ASTar BC G- Kit and ASTar Instrument

K221688 · Q-Linea AB · SAN · Apr 26, 2024 · Microbiology

Device Facts

• Record ID: K221688
• Device Name: ASTar BC G- Kit and ASTar Instrument
• Applicant: Q-Linea AB
• Product Code: SAN · Microbiology
• Decision Date: Apr 26, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1650
• Device Class: Class 2
• Attributes: AI/ML

Intended Use

The ASTar System is intended to be used for the automated quantitative susceptibility testing for most clinically significant microorganisms. The ASTar System does not provide organism identification.

Device Story

The ASTar System performs automated antimicrobial susceptibility testing (AST) on positive blood culture samples. The operator loads approximately 1 mL of a Gram-stained, positive blood culture sample into an ASTar Cartridge. The instrument purifies the sample, adjusts the bacterial concentration to a standardized inoculum, and transfers it to an ASTar Disc. The system uses high-speed, time-lapse microscopy to monitor bacterial growth in the presence of various antimicrobial concentrations. The instrument processes up to six samples in parallel and can incubate up to 12 discs simultaneously. Results, including Minimum Inhibitory Concentration (MIC) and qualitative susceptibility (S, I, R), are generated within approximately six hours. The system requires external organism identification to report results. Healthcare providers use these results to guide antimicrobial therapy for patients with suspected bacteremia. The system benefits patients by providing rapid, quantitative susceptibility data, potentially enabling faster optimization of antibiotic treatment.

Clinical Evidence

Clinical study evaluated 933 valid samples (256 fresh positive blood cultures, 223 contrived with clinical stock, 401 contrived with challenge isolates). Performance compared to frozen BMD (CLSI M07). Overall Essential Agreement (EA) and Category Agreement (CA) were calculated for 18 antimicrobials across various Gram-negative species. Results showed high performance across most antimicrobials, with EA and CA generally meeting acceptance criteria. 97.2% of samples produced at least partial AST results. Reproducibility studies (n=23 strains) demonstrated ≥95% reproducibility for best-case scenarios.

Technological Characteristics

The system uses high-speed, time-lapse microscopy for optical detection of bacterial growth in broth microdilution. It consists of the ASTar Instrument, ASTar Cartridge (sample prep), and ASTar Disc (incubation/imaging). It is a fully automated, networked system. Software performs image analysis to determine MICs. The system is designed for use with positive blood culture bottles (e.g., BD BACTEC, bioMérieux BACT/ALERT).

Indications for Use

Indicated for in vitro, quantitative determination of antimicrobial susceptibility of on-panel gram-negative bacteria from positive blood culture samples confirmed by Gram stain. Requires organism identification from an approved method for result interpretation. For prescription use only.

Regulatory Classification

Identification

A cellular analysis system for multiplexed antimicrobial susceptibility testing is a multiplex qualitative and/or quantitative in vitro diagnostic device intended for the identification and determination of the antimicrobial susceptibility results of organisms detected in samples from patients with suspected microbial infections. This device is intended to aid in the determination of antimicrobial susceptibility or resistance when used in conjunction with other laboratory findings.

Special Controls

*Classification.* Class II (special controls). The special controls for this device are:(1) Design verification and validation must include: (i) Detailed device description documentation, including the device components, ancillary reagents required but not provided, a detailed explanation of the methodology, including primer/probe sequence, design, rationale for sequence selection, and details of the antimicrobial agents, as applicable. (ii) Detailed documentation from the following analytical and clinical performance studies: limit of detection, inclusivity, precision, reproducibility, interference, cross-reactivity, carryover, and cross-contamination, quality control and additional studies, as applicable to specimen type and assay intended use. (iii) Detailed documentation from an appropriate clinical study. The study, performed on a study population consistent with the intended use population, must compare the device performance to results obtained from well-accepted reference methods. (iv) Detailed documentation for device software, including software applications and hardware-based devices that incorporate software. (2) The labeling required under § 809.10(b) of this chapter must include: (i) Limitations and protocols regarding the need for correlation of results by standard laboratory procedures, as applicable. (ii) A detailed explanation of the interpretation of results and acceptance criteria. (iii) A detailed explanation of the principles of operation and procedures for assay performance and troubleshooting.

Predicate Devices

• Accelerate PhenoTest BC Kit (DEN160032)

Submission Summary (Full Text)

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

April 26, 2024

Q-linea AB % Peter Trabold Regulatory Affairs Specialist MDC Associates, Inc. 48 Dunham Ridge Road Suite 4000 Beverly, Massachusetts 01915

Re: K221688

Trade/Device Name: ASTar BC G- Kit and ASTar Instrument Regulation Number: 21 CFR 866.1650 Regulation Name: A Cellular Analysis System For Multiplexed Antimicrobial Susceptibility Testing Regulatory Class: Class II Product Code: SAN, LON Dated: November 15, 2023 Received: November 15, 2023

Dear Peter Trabold:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Natasha Griffin -S

o.b.o. Ribhi Shawar, Ph.D. (ABMM) Branch Chief General Bacteriology and Antimicrobial Susceptibility Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

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## Indications for Use

510(k) Number (if known) K221688

Device Name ASTar BC G- Kit and ASTar Instrument

#### Indications for Use (Describe)

Intended Use:

The ASTar System is intended to be used for the automated quantitative susceptibility testing for most clinically significant microorganisms. The ASTar System does not provide organism identification.

#### Indications for Use:

The ASTar System, comprised of the ASTar Instrument with the ASTar BC G- Consumable kit, ASTar BC G-Frozen insert, and ASTar BC G-Kit software), utilizes high-speed, time-lapse microscopy imaging of bacteria for the in vitro, quantitative determination of antimicrobial susceptibility of on-panel gram-negative bacteria. The test is performed directly on positive blood culture samples signaled as positive by a continuous monitoring blood culture system and confirmed to contain gram-negative bacilli by Gram stain. Organism identification is required for AST result interpretation and reporting.

Test results from the ASTar BC G-Kit should be interpreted in conjunction with other clinical and laboratory findings. Standard laboratory protocols for processing positive blood cultures should be followed to ensure availability of isolates for supplemental testing. Sub-culturing is necessary to support further testing for: bacteria and antimicrobials not on the ASTar BC G- panel, where inconclusive results are obtained, epidemiologic testing, recovery of organisms present in microbial samples, and susceptibility testing of bacteria in polymicrobial samples.

The ASTar BC G- Kit tests the following antimicrobial agents with the following bacterial species:

Amikacin: Citrobacter freundii, Enterobacter cloacae complex, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Serratia marcescens

Ampicillin: Escherichia coli, Proteus mirabilis

Ampicillin-sulbactam: Escherichia coli, Klebsiella oxytoca. Klebsiella pneumoniae. Proteus vulgaris

Aztreonam: Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, Serratia marcescens

Cefazolin: Klebsiella pneumoniae

Cefepime: Citrobacter freundii, Escherichia coli, Klebsiella oxytoca, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, Pseudomonas aeruginosa, Serratia marcescens

Ceftazidime: Enterobacter cloacae complex, Escherichia coli, Klebsiella oxytoca. Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, Serratia marcescens

Ceftazidime-avibactam: Citrobacter freundii, Citrobacter cloacae complex, Klebsiella oxytoca, Proteus mirabilis, Pseudomonas aeruginosa, Serratia marcescens

Cefuroxime: Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis

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Ciprofloxacin: Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, Pseudomonas aeruginosa, Serratia marcescens

Gentamicin: Citrobacter freundii, Citrobacter koseri, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, Pseudomonas aeruginosa, Serratia marcescens

Levofloxacin: Citrobacter freundii, Citrobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus vulgaris, Pseudomonas aerueinosa, Serratia marcescens

Meropenem: Acinetobacter baumanii, Citrobacter freundii, Citrobacter koseri, Escherichia coli, Proteus mirabilis, Proteus vulgaris, Pseudomonas aeruginosa, Serratia marcescens

Meropenem-vaborbactam: Citrobacter freundii, Citrobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Serratia marcescens

Piperacillin-tazobactam: Citrobacter koseri, Escherichia coli, Klebsiella pneumoniae, Proteus vulgaris, Serratia marcescens

Tigecycline: Citrobacter freundii, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Serratia marcescens

Tobramycin: Citrobacter freundii, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Serratia marcescens

Trimethoprim-sulfamethoxazole: Enterobacter cloacae complex, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus vulgaris

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# 8.0 510(k) Summary

Date of Submission: April 8th, 2024

- Sponsor: Q-linea Dag Hammarskjolds vag 52A Uppsala, Sweden 752 37
- Correspondent: MDC Associates, Inc. Peter Trabold, Ph.D., MBA 48 Dunham Ridge Road, Suite 4000 Beverly, MA 01915 Phone: [phone]

## 8.1 Device

| Name of Device: | ASTar® BC G- Kit and ASTar® Instrument |
|----------------------|------------------------------------------------------------------------------------|
| Common Name: | ASTar BC G- Kit and ASTar Instrument |
| Regulation Number: | 21 CRF 866.1650 |
| Classification Name: | A cellular analysis system for multiplexed antimicrobial susceptibility<br>testing |
| Regulatory Class: | Class II |
| Product Code: | SAN, LON |
| Predicate Device: | Accelerate PhenoTest BC Kit. DEN160032 |

## 8.2 Device Description

ASTar System is a fully automated system for antimicrobial susceptibility testing (AST). It consists of the ASTar Instrument which is used in combination with dedicated application kits. The ASTar

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BC G- Kit consists of the ASTar BC G- Consumable kit, ASTar BC G- Frozen insert, and ASTar BC G-Kit software which must be installed on the instrument to process the kit.

The system provides robust and consistent inoculum preparation for AST and utilizes high-speed, time-lapse microscopy imaging of pathogens in broth microdilution to determine minimum inhibitory concentration (MIC) and qualitative susceptibility results. Organism identification using an approved method is required to be entered into the ASTar Instrument for results to be reported.

The instrument is designed to carry out sample preparation of up to six samples in parallel, using a dedicated ASTar Cartridge consumable for each sample. In the subsequent AST culturing step, the instrument transfers the prepared sample into a second dedicated consumable, referred to as the ASTar Disc. Up to 12 Discs can be incubated simultaneously in the system. The processed samples can be in different stages of the processing protocol. New samples can be loaded in a random-access manner when there are available slots. Processing of loaded samples will, in most cases, start shortly after loading. If six samples are started at the same time limitations given by the sample scheduler will result in a queue. The operator interacts with the instrument via the touchscreen display by which the operator controls the instrument.

ASTar BC G- Kit is used for in vitro determination of antimicrobial susceptibility testing of commonly isolated bacteria derived from positive blood culture samples confirmed positive for Gram-negative bacteria by Gram stain. The antimicrobial and organism combinations are listed in Table 1. Reportable ranges for each antimicrobial are listed in Table 2.

To start an analysis approximately 1 mL of a positive blood culture, confirmed Gram-negative by Gram stain is pipetted into the ASTar Cartridge by the operator and loaded into the system, from which the system purifies and quantifies the bacterial concentration is adjusted to the appropriate inoculum concentration and produces an inoculum for analysis of non-fastidious organisms. The bacterial suspensions are transferred automatically to the ASTar Disc and antimicrobial susceptibility testing is performed based on a defined short-term protocol. Results are available within approximately six hours. Bacterial growth and response to relevant concentrations of different antimicrobial drugs are measured throughout the incubation period, using a high-performance optical detection system in combination with image analysis algorithms. The system generates an MIC and further qualitative susceptibility results (i.e., S, I, R) for the tested antimicrobials when applicable. The qualitative results are determined based on established breakpoints stipulated by applicable authorities, i.e., FDA, CLSI or EUCAST. FDA Susceptibility Testing Interpretive Criteria (STIC), aka "breakpoints" are found in Table 3.

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## Table 1: ASTar BC G- Kit Product Panel

| Antimicrobial class | Antimicrobial agent | A. baumannii | C. freundii | C. koseri | E. cloacae complex* | E. coli | K. aerogenes | K. oxytoca | K. pneumoniae | P. aeruginosa | P. mirabilis | P. vulgaris | S. marcescens |
|-----------------------------|-------------------------------|--------------|-------------|-----------|---------------------|---------|--------------|------------|---------------|---------------|--------------|-------------|---------------|
| Penicillins | Ampicillin | | | | | ● | | | | | | | |
| β-lactam combination agents | Ampicillin-sulbactam | | | | | ● | | ● | ● | | ● | ● | |
| β-lactam combination agents | Ceftazidime-avibactam | | ● | ● | ● | | | ● | | ● | ● | | ● |
| β-lactam combination agents | Meropenem-vaborbactam | | ● | ● | ● | ● | ● | ● | ● | | ● | | ● |
| β-lactam combination agents | Piperacillin-tazobactam | | | ● | | ● | | | ● | | ● | ● | ● |
| Cephalosporin | Cefazolin | | | | | | | | ● | | | | |
| Cephalosporin | Cefepime | | ● | | | ● | ● | ● | ● | ● | ● | ● | ● |
| Cephalosporin | Cefuroxime | | | | | ● | | ● | ● | | ● | | |
| Cephalosporin | Ceftazidime | | | | ● | ● | | ● | ● | | ● | ● | ● |
| Monobactam | Aztreonam | | | ● | ● | ● | ● | ● | ● | | | | |
| Carbapenem | Meropenem | ● | ● | ● | | ● | | | | ● | ● | ● | ● |
| Aminoglycoside | Gentamicin | | ● | ● | | | | ● | ● | ● | ● | ● | ● |
| Aminoglycoside | Tobramycin | | ● | ● | ● | ● | | | ● | | ● | | ● |
| Aminoglycoside | Amikacin | | ● | | ● | | ● | ● | ● | ● | ● | | ● |
| Tetracycline | Tigecycline | | ● | ● | ● | ● | ● | ● | ● | | | | |
| Fluoroquinolone | Ciprofloxacin | | | ● | ● | ● | ● | ● | ● | ● | ● | ● | |
| Fluoroquinolone | Levofloxacin | | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● |
| Miscellaneous | Trimethoprim-sulfamethoxazole | | | ● | ● | ● | ● | ● | | | ● | | |

* Enterobacter cloacae complex includes E. cloacae, E. asburiae and E. hormaechei.

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| | Table 2: Organisms Antimicrobial Reportable Ranges for AST and QC, Quality Control Strains and | | | | | |
|--|------------------------------------------------------------------------------------------------|--|--|--|--|--|
| | Acceptable Results. All concentrations are in µg/mL. | | | | | |

| Antimicrobial | ASTar BC G-<br>Reportable<br>Range<br>(AST)5 | ASTar BC G-<br>Reportable<br>Range<br>(QC) | <i>E. coli</i><br>ATCC<br>25922 | <i>P.</i><br><i>aeruginosa</i><br>ATCC 27853 | <i>K.</i><br><i>pneumoniae</i><br>ATCC<br>700603 | <i>K.</i><br><i>pneumoniae</i><br>ATCC BAA<br>2814 |
|-----------------------------------|----------------------------------------------|--------------------------------------------|---------------------------------|----------------------------------------------|--------------------------------------------------|----------------------------------------------------|
| Ampicillin | ≤1 to ≥128 | ≤0.5 to ≥128 | 2-8 | | >1284 | |
| Ampicillin-sulbactam | ≤1 to ≥1283 | ≤1 to ≥128 | 2-8 | | 8-32 | |
| Ceftazidime-avibactam | ≤0.125 to ≥64 | ≤0.06 to ≥64 | | 0.5-4 | 0.25-2 | |
| Meropenem-vaborbactam | ≤0.25 to ≥64 | ≤0.06 to ≥64 | | 0.125-1 | | 0.125-0.5 |
| Piperacillin-tazobactam | ≤0.25 to ≥512 | ≤0.125 to ≥5121<br>≤0.25 to ≥5122 | | 1-8 | 8-32 | |
| Cefazolin | ≤0.25 to ≥32 | ≤0.125 to ≥32 | 1-4 | | | |
| Cefepime | ≤0.25 to ≥128 | ≤0.125 to ≥128 | | 0.5-4 | | |
| Cefuroxime | <1 to ≥128 | ≤0.5 to ≥128 | 2-8 | | | |
| Ceftazidime | ≤0.25 to ≥128 | ≤0.125 to ≥1281<br>≤0.25 to ≥1282 | | 1-4 | 16-64 | |
| Aztreonam | ≤0.25 to ≥128 | ≤0.125 to ≥128 | | 2-8 | | |
| Meropenem | ≤0.06 to ≥128 | ≤0.03 to ≥128 | | 0.125-1 | | |
| Gentamicin | ≤0.25 to ≥64 | ≤0.25 to ≥64 | | 0.5-2 | | |
| Tobramycin | ≤0.06 to ≥64 | ≤0.06 to ≥64 | 0.25-1 | | | |
| Amikacin | ≤0.5 to ≥256 | ≤0.125 to ≥256 | 0.5-4 | | | |
| Tigecycline | ≤0.03 to ≥32 | ≤0.008 to ≥32 | 0.03-0.25 | | | |
| Ciprofloxacin | ≤0.125 to ≥16 | ≤0.06 to ≥16 | | 0.125-1 | | |
| Levofloxacin | ≤0.125 to ≥32 | ≤0.125 to ≥32 | | 0.5-4 | | |
| Trimethoprim-<br>sulfamethoxazole | ≤0.06 to ≥16 | ≤0.03 to ≥16 | ≤0.5 | | | |

1QC Reportable range for P. aeruginosa ATCC 27853

2QC Reportable range for K. pneumoniae ATCC 700603

3Truncate lower reportable range for Ampicillin-sulbactam/Proteus vulgaris combination to 2 μg/mL

4ASTar will report ≥128 µg/mL as an acceptable result.

5The reference range was truncated to match the AST BC G- reportable range for the following: Aztreonam/Klebsiella oxytoc: ≤0.015 ->256 µg/mL to ≤0.25 - ≥128 µg/mL; Ceftazidime/Escherichia coli: ≤0.03 - ≥256 µg/mL to ≤0.25 - ≥128 µg/mL; Ceftazidime/Klebsiella oxytoca: ≤0.03 - ≥256 µg/mL; Ceftazidime-avibactam/Citrobacter koseri: ≤0.015 -≥128 µg/mL to ≤0.125 - ≥64 µg/ml; Ceftazidime-avibactam/Klebsiella oxytoca: ≤0.015 - ≥128 µg/mL to ≤0.125 - ≥64 µg/mL; Meropenem/Citrobacter freundii: ≤0.004 - ≥1024 µg/mL; Meropenem/Escherichia coli: ≤0.004 - ≥1024 μg/mL to ≤0.06 - ≥128 μg/mL

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| Antimicrobial | Enterobacterales | | | P. aeruginosa | | | Acinetobacter spp. | | |
|-------------------------------|------------------|-----|-----|---------------|----|-----|--------------------|---|----|
| | S | I | R | S | I | R | S | I | R |
| Ampicillin | ≤8 | 16 | ≥32 | - | - | - | - | - | - |
| Ampicillin-sulbactam | ≤8 | 16 | ≥32 | - | - | - | - | - | - |
| Ceftazidime-avibactam | ≤8 | - | ≥16 | ≤8 | - | ≥16 | - | - | - |
| Meropenem-vaborbactam | ≤4 | 8 | ≥16 | - | - | - | - | - | - |
| Piperacillin-tazobactam | ≤8 | 16 | ≥32 | - | - | - | - | - | - |
| Cefazolin | ≤2 | 4 | ≥8 | - | - | - | - | - | - |
| Cefepime | ≤2 | 4-8 | ≥16 | ≤8 | - | ≥16 | - | - | - |
| Cefuroxime | ≤8 | - | ≥16 | - | - | - | - | - | - |
| Ceftazidime | ≤4 | 8 | ≥16 | - | - | - | - | - | - |
| Aztreonam | ≤4 | 8 | ≥16 | - | - | - | - | - | - |
| Meropenem | ≤1 | 2 | ≥4 | ≤2 | 4 | ≥8 | ≤2 | 4 | ≥8 |
| Gentamicin | ≤4 | 8 | ≥16 | ≤4 | 8 | ≥16 | - | - | - |
| Tobramycin | ≤4 | 8 | ≥16 | - | - | - | - | - | - |
| Amikacin | ≤16 | 32 | ≥64 | ≤16 | 32 | ≥64 | - | - | - |
| Tigecycline | ≤2 | 4 | ≥8 | - | - | - | - | - | - |
| Ciprofloxacin | ≤0.25 | 0.5 | ≥1 | ≤0.5 | 1 | ≥2 | - | - | - |
| Levofloxacin | ≤0.5 | 1 | ≥2 | ≤1 | 2 | ≥4 | - | - | - |
| Trimethoprim-sulfamethoxazole | ≤2 | - | ≥4 | - | - | - | - | - | - |

## Table 3: FDA Recognized Susceptibility Test Interpretive Criteria (STIC) / "Breakpoints" implemented in the kit software.

#### 8.3 Intended Use/Indications for Use

## Intended Use

The ASTar System is intended to be used for the automated quantitative susceptibility testing for most clinically significant microorganisms. The ASTar System does not provide organism identification.

## Indications for Use

The ASTar System, comprised of the ASTar Instrument with the ASTar BC G- Kit (ASTar BC G-Consumable kit, ASTar BC G- Frozen Insert, and ASTar BC G- Kit software), utilizes high-speed, time-lapse microscopy imaging of bacteria for the in vitro, quantitative determination of antimicrobial susceptibility of on-panel gram-negative bacteria. The test is performed directly on positive blood culture samples signaled as positive by a continuous monitoring blood culture

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system and confirmed to contain gram-negative bacilli by Gram stain. Organism identification is required for AST result interpretation and reporting.

Test results from the ASTar BC G- Kit should be interpreted in conjunction with other clinical and laboratory findings. Standard laboratory protocols for processing positive blood cultures should be followed to ensure availability of isolates for supplemental testing. Sub-culturing is necessary to support further testing for: bacteria and antimicrobials not on the ASTar BC G- panel, where inconclusive results are obtained, epidemiologic testing, recovery of organisms present in microbial samples, and susceptibility testing of bacteria in polymicrobial samples.

The ASTar BC G- Kit tests the following antimicrobial agents with the following bacterial species:

Amikacin: Citrobacter freundii, Enterobacter cloacae complex, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Serratia marcescens

Ampicillin: Escherichia coli, Proteus mirabilis

Ampicillin-sulbactam: Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris

Aztreonam: Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, Serratia marcescens

Cefazolin: Klebsiella pneumoniae

Cefepime: Citrobacter freundii, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, Pseudomonas aeruginosa, Serratia marcescens

Ceftazidime: Enterobacter cloacae complex, Escherichia oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, Serratia marcescens

Ceftazidime-avibactam: Citrobacter freundii, Citrobacter koseri, Enterobacter cloacae complex, Klebsiella oxytoca, Proteus mirabilis, Pseudomonas aeruginosa, Serratia marcescens

Cefuroxime: Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis

Ciprofloxacin: Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, Pseudomonas aeruginosa, Serratia marcescens

Gentamicin: Citrobacter freundii, Citrobacter koseri, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, Pseudomonas aeruginosa, Serratia marcescens

Levofloxacin: Citrobacter freundii, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, Pseudomonas aeruginosa, Serratia marcescens

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Page 8-7

Meropenem: Acinetobacter baumannii, Citrobacter freundii, Citrobacter koseri, Escherichia coli, Proteus mirabilis, Proteus vulgaris, Pseudomonas aeruginosa, Serratia marcescens

Meropenem-vaborbactam: Citrobacter freundii, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella pneumoniae, Proteus mirabilis, Serratia marcescens

Piperacillin-tazobactam: Citrobacter koseri, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Proteus vulgaris, Serratia marcescens

Tigecycline: Citrobacter freundii, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Serratia marcescens

Tobramycin: Citrobacter freundii, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Serratia marcescens

Trimethoprim-sulfamethoxazole: Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus vulgaris

## Special Conditions for Use Statements

- · Rx For Prescription Use Only

| 8.4 Comparison of Technological Characteristics with the Predicate |
|----------------------------------------------------------------------|
| Device |

| Description | Q-linea AB<br>ASTar BC G- Kit<br>K221688<br>(New Device) | Accelerate Diagnostics, Inc.<br>Accelerate PhenoTest BC Kit<br>DEN160032<br>(Predicate Device) |
|-----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code(s) | SAN, LON | PRH, NSU, PEO, PAM, PEN, LON |
| Primary Regulation | 21 CFR 866.1650 | 21 CFR 866.1650 |
| Device Class | II | II |
| Device Classification | Fully automated short-term<br>incubation cycle antimicrobial<br>susceptibility system | Positive Blood Culture Identification<br>and AST Kit |
| Intended Use/<br>Indication for Use | The ASTar System is intended to be<br>used for the automated<br>quantitative susceptibility testing<br>for most clinically significant<br>microorganisms. The ASTar System<br>does not provide organism<br>identification. | The Accelerate PhenoTest BC kit is a<br>multiplexed in vitro diagnostic test<br>utilizing both qualitative nucleic<br>acid fluorescence in situ<br>hybridization (FISH) identification<br>and quantitative, antimicrobial<br>susceptibility testing (AST) methods<br>and is intended for use with the<br>Accelerate Pheno system. The |
| Description | Q-linea AB<br>ASTar BC G- Kit<br>K221688<br>(New Device) | Accelerate Diagnostics, Inc.<br>Accelerate PhenoTest BC Kit<br>DEN160032<br>(Predicate Device) |
| | The ASTar System, comprised of the<br>ASTar Instrument with the ASTar BC<br>G- Kit (ASTar BC G- Consumable kit,<br>ASTar BC G- Frozen Insert, and<br>ASTar BC G- Kit software), utilizes<br>high-speed, time-lapse microscopy<br>imaging of bacteria for the <i>in vitro</i> ,<br>quantitative determination of<br>antimicrobial susceptibility of on-<br>panel gram-negative bacteria. The<br>test is performed directly on<br>positive blood culture samples<br>signaled as positive by a continuous<br>monitoring blood culture system<br>and confirmed to contain gram-<br>negative bacilli by Gram stain.<br>Organism identification is required<br>for AST result interpretation and<br>reporting.<br><br>Test results from the ASTar BC G-<br>Kit should be interpreted in<br>conjunction with other clinical and<br>laboratory findings. Standard<br>laboratory protocols for processing<br>positive blood cultures should be<br>followed to ensure availability of<br>isolates for supplemental testing.<br>Sub-culturing is necessary to<br>support further testing for: bacteria<br>and antimicrobials not on the ASTar<br>BC G- panel, where inconclusive<br>results are obtained, epidemiologic<br>testing, recovery of organisms<br>present in microbial samples, and<br>susceptibility testing of bacteria in<br>polymicrobial samples. | Accelerate PhenoTest BC kit is<br>capable of simultaneous detection<br>and identification of multiple<br>microbial targets followed by<br>susceptibility testing of the<br>appropriate detected bacterial<br>organisms. The Accelerate<br>PhenoTest BC kit is performed<br>directly on blood culture samples<br>identified as positive by a<br>continuous monitoring blood<br>culture system. Results are<br>intended to be interpreted in<br>conjunction with Gram stain results. |
| Instrument Required | ASTar Instrument | Accelerate Pheno System |
| Blood Culture Types<br>Tested | BD BACTEC: Standard/10<br>Aerobic, Anaerobic; Lytic/10 | BD BACTEC: Standard/10<br>Aerobic, Anaerobic; Lytic/10 |
| Description | Q-linea AB<br>ASTar BC G- Kit<br>K221688<br>(New Device) | Accelerate Diagnostics, Inc.<br>Accelerate PhenoTest BC Kit<br>DEN160032<br>(Predicate Device) |
| | Aerobic, Anaerobic | Aerobic, Anaerobic |
| | BioMeriuex BacT/ALERT:<br>Standard Aerobic, Anaerobic;<br>Plus Aerobic, Anaerobic; PF Plus | BioMeriuex BacT/ALERT:<br>Standard Aerobic, Anaerobic;<br>Plus Aerobic, Anaerobic; PF Plus |
| | | Versa TREK:<br>REDOX 1 and 2 |
| Antimicrobials<br>Tested | Amikacin<br>Ampicillin<br>Ampicillin-sulbactam<br>Aztreonam<br>Cefazolin<br>Cefepime<br>Ceftazidime<br>Ceftazidime-avibactam<br>Cefuroxime<br>Ciprofloxacin<br>Gentamicin<br>Meropenem<br>Meropenem-vaborbactam<br>Levofloxacin<br>Piperacillin-tazobactam<br>Tobramycin<br>Tigecycline<br>Trimethoprim-sulfamethoxazole | Amikacin<br>Ampicillin<br>Ampicillin-sulbactam<br>Aztreonam<br>Ceftazidime<br>Ceftaroline<br>Cefepime<br>Ceftriaxone<br>Ciprofloxacin<br>Daptomycin<br>Erythromycin<br>Ertapenem<br>Gentamicin<br>Linezolid<br>Meropenem<br>Piperacillin-tazobactam<br>Tobramycin<br>Vancomycin |
| Organisms Tested<br>for Antimicrobial<br>Susceptibility Testing | Gram-Negative Bacteria:<br>Acinetobacter baumannii<br>Citrobacter freundii<br>Citrobacter koseri<br>Enterobacter cloacae complex<br>Escherichia coli<br>Klebsiella aerogenes<br>Klebsiella oxytoca<br>Klebsiella pneumoniae<br>Pseudomonas aeruginosa<br>Proteus mirabilis | Gram-Negative Bacteria:<br>Acinetobacter baumannii<br>Citrobacter spp.<br>(i.e., Citrobacter freundii,<br>Citrobacter koseri, not<br>differentiated)<br>Enterobacter spp.<br>(i.e., Enterobacter cloacae,<br>Enterobacter aerogenes, not<br>differentiated)<br>Escherichia coli<br>Klebsiella spp.<br>(i.e., Klebsiella pneumoniae |
| Description | Q-linea AB<br>ASTar BC G- Kit<br>K221688<br>(New Device) | Accelerate Diagnostics, Inc.<br>Accelerate PhenoTest BC Kit<br>DEN160032<br>(Predicate Device) |
| | Serratia marcescens | Klebsiella oxytoca, not<br>differentiated) |
| | | Proteus spp.<br>(i.e., Proteus mirabilis, Proteus<br>vulgaris, not differentiated) |
| | | Pseudomonas aeruginosa |
| | | Serratia marcescens |
| | | Gram-Positive Bacteria:<br>Staphylococcus aureus |
| |…