator 2, AIM™ instrument

I. Device Description:

The Sensititre Autoinoculator 2, AIM™ instrument is an automated pipette system for the delivery of user prepared inoculated media in multiples of 50 and 100 µl into the Sensititre 96 well antimicrobial susceptibility plate.

The AIM™ is a bench-top instrument which dispenses bacterial suspension (inoculum) into a 96-well plate (MIC panel). The instrument has a display which presents options to the user graphically. The user may then select the well dose volume (a multiple of 50 µl) specific to each panel section. Different panel sections may be dosed differently. After selection of these parameters, the user loads the inoculum tube, a suitable panel and then starts the dosing cycle.

The AIM™ is a stand-alone device and requires no connections to other equipment in normal use. It currently provides no support for sample tracking.

J. Substantial Equivalence Information:

1. Predicate device name(s):

Autoinoculator I

2. Predicate K number(s):

k081063

3. Comparison with predicate:

|  Similarities  |   |   |
| --- | --- | --- |
|  Item | Device | Predicate  |
|  Intended Use | Delivery of prepared inoculum media in multiples of 50 µl into 96 microplate wells | Same  |
|  Inoculation and test organism | Isolated colonies from culture are used to prepare the inoculum | Same  |

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|  Similarities  |   |   |
| --- | --- | --- |
|  Item | Device | Predicate  |
|  Dosing system /Technology | Automated pipette system using TREK dosehead consumables | Same  |
|  Well indexing method | Microplate wells are indexed beneath the dose head | Same  |
|  Calibration method | System is calibrated by weighing dosed plates | Same  |
|  Type of test | Automated or manual | Same  |
|  Differences  |   |   |
| --- | --- | --- |
|  Item | Device | Predicate  |
|  Size | 250 mm wide/350 mm deep | 413 mm wide/464 mm deep  |
|  Cycle speed | Between 27 and 35 seconds | 35 seconds  |
|  Dose head drive system | Single stepper motor articulating mechanically slaved rotation and thrusting movements of dose head drive spigot | Two stepper motors. First stepper motor articulating rotation movement of dose head drive spigot. Second stepper motor articulating thrusting movements of dose head drive spigot  |
|  User interface | Single line LED display with keypad | Touch screen display with icon driven menu system  |

K. Standard/Guidance Document Referenced (if applicable):

1. Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm071462.pdf

2. Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically, Approved Standard -8th Edition, Document M7-A8.

3. CLSI. Performance Standards for Antimicrobial Susceptibility Testing – 19th Informational Supplement, Document M100-S19.

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L. Test Principle:

Sensititre susceptibility plates are multi-well plastic microtiter plates that contain doubling dilutions of antibacterial agents. Each plate is dosed with antimicrobial agents at appropriate dilutions. Results can be read manually by visual reading of growth or automatically on an AutoReader using fluorescence. The Sensititre AutoReader system utilizes fluorescence technology which involves the detection of bacterial growth by monitoring the activity of specific surface enzymes produced by the test organism. Growth is determined by generating a fluorescent product from a non-fluorescent (fluorogenic) substrate. The substrate can be added to the inoculum broth and dispensed into the test plates at the same time as the test organism or the plates can be prepared with the substrate already added to the plate. The non-fluorescent substrate is prepared by conjugating a fluorescent compound to the specific enzyme substrates with a bond, which prevents fluorescence (i.e. the fluorophore is quenched in this state). Enzymatic action of the bacterial surface enzymes on the specific substrates cleaves this bond releasing the fluorophore which is now capable of fluorescence. The amount of fluorescence detected is directly related to the activity of the bacterial surface enzymes and, therefore, to bacterial growth.

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

A reproducibility study was conducted at three study sites. For each group of organisms, twenty five isolates were inoculated using the AIM and tested at each site. The panels used included the antimicrobial agents as representatives of the various classes. These panels were tested one time at each of the three sites and results were read by both the AutoReader and the VIZION. The reproducibility of MIC tests was performed using Sensititre plates read on the VIZION, AutoReader, and/or mirror as follows

Gram positive - Read on AutoReader and VIZION
Streptococcus spp. - Read on AutoReader and VIZION
Haemophilus spp. - Read on the VIZION
Candida spp. - Read on manual mirror

Reproducibility was calculated as the percent of combined results were within +/- one doubling dilution of the mode MIC value for all sites.

The original AIM reproducibility studies included several drug/organism combinations that did not have sufficient number of on-scale MIC results.

Another reproducibility study was conducted and included 10 isolates with on-scale MIC values for the antimicrobials that were not on-scale. Cumulative

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reproducibility data is shown below.

Overall Reproducibility of AIM vs. Autoinoculator I for Gram Positive organisms

|   | % Reproducibility (AIM vs. Autoinoculator I)  |   |   |
| --- | --- | --- | --- |
|   | Best Case (assuming off scale result is within one well from the mode) | On scale (on scale values only) | Worst case* (assuming off scale result is greater than one well from the mode)  |
|  AutoReader | 99.8 | 99.9 | 86.4  |
|  VIZION | 99.7 | 99.7 | 85.8  |

* Off-scale isolates were used due to unavailability or insufficient number of isolates with on-scale MIC values for some drug/organism combinations

Overall Reproducibility of AIM vs. Autoinoculator I for Streptococcus spp.

|   | % Reproducibility (AIM vs. Autoinoculator I)  |   |   |
| --- | --- | --- | --- |
|   | Best Case (assuming off scale result is within one well from the mode) | On scale (on scale values only) | Worst case* (assuming off scale result is greater than one well from the mode)  |
|  AutoReader | 99.8 | 99.7 | 81.2  |
|  VIZION | 99.6 | 99.6 | 80.2  |

* Off-scale isolates were used due to unavailability or insufficient number of isolates with on-scale MIC values for some drug/organism combinations

Overall Reproducibility of AIM vs. Autoinoculator I for Haemophilus influenzae.

|   | % Reproducibility (AIM vs. Autoinoculator I)  |   |   |
| --- | --- | --- | --- |
|   | Best Case (assuming off scale result is within one well from the mode) | On scale (on scale values only) | Worst case* (assuming off scale result is greater than one well from the mode)  |
|  VIZION | 99.7 | 99.8 | 99.4  |

* Off-scale isolates were used due to unavailability or insufficient number of isolates with on-scale MIC values for some drug/organism combinations

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Overall Reproducibility of AIM vs. Autoinoculator I for C. albicans

|   | % Reproducibility (AIM vs. Autoinoculator I)  |   |   |
| --- | --- | --- | --- |
|   | Best Case (assuming off scale result is within one well from the mode) | On scale (on scale values only) | Worst case* (assuming off scale result is greater than one well from the mode)  |
|  Manual Mirror | 99.7 | 99.8 | 99.4  |

* Off-scale isolates were used due to unavailability or insufficient number of isolates with on-scale MIC values for some drug/organism combinations

Even though the MIC values were off-scale for a large number of isolates (varied by drug-organism combinations), which has resulted in low performance based on "worst-case" calculation, the overall reproducibility was considered acceptable, since best-case and on-scale reproducibility were greater than 95%.

b. Linearity/assay reportable range:

Not applicable

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

The FDA and CLSI recommended QC isolates were tested on every test occasion at each clinical site. The QC results obtained using Autoinoculator I and AIM were in range for every day tested.

Quality Control was performed at all sites during the studies using the existing Autoinoculator I and the new Autoinoculator, AIM. Results were read either on a manual mirror, the AutoReader, or the VIZION as appropriate for the organism.

S. aureus ATCC 29213

E. faecalis ATCC 29212, ATCC 51299

S. pneumoniae ATCC 49619

H. influenzae ATCC 49247, ATCC 49766

C. parapsilosis ATCC 22019

C. krusei ATCC 6258

S. aureus ATCC BAA-976 (Cefoxitin screen & Dtest),

S. aureus ATCC BAA-977 (Dtest)

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The QC MIC values obtained by the AIM/Autoinoculator I were comparable. For some drugs, the concentration range was not sufficiently broad to provide definite MIC value for both QC organisms. However, the concentration range was sufficient to evaluate at least one QC organism per drug.

Percentage of results within the acceptable QC range

|   |  | AutoReader |   | VIZION  |   |
| --- | --- | --- | --- | --- | --- |
|  QC Organism(s) | Antimicrobial Agent | Autoinoculator I | AIM | Autoinoculator I | AIM  |
|  S. aureus ATCC 29213
E. faecalis ATCC 29212 | Chloramphenicol
Ciprofloxacin
Clindamycin
Daptomycin
Erythromycin
Gentamicin
Linezolid
Oxacillin
Penicillin
Quinapristin/Dalfapristin
Rifampin
Tetracycline
Trimethoprim/Sulfamethoxazole
Vancomycin | 100% | 100% | 100% | 100%  |
|  S. aureus ATCC BAA-977, & ATCC BAA-976 | Inducible Clindamycin (Dtest) | 100% | 100% | 100% | 100%  |
|  S. aureus ATCC BAA-976, & S. aureus ATCC 29213 | Cefoxitin screen | 100% | 100% | 100% | 100%  |
|  E. faecalis ATCC 29212, ATCC 51299, & S. aureus ATCC 29213 | Gentamicin 500
Streptomycin 1000 | 100% | 100% | 100% | 100%  |
|  S. pneumoniae ATCC 49619 | Amoxicillin/Clavulanic Acid
Cefepime
Cefotaxime
Chloramphenicol
Clindamycin |  |  |  |   |

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|   |  | AutoReader |   | VIZION  |   |
| --- | --- | --- | --- | --- | --- |
|  QC Organism(s) | Antimicrobial Agent | Autoinoculator I | AIM | Autoinoculator I | AIM  |
|   | Daptomycin
Erythromycin
Levofloxacin
Linezolid
Meropenem
Penicillin
Trimethoprim/Sulfamethoxazole
Tetracycline
Vancomycin | 100% | 100% | 100% | 100%  |
|  H. influenzae ATCC 49247 | Amoxicillin/Clavulanic Acid
Ampicillin
Ampicillin/Sulbactam
Cefepime
Cefixime
Ceftriaxone
Chloramphenicol
Clarithromycin
Tetracycline
Trimethoprim/Sulfamethoxazole | 100% | 100% | 100% | 100%  |
|  H. influenzae ATCC 49766 | Cefaclor
Cefuroxime
Imipenem
Meropenem | 100% | 100% | 100% | 100%  |
|  C. parapsilosis ATCC 22019
C. krusei ATCC 6258 | 5-Flucytosine
Fluconazole
Itraconazole
Voriconazole | 100% | 100% | 100% | 100%  |

MIC results were in range for each drug for at least one Quality Control organism tested. Quality Control results for the Sensititre Susceptibility System using AIM as the inoculator or the existing Autoinoculator I demonstrated that the system could produce the expected quality control results whether results are read on the AutoReader or on the VIZION.

The Sensititre Nephelometer was used at each site to standardize the inoculum and it was calibrated every time it was switched on. Colony counts from QC and in-house source was performed using direct inoculum method and the mean result was within the minimum and maximum ranges" All results were within the expected range.

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d. Detection limit:

Not applicable.

e. Analytical specificity:

Not applicable.

f. Assay cut-off:

Not applicable

2. Comparison studies:

a. Method comparison with predicate device:

Performance was established through a clinical study which was conducted at three sites. The studies were designed to evaluate performance of the updated version of the Autoinoculator, AIM to the existing Autoinoculator I using the Sensititre 18-24 hour susceptibility plates. Specially prepared MIC susceptibility panels containing serial dilutions of selected antimicrobial agents representing various classes of antimicrobial agents were inoculated by either the AIM or the Autoinoculator I. Duplicate plates were inoculated. One was inoculated using the Autoinoculator I and the other using the AIM. Plates were read after 18-24 hours of incubation at 35°C. The plate readings were made either on a manual mirror, the AutoReader, or the VIZION as appropriate for the organism. The MIC results obtained for plates inoculated with Autoinoculator I were compared to those obtained for plates inoculated with the AIM. The criteria outlined in the AST Special Controls Guidance Document were used in evaluation of performance of AIM as follows:

AutoReader results comparing AIM versus Autoinoculator I

VIZION results comparing AIM versus Autoinoculator I

Mirror read results comparing AIM versus Autoinoculator I

Clinical testing was performed on Gram positive isolates (89 S. aureus, 61 Staphylococcus spp., 56 Enterococcus spp., 157 beta hemolytic Streptococcus spp, 84 Streptococcus pneumoniae, and 72 viridans streptococci), 195 isolates of H. influenzae and 303 Candida spp. The growth rate for the clinical and challenge isolates was 100%. The performance evaluations are shown in the tables below.

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# Summary Table (AutoReader)

Clinical and challenge isolate results summary for the AIM vs. Existing Autoinoculator (AutoReader)

|  Drug | Organism Group | Clinical | Challenge | Total | Total Evaluable | %EA Total | % EA of Evaluable | %CA | S | I | R or NS | VMJ | MAJ | Minor  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  Oxacillin + 2% NaCl | Coagulase Negative Staph | 42 | 19 | 61 | 30 | 98.4 | 96.7 | 100 | 23 | 0 | 38 | 0 | 0 | 0  |
|  Oxacillin + 2% NaCl | Staphylococcus aureus | 62 | 27 | 89 | 55 | 100 | 100 | 100 | 47 | 0 | 42 | 0 | 0 | 0  |
|  |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Penicillin | Coagulase Negative Staph | 42 | 19 | 61 | 39 | 100 | 100 | 100 | 12 | 0 | 12 | 0 | 0 | 0  |
|  Penicillin | Enterococcus sp. | 40 | 16 | 56 | 41 | 100 | 100 | 100 | 41 | 0 | 41 | 0 | 0 | 0  |
|  Penicillin | Staphylococcus aureus | 62 | 27 | 89 | 30 | 100 | 100 | 100 | 12 | 0 | 12 | 0 | 0 | 0  |
|  Penicillin | Streptococcus agalactiae | 0 | 5 | 5 | 0 | 100 | N/A | 100 | 5 | 0 | 5 | 0 | 0 | 0  |
|  Penicillin | Streptococcus pyogenes | 0 | 6 | 6 | 0 | 100 | N/A | 100 | 6 | 0 | 6 | 0 | 0 | 0  |
|  |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Linezolid | Coagulase Negative Staph | 42 | 19 | 61 | 34 | 100 | 100 | 100 | 60 | 0 | 1 | 0 | 0 | 0  |
|  Linezolid | Enterococcus sp. | 40 | 16 | 56 | 48 | 100 | 100 | 100 | 51 | 0 | 5 | 0 | 0 | 0  |
|  Linezolid | Staphylococcus aureus | 62 | 27 | 89 | 88 | 100 | 100 | 100 | 89 | 0 | 0 | 0 | 0 | 0  |
|  Linezolid | Streptococcus agalactiae | 0 | 5 | 5 | 5 | 100 | 100 | 100 | 5 | 0 | 0 | 0 | 0 | 0  |
|  Linezolid | Streptococcus pyogenes | 0 | 6 | 6 | 6 | 100 | 100 | 100 | 6 | 0 | 0 | 0 | 0 | 0  |
|  |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Rifampin | Coagulase Negative Staph | 42 | 19 | 61 | 1 | 100 | 100 | 100 | 59 | 0 | 2 | 0 | 0 | 0  |
|  Rifampin | Enterococcus sp. | 40 | 16 | 56 | 29 | 100 | 100 | 85.7 | 23 | 17 | 16 | 0 | 0 | 8  |
|  Rifampin | Staphylococcus aureus | 62 | 27 | 89 | 1 | 100 | 100 | 100 | 87 | 0 | 2 | 0 | 0 | 0  |
|  |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Chloramphenicol | Coagulase Negative Staph | 42 | 19 | 61 | 57 | 98.4 | 100 | 100 | 58 | 0 | 3 | 0 | 0 | 0  |
|  Chloramphenicol | Enterococcus sp. | 40 | 16 | 56 | 46 | 100 | 100 | 94.6 | 43 | 4 | 9 | 0 | 0 | 3  |
|  Chloramphenicol | Staphylococcus aureus | 62 | 27 | 89 | 84 | 100 | 100 | 94.4 | 69 | 15 | 5 | 0 | 0 | 5  |
|  Chloramphenicol | Streptococcus agalactiae | 0 | 5 | 5 | 5 | 100 | 100 | 100 | 5 | 0 | 0 | 0 | 0 | 0  |
|  Chloramphenicol | Streptococcus pyogenes | 0 | 6 | 6 | 6 | 100 | 100 | 100 | 6 | 0 | 0 | 0 | 0 | 0  |
|  |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Clindamycin | Coagulase Negative Staph | 42 | 19 | 61 | 7 | 100 | 100 | 100 | 37 | 2 | 22 | 0 | 0 | 0  |
|  Clindamycin | Staphylococcus aureus | 62 | 27 | 89 | 3 | 100 | 100 | 100 | 72 | 0 | 17 | 0 | 0 | 0  |
|  Clindamycin | Streptococcus agalactiae | 0 | 5 | 5 | 0 | 100 | N/A | 100 | 5 | 0 | 0 | 0 | 0 | 0  |

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|  Drug | Organism Group | Clinical | Challenge | Total | Total Evaluable | %EA Total | % EA of Evaluable | %CA | S | I | R or NS | VMJ | MAJ | Minor  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  Clindamycin | Streptococcus pyogenes | 0 | 6 | 6 | 0 | 100 | N/A | 100 | 6 | 0 | 0 | 0 | 0 | 0  |
|  |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Tetracycline | Coagulase Negative Staph | 42 | 19 | 61 | 43 | 98.4 | 97.7 | 100 | 43 | 0 | 18 | 0 | 0 | 0  |
|  Tetracycline | Enterococcus sp. | 40 | 16 | 56 | 20 | 100 | 100 | 100 | 10 | 0 | 46 | 0 | 0 | 0  |
|  Tetracycline | Staphylococcus aureus | 62 | 27 | 89 | 78 | 100 | 100 | 100 | 77 | 0 | 12 | 0 | 0 | 0  |
|  Tetracycline | Streptococcus agalactiae | 0 | 5 | 5 | 4 | 100 | 100 | 100 | 1 | 0 | 4 | 0 | 0 | 0  |
|  Tetracycline | Streptococcus pyogenes | 0 | 6 | 6 | 5 | 100 | 100 | 100 | 5 | 0 | 1 | 0 | 0 | 0  |
|  |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Erythromycin | Coagulase Negative Staph | 42 | 19 | 61 | 7 | 98.4 | 85.7 | 98.4 | 24 | 1 | 36 | 0 | 0 | 1  |
|  Erythromycin | Enterococcus sp. | 40 | 16 | 56 | 18 | 100 | 100 | 100 | 9 | 13 | 34 | 0 | 0 | 0  |
|  Erythromycin | Staphylococcus aureus | 62 | 27 | 89 | 31 | 98.9 | 96.8 | 97.8 | 25 | 6 | 58 | 0 | 0 | 2  |
|  Erythromycin | Streptococcus agalactiae | 0 | 5 | 5 | 1 | 100 | 100 | 100 | 4 | 0 | 1 | 0 | 0 | 0  |
|  Erythromycin | Streptococcus pyogenes | 0 | 6 | 6 | 0 | 100 | N/A | 100 | 6 | 0 | 0 | 0 | 0 | 0  |
|  |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Ciprofloxacin | Coagulase Negative Staph | 42 | 19 | 61 | 32 | 100 | 100 | 100 | 31 | 0 | 30 | 0 | 0 | 0  |
|  Ciprofloxacin | Staphylococcus aureus | 62 | 27 | 89 | 61 | 100 | 100 | 100 | 55 | 4 | 30 | 0 | 0 | 0  |
|  |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Quinapristin/Dalfapristin | Coagulase Negative Staph | 42 | 19 | 61 | 0 | 100 | N/A | 100 | 61 | 0 | 0 | 0 | 0 | 0  |
|  Quinapristin/Dalfapristin | Enterococcus sp. | 40 | 16 | 56 | 32 | 100 | 100 | 100 | 17 | 3 | 36 | 0 | 0 | 0  |
|  Quinapristin/Dalfapristin | Staphylococcus aureus | 62 | 27 | 89 | 0 | 100 | N/A | 100 | 89 | 0 | 0 | 0 | 0 | 0  |
|  Quinapristin/Dalfapristin | Streptococcus pyogenes | 0 | 6 | 6 | 0 | 100 | N/A | 100 | 6 | 0 | 0 | 0 | 0 | 0  |
|  |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Daptomycin | Coagulase Negative Staph | 42 | 19 | 61 | 56 | 100 | 100 | 100 | 61 | 0 | 0 | 0 | 0 | 0  |
|  Daptomycin | Enterococcus sp. | 40 | 16 | 56 | 52 | 100 | 100 | 100 | 54 | 0 | 2 | 0 | 0 | 0  |
|  Daptomycin | Staphylococcus aureus | 62 | 27 | 89 | 86 | 100 | 100 | 100 | 89 | 0 | 0 | 0 | 0 | 0  |
|  Daptomycin | Streptococcus agalactiae | 0 | 5 | 5 | 5 | 100 | 100 | 100 | 5 | 0 | 0 | 0 | 0 | 0  |
|  Daptomycin | Streptococcus pyogenes | 0 | 6 | 6 | 0 | 100 | N/A | 100 | 6 | 0 | 0 | 0 | 0 | 0  |
|  |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Vancomycin | Coagulase Negative Staph | 42 | 19 | 61 | 54 | 100 | 100 | 100 | 61 | 0 | 0 | 0 | 0 | 0  |
|  Vancomycin | Enterococcus sp. | 40 | 16 | 56 | 27 | 100 | 100 | 100 | 28 | 3 | 25 | 0 | 0 | 0  |
|  Vancomycin | Staphylococcus aureus | 62 | 27 | 89 | 83 | 100 | 100 | 100 | 89 | 0 | 0 | 0 | 0 | 0  |
|  Vancomycin | Streptococcus agalactiae | 0 | 5 | 5 | 0 | 100 | N/A | 100 | 5 | 0 | 0 | 0 | 0 | 0  |

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|  Drug | Organism Group | Clinical | Challenge | Total | Total Evaluable | %EA Total | % EA of Evaluable | %CA | S | I | R or NS | VMJ | MAJ | Minor  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  Vancomycin | Streptococcus pyogenes | 0 | 6 | 6 | 0 | 100 | N/A | 100 | 6 | 0 | 0 | 0 | 0 | 0  |
|  |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Trimethoprim/Sulfamethoxazole | Coagulase Negative Staph | 42 | 19 | 61 | 2 | 100 | 100 | 100 | 36 | 0 | 25 | 0 | 0 | 0  |
|  Trimethoprim/Sulfamethoxazole | Staphylococcus aureus | 62 | 27 | 89 | 2 | 100 | 100 | 100 | 87 | 0 | 2 | 0 | 0 | 0  |
|  |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Gentamicin | Coagulase Negative Staph | 42 | 19 | 61 | 23 | 98.4 | 95.7 | 95.1 | 43 | 3 | 15 | 0 | 0 | 3  |
|  Gentamicin | Staphylococcus aureus | 62 | 27 | 89 | 80 | 98.9 | 98.8 | 100 | 85 | 0 | 4 | 0 | 0 | 0  |
|  |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Streptomycin-1000 ug/mL | Enterococcus sp. | 40 | 16 | 56 | 0 | 100 | N/A | 100 | 36 | 0 | 20 | 0 | 0 | 0  |
|  Clindamycin | Streptococcus pneumoniae | 60 | 24 | 84 | 48 | 98.8 | 97.9 | 98.8 | 48 | 0 | 36 | 0 | 0 | 1  |
|  Penicillin | Beta hemolytic strep | 27 | 0 | 27 | 7 | 100 | 100 | 100 | 27 | 0 | 0 | 0 | 0 | 0  |
|  Penicillin | Strep viridans | 46 | 25 | 71 | 49 | 100 | 100 | 97.2 | 46 | 17 | 8 | 0 | 0 | 2  |
|  Penicillin | Streptococcus agalactiae | 52 | 11 | 63 | 50 | 98.4 | 100 | 100 | 63 | 0 | 0 | 0 | 0 | 0  |
|  Penicillin | Streptococcus pneumoniae | 60 | 24 | 84 | 68 | 98.8 | 98.5 | 98.8 | 11 | 22 | 51 | 0 | 0 | 1  |
|  Penicillin | Streptococcus pyogenes | 53 | 14 | 67 | 0 | 100 | N/A | 100 | 67 | 0 | 0 | 0 | 0 | 0  |
|  |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Amoxicillin/Clavulanate | Streptococcus pneumoniae | 60 | 24 | 84 | 69 | 98.8 | 98.6 | 95.2 | 64 | 11 | 9 | 0 | 0 | 4  |
|  Linezolid | Beta hemolytic strep | 26 | 0 | 26 | 26 | 100 | 100 | 100 | 26 | 0 | 0 | 0 | 0 | 0  |
|  Linezolid | Streptococcus agalactiae | 53 | 11 | 64 | 64 | 100 | 100 | 100 | 64 | 0 | 0 | 0 | 0 | 0  |
|  Linezolid | Streptococcus pneumoniae | 60 | 24 | 84 | 84 | 100 | 100 | 100 | 84 | 0 | 0 | 0 | 0 | 0  |
|  Linezolid | Streptococcus pyogenes | 53 | 14 | 67 | 67 | 100 | 100 | 100 | 67 | 0 | 0 | 0 | 0 | 0  |
|  Linezolid | Streptococcus sp. | 47 | 25 | 72 | 72 | 100 | 100 | 100 | 72 | 0 | 0 | 0 | 0 | 0  |
|  |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Chloramphenicol | Beta hemolytic strep | 26 | 0 | 26 | 26 | 100 | 100 | 100 | 26 | 0 | 0 | 0 | 0 | 0  |
|  Chloramphenicol | Streptococcus agalactiae | 53 | 11 | 64 | 64 | 100 | 100 | 98.4 | 63 | 1 | 0 | 0 | 0 | 1  |
|  Chloramphenicol | Streptococcus pneumoniae | 60 | 24 | 84 | 55 | 100 | 100 | 100 | 55 | 0 | 29 | 0 | 0 | 0  |
|  Chloramphenicol | Streptococcus pyogenes | 53 | 14 | 67 | 67 | 100 | 100 | 100 | 67 | 0 | 0 | 0 | 0 | 0  |
|  Chloramphenicol | Streptococcus sp. | 47 | 25 | 72 | 67 | 100 | 100 | 100 | 72 | 0 | 0 | 0 | 0 | 0  |
|  |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Cefepime | Beta hemolytic strep | 27 | 0 | 27 | 27 | 100 | 100 | 100 | 27 | 0 | 0 | 0 | 0 | 0  |
|  Cefepime | Streptococcus agalactiae | 52 | 11 | 63 | 62 | 100 | 100 | 100 | 63 | 0 | 0 | 0 | 0 | 0  |
|  Cefepime | Streptococcus pneumoniae | 60 | 24 | 84 | 84 | 98.8 | 98.8 | 92.9 | 54 | 27 | 3 | 0 | 0 | 6  |

{13}

|  Drug | Organism Group | Clinical | Challenge | Total | Total Evaluable | %EA Total | % EA of Evaluable | %CA | S | I | R or NS | VMJ | MAJ | Minor  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  Cefepime | Streptococcus pyogenes | 53 | 14 | 67 | 26 | 98.5 | 100 | 100 | 67 | 0 | 0 | 0 | 0 | 0  |
|  |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Cefotaxime | Beta hemolytic strep | 27 | 0 | 27 | 18 | 96.3 | 94.4 | 100 | 27 | 0 | 0 | 0 | 0 | 0  |
|  Cefotaxime | Strep viridans | 46 | 25 | 71 | 62 | 98.6 | 98.4 | 97.2 | 63 | 4 | 4 | 0 | 0 | 2  |
|  Cefotaxime | Streptococcus agalactiae | 52 | 11 | 63 | 61 | 100 | 100 | 100 | 63 | 0 | 0 | 0 | 0 | 0  |
|  Cefotaxime | Streptococcus pneumoniae | 60 | 24 | 84 | 73 | 100 | 100 | 97.6 | 64 | 14 | 6 | 0 | 0 | 2  |
|  Cefotaxime | Streptococcus pyogenes | 53 | 14 | 67 | 2 | 100 | 100 | 100 | 67 | 0 | 0 | 0 | 0 | 0  |
|  |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Tetracycline | Beta hemolytic strep | 27 | 0 | 27 | 18 | 100 | 100 | 100 | 15 | 3 | 9 | 0 | 0 | 0  |
|  Tetracycline | Streptococcus agalactiae | 52 | 11 | 63 | 10 | 100 | 100 | 100 | 10 | 0 | 53 | 0 | 0 | 0  |
|  Tetracycline | Streptococcus pneumoniae | 60 | 24 | 84 | 35 | 100 | 100 | 98.8 | 35 | 0 | 49 | 0 | 0 | 1  |
|  Tetracycline | Streptococcus pyogenes | 53 | 14 | 67 | 57 | 98.5 | 98.2 | 100 | 56 | 1 | 10 | 0 | 0 | 0  |
|  Tetracycline | Streptococcus sp. | 47 | 25 | 72 | 51 | 100 | 100 | 97.2 | 49 | 2 | 21 | 0 | 0 | 2  |
|  |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Erythromycin | Beta hemolytic strep | 26 | 0 | 26 | 15 | 100 | 100 | 100 | 16 | 0 | 10 | 0 | 0 | 0  |
|  Erythromycin | Streptococcus agalactiae | 53 | 11 | 64 | 38 | 100 | 100 | 100 | 38 | 0 | 26 | 0 | 0 | 0  |
|  Erythromycin | Streptococcus pneumoniae | 60 | 24 | 84 | 40 | 100 | 100 | 98.8 | 39 | 1 | 44 | 0 | 0 | 1  |
|  Erythromycin | Streptococcus pyogenes | 53 | 14 | 67 | 58 | 100 | 100 | 100 | 58 | 0 | 9 | 0 | 0 | 0  |
|  Erythromycin | Streptococcus sp. | 47 | 25 | 72 | 33 | 100 | 100 | 100 | 29 | 0 | 43 | 0 | 0 | 0  |
|  |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Levofloxacin | Beta hemolytic strep | 26 | 0 | 26 | 24 | 100 | 100 | 100 | 26 | 0 | 0 | 0 | 0 | 0  |
|  Levofloxacin | Streptococcus agalactiae | 53 | 11 | 64 | 64 | 100 | 100 | 100 | 64 | 0 | 0 | 0 | 0 | 0  |
|  Levofloxacin | Streptococcus pneumoniae | 60 | 24 | 84 | 83 | 100 | 100 | 100 | 84 | 0 | 0 | 0 | 0 | 0  |
|  Levofloxacin | Streptococcus pyogenes | 53 | 14 | 67 | 66 | 100 | 100 | 100 | 66 | 1 | 0 | 0 | 0 | 0  |
|  Levofloxacin | Streptococcus sp. | 47 | 25 | 72 | 69 | 100 | 100 | 100 | 68 | 0 | 4 | 0 | 0 | 0  |
|  |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Meropenem | Beta hemolytic strep | 26 | 0 | 26 | 6 | 100 | 100 | 100 | 26 | 0 | 0 | 0 | 0 | 0  |
|  Meropenem | Streptococcus agalactiae | 53 | 11 | 64 | 49 | 100 | 100 | 100 | 64 | 0 | 0 | 0 | 0 | 0  |
|  Meropenem | Streptococcus pneumoniae | 60 | 24 | 84 | 64 | 100 | 100 | 97.6 | 35 | 26 | 23 | 0 | 0 | 2  |
|  Meropenem | Streptococcus pyogenes | 53 | 14 | 67 | 0 | 100 | N/A | 100 | 67 | 0 | 0 | 0 | 0 | 0  |
|  Meropenem | Streptococcus sp. | 47 | 25 | 72 | 34 | 100 | 100 | 100 | 65 | 0 | 7 | 0 | 0 | 0  |
|  |   |   |   |   |   |   |   |   |   |   |   |   |   |   |

{14}

|  Drug | Organism Group | Clinical | Challenge | Total | Total Evaluable | %EA Total | % EA of Evaluable | %CA | S | I | R or NS | VMJ | MAJ | Minor  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  Daptomycin | Beta hemolytic strep | 27 | 0 | 27 | 27 | 100 | 100 | 100 | 27 | 0 | 0 | 0 | 0 | 0  |
|  Daptomycin | Streptococcus agalactiae | 53 | 11 | 64 | 63 | 100 | 100 | 98.4 | 64 | 0 | 0 | 0 | 1 | 0  |
|  Daptomycin | Streptococcus pyogenes | 53 | 14 | 67 | 64 | 98.5 | 98.4 | 100 | 67 | 0 | 0 | 0 | 0 | 0  |
|  Daptomycin | Streptococcus sp. | 47 | 25 | 72 | 64 | 100 | 100 | 100 | 64 | 0 | 8 | 0 | 0 | 0  |
|  |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Vancomycin | Beta hemolytic strep | 26 | 0 | 26 | 26 | 96.2 | 96.2 | 100 | 26 | 0 | 0 | 0 | 0 | 0  |
|  Vancomycin | Streptococcus agalactiae | 53 | 11 | 64 | 64 | 100 | 100 | 100 | 64 | 0 | 0 | 0 | 0 | 0  |
|  Vancomycin | Streptococcus pneumoniae | 60 | 24 | 84 | 84 | 100 | 100 | 100 | 84 | 0 | 0 | 0 | 0 | 0  |
|  Vancomycin | Streptococcus pyogenes | 53 | 14 | 67 | 67 | 100 | 100 | 100 | 67 | 0 | 0 | 0 | 0 | 0  |
|  Vancomycin | Streptococcus sp. | 47 | 25 | 72 | 71 | 100 | 100 | 100 | 71 | 0 | 1 | 0 | 0 | 0  |
|  |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Trimethoprim/Sulfamethoxazole | Streptococcus pneumoniae | 60 | 24 | 84 | 35 | 100 | 100 | 96.4 | 20 | 17 | 47 | 0 | 0 | 3  |

{15}

Clinical and challenge isolate results summary for the AIM vs. Existing Autoinoculator (VIZION)

|  Drug | Organism Group | Clinical | Challenge | Total | Total Evaluable | %EA Total | % EA of Evaluable | %CA | S | I | R or NS | VMJ | MAJ | Minor  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  Oxacillin + 2% NaCl | Coagulase Negative Staph | 42 | 19 | 61 | 30 | 98.4 | 96.7 | 100 | 23 | 0 | 38 | 0 | 0 | 0  |
|  Oxacillin + 2% NaCl | Staphylococcus aureus | 62 | 27 | 89 | 55 | 100 | 100 | 100 | 47 | 0 | 42 | 0 | 0 | 0  |
|  |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Penicillin | Coagulase Negative Staph | 42 | 19 | 61 | 39 | 100 | 100 | 100 | 12 | 0 | 12 | 0 | 0 | 0  |
|  Penicillin | Enterococcus sp. | 40 | 16 | 56 | 41 | 100 | 100 | 100 | 41 | 0 | 41 | 0 | 0 | 0  |
|  Penicillin | Staphylococcus aureus | 62 | 27 | 89 | 30 | 100 | 100 | 100 | 12 | 0 | 12 | 0 | 0 | 0  |
|  Penicillin | Streptococcus agalactiae | 0 | 5 | 5 | 0 | 100 | N/A | 100 | 5 | 0 | 5 | 0 | 0 | 0  |
|  Penicillin | Streptococcus pyogenes | 0 | 6 | 6 | 0 | 100 | N/A | 100 | 6 | 0 | 6 | 0 | 0 | 0  |
|  |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Linezolid | Coagulase Negative Staph | 42 | 19 | 61 | 34 | 100 | 100 | 100 | 60 | 0 | 1 | 0 | 0 | 0  |
|  Linezolid | Enterococcus sp. | 40 | 16 | 56 | 48 | 100 | 100 | 100 | 51 | 0 | 5 | 0 | 0 | 0  |
|  Linezolid | Staphylococcus aureus | 62 | 27 | 89 | 88 | 100 | 100 | 100 | 89 | 0 | 0 | 0 | 0 | 0  |
|  Linezolid | Streptococcus agalactiae | 0 | 5 | 5 | 5 | 100 | 100 | 100 | 5 | 0 | 0 | 0 | 0 | 0  |
|  Linezolid | Streptococcus pyogenes | 0 | 6 | 6 | 6 | 100 | 100 | 100 | 6 | 0 | 0 | 0 | 0 | 0  |
|  |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Rifampin | Coagulase Negative Staph | 42 | 19 | 61 | 1 | 100 | 100 | 100 | 59 | 0 | 2 | 0 | 0 | 0  |
|  Rifampin | Enterococcus sp. | 40 | 16 | 56 | 29 | 100 | 100 | 85.7 | 23 | 17 | 16 | 0 | 0 | 8  |
|  Rifampin | Staphylococcus aureus | 62 | 27 | 89 | 1 | 100 | 100 | 100 | 87 | 0 | 2 | 0 | 0 | 0  |
|  |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Chloramphenicol | Coagulase Negative Staph | 42 | 19 | 61 | 57 | 98.4 | 100 | 100 | 58 | 0 | 3 | 0 | 0 | 0  |
|  Chloramphenicol | Enterococcus sp. | 40 | 16 | 56 | 46 | 100 | 100 | 94.6 | 43 | 4 | 9 | 0 | 0 | 3  |
|  Chloramphenicol | Staphylococcus aureus | 62 | 27 | 89 | 84 | 100 | 100 | 94.4 | 69 | 15 | 5 | 0 | 0 | 5  |
|  Chloramphenicol | Streptococcus agalactiae | 0 | 5 | 5 | 5 | 100 | 100 | 100 | 5 | 0 | 0 | 0 | 0 | 0  |
|  Chloramphenicol | Streptococcus pyogenes | 0 | 6 | 6 | 6 | 100 | 100 | 100 | 6 | 0 | 0 | 0 | 0 | 0  |
|  |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Clindamycin | Coagulase Negative Staph | 42 | 19 | 61 | 7 | 100 | 100 | 100 | 37 | 2 | 22 | 0 | 0 | 0  |
|  Clindamycin | Staphylococcus aureus | 62 | 27 | 89 | 3 | 100 | 100 | 100 | 72 | 0 | 17 | 0 | 0 | 0  |
|  Clindamycin | Streptococcus agalactiae | 0 | 5 | 5 | 0 | 100 | N/A | 100 | 5 | 0 | 0 | 0 | 0 | 0  |
|  Clindamycin | Streptococcus pyogenes | 0 | 6 | 6 | 0 | 100 | N/A | 100 | 6 | 0 | 0 | 0 | 0 | 0  |
|  |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Tetracycline | Coagulase Negative Staph | 42 | 19 | 61 | 43 | 98.4 | 97.7 | 100 | 43 | 0 | 18 | 0 | 0 | 0  |

{16}

|  Drug | Organism Group | Clinical | Challenge | Total | Total Evaluable | %EA Total | % EA of Evaluable | %CA | S | I | R or NS | VMJ | MAJ | Minor  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  Tetracycline | Enterococcus sp. | 40 | 16 | 56 | 20 | 100 | 100 | 100 | 10 | 0 | 46 | 0 | 0 | 0  |
|  Tetracycline | Staphylococcus aureus | 62 | 27 | 89 | 78 | 100 | 100 | 100 | 77 | 0 | 12 | 0 | 0 | 0  |
|  Tetracycline | Streptococcus agalactiae | 0 | 5 | 5 | 4 | 100 | 100 | 100 | 1 | 0 | 4 | 0 | 0 | 0  |
|  Tetracycline | Streptococcus pyogenes | 0 | 6 | 6 | 5 | 100 | 100 | 100 | 5 | 0 | 1 | 0 | 0 | 0  |
|  |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Erythromycin | Coagulase Negative Staph | 42 | 19 | 61 | 7 | 98.4 | 85.7 | 98.4 | 24 | 1 | 36 | 0 | 0 | 1  |
|  Erythromycin | Enterococcus sp. | 40 | 16 | 56 | 18 | 100 | 100 | 100 | 9 | 13 | 34 | 0 | 0 | 0  |
|  Erythromycin | Staphylococcus aureus | 62 | 27 | 89 | 31 | 98.9 | 96.8 | 97.8 | 25 | 6 | 58 | 0 | 0 | 2  |
|  Erythromycin | Streptococcus agalactiae | 0 | 5 | 5 | 1 | 100 | 100 | 100 | 4 | 0 | 1 | 0 | 0 | 0  |
|  Erythromycin | Streptococcus pyogenes | 0 | 6 | 6 | 0 | 100 | N/A | 100 | 6 | 0 | 0 | 0 | 0 | 0  |
|  |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Ciprofloxacin | Coagulase Negative Staph | 42 | 19 | 61 | 32 | 100 | 100 | 100 | 31 | 0 | 30 | 0 | 0 | 0  |
|  Ciprofloxacin | Staphylococcus aureus | 62 | 27 | 89 | 61 | 100 | 100 | 100 | 55 | 4 | 30 | 0 | 0 | 0  |
|  |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Quinapristin/Dalfapristin | Coagulase Negative Staph | 42 | 19 | 61 | 0 | 100 | N/A | 100 | 61 | 0 | 0 | 0 | 0 | 0  |
|  Quinapristin/Dalfapristin | Enterococcus sp. | 40 | 16 | 56 | 32 | 100 | 100 | 100 | 17 | 3 | 36 | 0 | 0 | 0  |
|  Quinapristin/Dalfapristin | Staphylococcus aureus | 62 | 27 | 89 | 0 | 100 | N/A | 100 | 89 | 0 | 0 | 0 | 0 | 0  |
|  Quinapristin/Dalfapristin | Streptococcus pyogenes | 0 | 6 | 6 | 0 | 100 | N/A | 100 | 6 | 0 | 0 | 0 | 0 | 0  |
|  |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Daptomycin | Coagulase Negative Staph | 42 | 19 | 61 | 56 | 100 | 100 | 100 | 61 | 0 | 0 | 0 | 0 | 0  |
|  Daptomycin | Enterococcus sp. | 40 | 16 | 56 | 52 | 100 | 100 | 100 | 54 | 0 | 2 | 0 | 0 | 0  |
|  Daptomycin | Staphylococcus aureus | 62 | 27 | 89 | 86 | 100 | 100 | 100 | 89 | 0 | 0 | 0 | 0 | 0  |
|  Daptomycin | Streptococcus agalactiae | 0 | 5 | 5 | 5 | 100 | 100 | 100 | 5 | 0 | 0 | 0 | 0 | 0  |
|  Daptomycin | Streptococcus pyogenes | 0 | 6 | 6 | 0 | 100 | N/A | 100 | 6 | 0 | 0 | 0 | 0 | 0  |
|  |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Vancomycin | Coagulase Negative Staph | 42 | 19 | 61 | 54 | 100 | 100 | 100 | 61 | 0 | 0 | 0 | 0 | 0  |
|  Vancomycin | Enterococcus sp. | 40 | 16 | 56 | 27 | 100 | 100 | 100 | 28 | 3 | 25 | 0 | 0 | 0  |
|  Vancomycin | Staphylococcus aureus | 62 | 27 | 89 | 83 | 100 | 100 | 100 | 89 | 0 | 0 | 0 | 0 | 0  |
|  Vancomycin | Streptococcus agalactiae | 0 | 5 | 5 | 0 | 100 | N/A | 100 | 5 | 0 | 0 | 0 | 0 | 0  |
|  Vancomycin | Streptococcus pyogenes | 0 | 6 | 6 | 0 | 100 | N/A | 100 | 6 | 0 | 0 | 0 | 0 | 0  |
|  |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Trimethoprim/Sulfamethoxazole | Coagulase Negative Staph | 42 | 19 | 61 | 2 | 100 | 100 | 100 | 36 | 0 | 25 | 0 | 0 | 0  |

{17}

|  Drug | Organism Group | Clinical | Challenge | Total | Total Evaluable | %EA Total | % EA of Evaluable | %CA | S | I | R or NS | VMJ | MAJ | Minor  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  Trimethoprim/Sulfamethoxazole | Staphylococcus aureus | 62 | 27 | 89 | 2 | 100 | 100 | 100 | 87 | 0 | 2 | 0 | 0 | 0  |
|  |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Gentamicin | Coagulase Negative Staph | 42 | 19 | 61 | 23 | 98.4 | 95.7 | 95.1 | 43 | 3 | 15 | 0 | 0 | 3  |
|  Gentamicin | Staphylococcus aureus | 62 | 27 | 89 | 80 | 98.9 | 98.8 | 100 | 85 | 0 | 4 | 0 | 0 | 0  |
|  |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Streptomycin-1000 ug/mL | Enterococcus sp. | 40 | 16 | 56 | 0 | 100 | N/A | 100 | 36 | 0 | 20 | 0 | 0 | 0  |
|  Clindamycin | Streptococcus pneumoniae | 60 | 24 | 84 | 48 | 98.8 | 97.9 | 98.8 | 48 | 0 | 36 | 0 | 0 | 1  |
|  Penicillin | Beta hemolytic strep | 27 | 0 | 27 | 7 | 100 | 100 | 100 | 27 | 0 | 0 | 0 | 0 | 0  |
|  Penicillin | Strep viridans | 46 | 25 | 71 | 49 | 100 | 100 | 97.2 | 46 | 17 | 8 | 0 | 0 | 2  |
|  Penicillin | Streptococcus agalactiae | 52 | 11 | 63 | 50 | 98.4 | 100 | 100 | 63 | 0 | 0 | 0 | 0 | 0  |
|  Penicillin | Streptococcus pneumoniae | 60 | 24 | 84 | 68 | 98.8 | 98.5 | 98.8 | 11 | 22 | 51 | 0 | 0 | 1  |
|  Penicillin | Streptococcus pyogenes | 53 | 14 | 67 | 0 | 100 | N/A | 100 | 67 | 0 | 0 | 0 | 0 | 0  |
|  |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Amoxicillin/Clavulanate | Streptococcus pneumoniae | 60 | 24 | 84 | 69 | 98.8 | 98.6 | 95.2 | 64 | 11 | 9 | 0 | 0 | 4  |
|  Linezolid | Beta hemolytic strep | 26 | 0 | 26 | 26 | 100 | 100 | 100 | 26 | 0 | 0 | 0 | 0 | 0  |
|  Linezolid | Streptococcus agalactiae | 53 | 11 | 64 | 64 | 100 | 100 | 100 | 64 | 0 | 0 | 0 | 0 | 0  |
|  Linezolid | Streptococcus pneumoniae | 60 | 24 | 84 | 84 | 100 | 100 | 100 | 84 | 0 | 0 | 0 | 0 | 0  |
|  Linezolid | Streptococcus pyogenes | 53 | 14 | 67 | 67 | 100 | 100 | 100 | 67 | 0 | 0 | 0 | 0 | 0  |
|  Linezolid | Streptococcus sp. | 47 | 25 | 72 | 72 | 100 | 100 | 100 | 72 | 0 | 0 | 0 | 0 | 0  |
|  |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Chloramphenicol | Beta hemolytic strep | 26 | 0 | 26 | 26 | 100 | 100 | 100 | 26 | 0 | 0 | 0 | 0 | 0  |
|  Chloramphenicol | Streptococcus agalactiae | 53 | 11 | 64 | 64 | 100 | 100 | 98.4 | 63 | 1 | 0 | 0 | 0 | 1  |
|  Chloramphenicol | Streptococcus pneumoniae | 60 | 24 | 84 | 55 | 100 | 100 | 100 | 55 | 0 | 29 | 0 | 0 | 0  |
|  Chloramphenicol | Streptococcus pyogenes | 53 | 14 | 67 | 67 | 100 | 100 | 100 | 67 | 0 | 0 | 0 | 0 | 0  |
|  Chloramphenicol | Streptococcus sp. | 47 | 25 | 72 | 67 | 100 | 100 | 100 | 72 | 0 | 0 | 0 | 0 | 0  |
|  |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Cefepime | Beta hemolytic strep | 27 | 0 | 27 | 27 | 100 | 100 | 100 | 27 | 0 | 0 | 0 | 0 | 0  |
|  Cefepime | Streptococcus agalactiae | 52 | 11 | 63 | 62 | 100 | 100 | 100 | 63 | 0 | 0 | 0 | 0 | 0  |
|  Cefepime | Streptococcus pneumoniae | 60 | 24 | 84 | 84 | 98.8 | 98.8 | 92.9 | 54 | 27 | 3 | 0 | 0 | 6  |
|  Cefepime | Streptococcus pyogenes | 53 | 14 | 67 | 26 | 98.5 | 100 | 100 | 67 | 0 | 0 | 0 | 0 | 0  |
|  |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Cefotaxime | Beta hemolytic strep | 27 | 0 | 27 | 18 | 96.3 | 94.4 | 100 | 27 | 0 | 0 | 0 | 0 | 0  |

{18}

|  Drug | Organism Group | Clinical | Challenge | Total | Total Evaluable | %EA Total | % EA of Evaluable | %CA | S | I | R or NS | VMJ | MAJ | Minor  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  Cefotaxime | Strep viridans | 46 | 25 | 71 | 62 | 98.6 | 98.4 | 97.2 | 63 | 4 | 4 | 0 | 0 | 2  |
|  Cefotaxime | Streptococcus agalactiae | 52 | 11 | 63 | 61 | 100 | 100 | 100 | 63 | 0 | 0 | 0 | 0 | 0  |
|  Cefotaxime | Streptococcus pneumoniae | 60 | 24 | 84 | 73 | 100 | 100 | 97.6 | 64 | 14 | 6 | 0 | 0 | 2  |
|  Cefotaxime | Streptococcus pyogenes | 53 | 14 | 67 | 2 | 100 | 100 | 100 | 67 | 0 | 0 | 0 | 0 | 0  |
|  |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Tetracycline | Beta hemolytic strep | 27 | 0 | 27 | 18 | 100 | 100 | 100 | 15 | 3 | 9 | 0 | 0 | 0  |
|  Tetracycline | Streptococcus agalactiae | 52 | 11 | 63 | 10 | 100 | 100 | 100 | 10 | 0 | 53 | 0 | 0 | 0  |
|  Tetracycline | Streptococcus pneumoniae | 60 | 24 | 84 | 35 | 100 | 100 | 98.8 | 35 | 0 | 49 | 0 | 0 | 1  |
|  Tetracycline | Streptococcus pyogenes | 53 | 14 | 67 | 57 | 98.5 | 98.2 | 100 | 56 | 1 | 10 | 0 | 0 | 0  |
|  Tetracycline | Streptococcus sp. | 47 | 25 | 72 | 51 | 100 | 100 | 97.2 | 49 | 2 | 21 | 0 | 0 | 2  |
|  |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Erythromycin | Beta hemolytic strep | 26 | 0 | 26 | 15 | 100 | 100 | 100 | 16 | 0 | 10 | 0 | 0 | 0  |
|  Erythromycin | Streptococcus agalactiae | 53 | 11 | 64 | 38 | 100 | 100 | 100 | 38 | 0 | 26 | 0 | 0 | 0  |
|  Erythromycin | Streptococcus pneumoniae | 60 | 24 | 84 | 40 | 100 | 100 | 98.8 | 39 | 1 | 44 | 0 | 0 | 1  |
|  Erythromycin | Streptococcus pyogenes | 53 | 14 | 67 | 58 | 100 | 100 | 100 | 58 | 0 | 9 | 0 | 0 | 0  |
|  Erythromycin | Streptococcus sp. | 47 | 25 | 72 | 33 | 100 | 100 | 100 | 29 | 0 | 43 | 0 | 0 | 0  |
|  |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Levofloxacin | Beta hemolytic strep | 26 | 0 | 26 | 24 | 100 | 100 | 100 | 26 | 0 | 0 | 0 | 0 | 0  |
|  Levofloxacin | Streptococcus agalactiae | 53 | 11 | 64 | 64 | 100 | 100 | 100 | 64 | 0 | 0 | 0 | 0 | 0  |
|  Levofloxacin | Streptococcus pneumoniae | 60 | 24 | 84 | 83 | 100 | 100 | 100 | 84 | 0 | 0 | 0 | 0 | 0  |
|  Levofloxacin | Streptococcus pyogenes | 53 | 14 | 67 | 66 | 100 | 100 | 100 | 66 | 1 | 0 | 0 | 0 | 0  |
|  Levofloxacin | Streptococcus sp. | 47 | 25 | 72 | 69 | 100 | 100 | 100 | 68 | 0 | 4 | 0 | 0 | 0  |
|  |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Meropenem | Beta hemolytic strep | 26 | 0 | 26 | 6 | 100 | 100 | 100 | 26 | 0 | 0 | 0 | 0 | 0  |
|  Meropenem | Streptococcus agalactiae | 53 | 11 | 64 | 49 | 100 | 100 | 100 | 64 | 0 | 0 | 0 | 0 | 0  |
|  Meropenem | Streptococcus pneumoniae | 60 | 24 | 84 | 64 | 100 | 100 | 97.6 | 35 | 26 | 23 | 0 | 0 | 2  |
|  Meropenem | Streptococcus pyogenes | 53 | 14 | 67 | 0 | 100 | N/A | 100 | 67 | 0 | 0 | 0 | 0 | 0  |
|  Meropenem | Streptococcus sp. | 47 | 25 | 72 | 34 | 100 | 100 | 100 | 65 | 0 | 7 | 0 | 0 | 0  |
|  |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Daptomycin | Beta hemolytic strep | 27 | 0 | 27 | 27 | 100 | 100 | 100 | 27 | 0 | 0 | 0 | 0 | 0  |
|  Daptomycin | Streptococcus agalactiae | 53 | 11 | 64 | 63 | 100 | 100 | 98.4 | 64 | 0 | 0 | 0 | 1 | 0  |
|  Daptomycin | Streptococcus pyogenes | 53 | 14 | 67 | 64 | 98.5 | 98.4 | 100 | 67 | 0 | 0 | 0 | 0 | 0  |

{19}

|  Drug | Organism Group | Clinical | Challenge | Total | Total Evaluable | %EA Total | % EA of Evaluable | %CA | S | I | R or NS | VMJ | MAJ | Minor  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  Daptomycin | Streptococcus sp. | 47 | 25 | 72 | 64 | 100 | 100 | 100 | 64 | 0 | 8 | 0 | 0 | 0  |
|  |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Vancomycin | Beta hemolytic strep | 26 | 0 | 26 | 26 | 96.2 | 96.2 | 100 | 26 | 0 | 0 | 0 | 0 | 0  |
|  Vancomycin | Streptococcus agalactiae | 53 | 11 | 64 | 64 | 100 | 100 | 100 | 64 | 0 | 0 | 0 | 0 | 0  |
|  Vancomycin | Streptococcus pneumoniae | 60 | 24 | 84 | 84 | 100 | 100 | 100 | 84 | 0 | 0 | 0 | 0 | 0  |
|  Vancomycin | Streptococcus pyogenes | 53 | 14 | 67 | 67 | 100 | 100 | 100 | 67 | 0 | 0 | 0 | 0 | 0  |
|  Vancomycin | Streptococcus sp. | 47 | 25 | 72 | 71 | 100 | 100 | 100 | 71 | 0 | 1 | 0 | 0 | 0  |
|  |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Trimethoprim/Sulfamethoxazole | Streptococcus pneumoniae | 60 | 24 | 84 | 35 | 100 | 100 | 96.4 | 20 | 17 | 47 | 0 | 0 | 3  |

Clinical and challenge isolate results summary for the AIM vs. Existing Autoinoculator (VIZION-Site 3)

|  Drug | Organism Group | Clinical | Challenge | Total | Total Evaluable | %EA Total | % EA of Evaluable | %CA | S | I | R or NS | VMJ | MAJ | Minor  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  Ampicillin | H. influenzae | 46 | 0 | 46 | 11 | 69.6 | 90.9 | 71.7 | 26 | 0 | 20 | 7 | 5 | 1  |
|  Amoxacillin/Clavulanate |   | 46 | 0 | 46 | 1 | 100 | 100 | 100 | 46 | 0 | 0 | 0 | 0 | 0  |
|  Ampicillin/Sulbactam |   | 46 | 0 | 46 | 3 | 100 | 100 | 95.7 | 43 | 0 | 3 | 1 | 1 | 0  |
|  Chloramphenicol |   | 46 | 0 | 46 | 7 | 97.8 | 100 | 97.8 | 46 | 0 | 0 | 0 | 1 | 0  |
|  Cefaclor |   | 46 | 0 | 46 | 7 | 100 | 100 | 84.8 | 39 | 5 | 2 | 0 | 2 | 5  |
|  Cefepime |   | 46 | 0 | 46 | 0 | 97.8 | N/A | 100 | 46 | 0 | 0 | 0 | 0 | 0  |
|  Cefexime |   | 46 | 0 | 46 | 0 | 97.8 | N/A | 100 | 46 | 0 | 0 | 0 | 0 | 0  |
|  Ceftriaxone |   | 46 | 0 | 46 | 0 | 89.1 | N/A | 93.5 | 39 | 0 | 7 | 2 | 1 | 0  |
|  Cefuroxime (sodium) |   | 46 | 0 | 46 | 11 | 89.1 | 100 | 100 | 46 | 0 | 0 | 0 | 0 | 0  |
|  Tetracycline |   | 46 | 0 | 46 | 32 | 87 | 96.9 | 91.3 | 44 | 0 | 2 | 2 | 0 | 2  |
|  Clarithromycin |   | 46 | 0 | 46 | 25 | 87 | 80 | 69.6 | 21 | 8 | 17 | 3 | 1 | 10  |
|  Imipenem |   | 46 | 0 | 46 | 1 | 97.8 | 100 | 97.8 | 45 | 0 | 1 | 1 | 0 | 0  |
|  Meropenem |   | 46 | 0 | 46 | 1 | 93.5 | 100 | 95.7 | 44 | 0 | 2 | 2 | 0 | 0  |
|  Trimethoprim/Sulfamethoxazole |   | 46 | 0 | 46 | 9 | 76.1 | 77.8 | 76.1 | 28 | 4 | 14 | 4 | 1 | 6  |

{20}

Clinical and challenge isolate results summary for the AIM vs. Existing Autoinoculator (VIZION-Sites 1, 2 and 4)*

|  Drug | Organism Group | Clinical | Challenge | Total | Total Evaluable | %EA Total | % EA of Evaluable | %CA | S | I | R or NS | VMJ | MAJ | Minor  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  Ampicillin | H. influenzae | 150 | 49 | 199 | 89 | 100 | 100 | 98.9 | 127 | 9 | 63 | 0 | 0 | 2  |
|  Amoxacillin/Clavulanate |   | 150 | 49 | 199 | 30 | 99.5 | 100 | 99.5 | 169 | 3 | 27 | 0 | 0 | 1  |
|  Ampicillin/Sulbactam |   | 150 | 49 | 199 | 31 | 100 | 100 | 99.5 | 169 | 0 | 30 | 0 | 1 | 0  |
|  Chloramphenicol |   | 150 | 49 | 199 | 46 | 100 | 100 | 99.5 | 188 | 2 | 9 | 0 | 0 | 1  |
|  Cefaclor |   | 150 | 49 | 199 | 31 | 100 | 100 | 97.5 | 179 | 6 | 14 | 0 | 0 | 5  |
|  Cefepime |   | 150 | 49 | 199 | 13 | 100 | 100 | 100 | 187 | 0 | 12 | 0 | 0 | 0  |
|  Cefexime |   | 150 | 49 | 199 | 8 | 100 | 100 | 100 | 188 | 0 | 11 | 0 | 0 | 0  |
|  Ceftriaxone |   | 150 | 49 | 199 | 7 | 100 | 100 | 100 | 190 | 0 | 9 | 0 | 0 | 0  |
|  Cefuroxime (sodium) |   | 150 | 49 | 199 | 101 | 100 | 100 | 100 | 188 | 2 | 9 | 0 | 0 | 0  |
|  Tetracycline |   | 150 | 49 | 199 | 186 | 99.5 | 100 | 100 | 196 | 0 | 3 | 0 | 0 | 0  |
|  Clarithromycin |   | 150 | 49 | 199 | 185 | 100 | 100 | 96.9 | 124 | 63 | 12 | 0 | 0 | 6  |
|  Imipenem |   | 150 | 49 | 199 | 30 | 100 | 100 | 100 | 190 | 0 | 9 | 0 | 0 | 0  |
|  Meropenem |   | 150 | 49 | 199 | 24 | 100 | 100 | 100 | 186 | 0 | 13 | 0 | 0 | 0  |
|  Trimethoprim/Sulfamethoxazole |   | 150 | 49 | 199 | 104 | 100 | 100 | 99.5 | 137 | 18 | 44 | 0 | 0 | 1  |

* Studies with H. influenzae were conducted at 2 external and one internal site. Forty-six H. influenzae isolates, which were originally tested at one of the external sites (site 3), showed unacceptable major error rates (i.e. 3.6 to 19%) and very major error rates (i.e. 17.5 to 100%) with the use of the VIZION for the following drugs: Ampicillin, Chloramphenicol, Cefaclor, Ceftriaxone, Tetracycline, Clarithromycin, Imipenem, Meropenem, and TMP/SMX. This was attributed to site-specific issues of failure to follow on-site training along with failure to confirm the VIZION readings on a mirror viewer. These 46 isolates were later sent to another external laboratory (site 4) for retesting using the VIZION. Site 4 tested the same 46 clinical isolates as site 3 as per the TL. The results presented in this table (3C) reflect the overall results from sites 1, 2 and 4. Please refer to the limitations section.

The following limitation will be included in labeling: "Major and very major errors have occurred when reading H. influenzae results on the VIZION. When using the AIM to inoculate H. influenzae, results obtained by reading on the VIZION should be confirmed with the mirrored viewer."

{21}

Clinical and challenge isolate results summary for the AIM vs. existing Autoinoculator for Cefoxitin Screen Test and Dtest (AutoReader/VIZION)

|  Cefoxitin Screen-S. aureus | Total | # CA | % CA | #R | # VMJ | %VMJ | #S | #MAJ | %MAJ  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  AutoReader | 89 | 86 | 96.6 | 41 | 1 | 2.4 | 48 | 2 | 4.2  |
|  VIZION | 88 | 87 | 98.9 | 42 | 0 | 0.0 | 46 | 1 | 2.2  |
|  |   |   |   |   |   |   |   |   |   |
|  Dtest S. aureus | Total | # CA | % CA | #R | # VMJ | %VMJ | #S | #MAJ | %MAJ  |
|  AutoReader | 89 | 87 | 97.8 | 42 | 1 | 2.4 | 47 | 1 | 2.1  |
|  VIZION | 88 | 87 | 98.9 | 42 | 1 | 2.4 | 46 | 0 | 0.0  |
|  |   |   |   |   |   |   |   |   |   |
|  Dtest Coagulase Negative Staphylococci | Total | # CA | % CA | #R | # VMJ | %VMJ | #S | #MAJ | %MAJ  |
|  AutoReader | 61 | 61 | 100.0 | 30 | 0 | 0.0 | 31 | 0 | 0.0  |
|  VIZION | 61 | 61 | 100.0 | 30 | 0 | 0.0 | 31 | 0 | 0.0  |

The following limitation will be included in labeling: "One major and one very major error occurred when reading S. aureus results on the AutoReader and the VIZION. When using the AIM to inoculate S. aureus for Dtest, consider alternative inoculation methods if inducible clindamycin resistance is suspected."

22

{22}

Clinical and challenge isolate results summary for the AIM vs. existing Autoinoculator (Mirror Read)

|  Drug | Organism Group | Clinical | Challenge | Total | Total Evaluable | %EA Total | % EA of Evaluable | %CA | S | I | R or NS | VMJ | MAJ | Minor  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  5-Flucytocine | C. albicans | 48 | 13 | 61 | 51 | 100 | 100 | 100 | 61 | 0 | 0 | 0 | 0 | 0  |
|   | C. glabrata | 17 | 24 | 41 | 1 | 100 | 100 | 100 | 41 | 0 | 0 | 0 | 0 | 0  |
|   | C. krusei | 57 | 7 | 64 | 64 | 100 | 100 | 96.9 | 12 | 52 | 0 | 0 | 0 | 2  |
|   | C. lusitinae | 15 | 5 | 20 | 1 | 100 | 100 | 100 | 20 | 0 | 0 | 0 | 0 | 0  |
|   | C. parapsilosis | 58 | 10 | 68 | 58 | 100 | 100 | 100 | 66 | 0 | 2 | 0 | 0 | 0  |
|   | C. tropicalis | 33 | 16 | 49 | 32 | 100 | 100 | 100 | 39 | 0 | 10 | 0 | 0 | 0  |
|  |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Itraconazole | C. albicans | 48 | 13 | 61 | 57 | 100 | 100 | 96.7 | 50 | 8 | 3 | 0 | 0 | 2  |
|  |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Fluconazole | C. albicans | 48 | 13 | 61 | 59 | 100 | 100 | 100 | 59 | 1 | 1 | 0 | 0 | 0  |
|   | C. glabrata | 17 | 24 | 41 | 41 | 100 | 100 | 95.1 | 16 | 15 | 10 | 0 | 0 | 2  |
|   | C. krusei | 57 | 7 | 64 | 64 | 100 | 100 | 100 | 3 | 27 | 34 | 0 | 0 | 0  |
|   | C. lusitinae | 15 | 5 | 20 | 17 | 100 | 100 | 100 | 20 | 0 | 0 | 0 | 0 | 0  |
|   | C. parapsilosis | 58 | 10 | 68 | 67 | 100 | 100 | 100 | 66 | 2 | 0 | 0 | 0 | 0  |
|   | C. tropicalis | 33 | 16 | 49 | 47 | 100 | 100 | 100 | 46 | 1 | 2 | 0 | 0 | 0  |
|  |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Voriconazole | C. albicans | 48 | 13 | 61 | 12 | 100 | 100 | 100 | 60 | 1 | 0 | 0 | 0 | 0  |
|   | C. glabrata | 17 | 24 | 41 | 40 | 97.6 | 100 | 100 | 37 | 2 | 2 | 0 | 0 | 0  |
|   | C. krusei | 57 | 7 | 64 | 63 | 100 | 100 | 100 | 63 | 0 | 1 | 0 | 0 | 0  |
|   | C. lusitinae | 15 | 5 | 20 | 5 | 100 | 100 | 100 | 20 | 0 | 0 | 0 | 0 | 0  |
|   | C. parapsilosis | 58 | 10 | 68 | 55 | 100 | 100 | 100 | 68 | 0 | 0 | 0 | 0 | 0  |
|   | C. tropicalis | 33 | 16 | 49 | 45 | 100 | 100 | 98 | 47 | 0 | 2 | 0 | 0 | 1  |

{23}

Essential agreement (EA) is when the Sensititre panels inoculated with the AIM produced MIC results that are within +/- one doubling dilution of the results obtained from the Sensititre panels inoculated with Autoinoculator I. Category agreement (CA) is when the Sensititre panel inoculated with the AIM produced interpretative results (SIR) that agreed exactly with those of the Autoinoculator I.

The percent EA is acceptable when compared to the reference method as described in the FDA guidance document, "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA".

Overall, results for all the drugs evaluated were comparable whether the inoculation method was with the existing Autoinoculator I or with the AIM. As shown in the table below, the EA and CA rates were greater than 90% for each group of organisms for all drugs combined.

|  Organism/Group | Number of isolates tested | EA (%) | CA (%)  |
| --- | --- | --- | --- |
|   | AutoReader  |   |   |
|  S. aureus | 89 | 99.8 | 99.4  |
|  Staphylococcus spp. (CNS) | 61 | 99.4 | 99.5  |
|  Enterococcus spp. | 56 | 100 | 98.2  |
|  Beta hemolytic Streptococcus spp.(MHB) | 11 | 100 | 100  |
|  S. pneumoniae | 84 | 99.2 | 97.7  |
|  Viridans Streptococcus spp. | 72 | 99.8 | 99.1  |
|  Beta hemolytic group Streptococcus spp. (LHB) | 157 | 99.7 | 99.8  |
|   | VIZION  |   |   |
|  S. aureus | 88 | 99.9 | 99.2  |
|  Staphylococcus spp. (CNS) | 63 | 99.9 | 99.3  |
|  Enterococcus spp. | 57 | 100 | 98.9  |
|  Beta hemolytic Streptococcus spp.(MHB) | 12 | 100 | 100  |
|  S. pneumoniae | 89 | 99.6 | 97.5  |
|  Viridans Streptococcus spp. | 72 | 99.3 | 98.4  |
|  Beta hemolytic group Streptococcus spp. (LHB) | 156 | 99.8 | 100  |
|  |   |   |   |
|  Haemophilus influenzae | 195 | 99.5 | 99.2  |
|   | Manual Mirror  |   |   |
|  Candida spp | 303 | 99.9% | 99.2%  |

*MHB= Mueller-Hinton Broth
*LHB = Lysed Horse Blood added to MHB

b. Matrix comparison:

Not Applicable

{24}

3. Clinical Studies:

a. Clinical Sensitivity:
Not Applicable

b. Clinical specificity:
Not Applicable

c. Other clinical supportive data (when a. and b. are not applicable):
Not Applicable

4. Clinical cut-off:
Not Applicable

5. Expected values/Reference range:
Not applicable.

N. Instrument Name:
Sensititre® AIM™

O. System Descriptions:

1. Modes of Operation:

The Autoinoculator 2/AIM is a bench-top instrument which dispenses bacterial suspension (inoculum) into the Sensititre 96-well plate. The instrument has a display which presents options to the End User graphically. After making a selection of the panel layout/configuration, the user may then select the well dose volume (a multiple of 50 µl) specific to each panel section (note that different panel sections may be dosed differently). Having selected these parameters, the user loads the sample, loads a suitable plate and then starts the dosing cycle.

The Autoinoculator 2/AIM is a stand-alone device and requires no connections to other equipment in normal use. It currently provides no support for sample tracking.

2. Software:

FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types:

25

{25}

Yes ☐ X ☐ or No ☐

3. Specimen Identification:

The specimen is identified manually by the user. The AIM instrument provides no support for sample tracking.

4. Specimen Sampling and Handling:

The bacterial suspension (inoculum) is prepared by the user. A Sensititre disposable dosehead is affixed to the glass tube containing the final inoculum density which is placed into the instrument's pump assembly. The AIM instrument then dispenses the inoculum into the Sensititre 96-well plate.

5. Calibration:

The AIM instrument is calibrated by weighing inoculated plates. It is recommended that calibration should be carried out at intervals of no less than 1 year.

6. Quality Control:

The AIM instrument uses a built-in routine allowing the adjustment and calibration of the plate dosing. The QC is performed by measuring the weight of a panel before and after dosing, to establish the weight and thus volume of the dosing droplets.

P. Other Supportive Instrument Performance Characteristics Data Not Covered In The "Performance Characteristics" Section above:

Not applicable. All instrument data is included above in section M.

Q. Proposed Labeling:

The labeling is sufficient and satisfies the requirements of 21 CFR Part 809.10.

R. Conclusion:

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

26

---

**Source:** [https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LIE/K103456](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LIE/K103456)

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