← Product Code [LTT](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LTT) · K250084

# MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL) (K250084)

_Beckman Coulter, Inc. · LTT · Jul 18, 2025 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LTT/K250084

## Device Facts

- **Applicant:** Beckman Coulter, Inc.
- **Product Code:** [LTT](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LTT.md)
- **Decision Date:** Jul 18, 2025
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.1640
- **Device Class:** Class 2
- **Review Panel:** Microbiology
- **Attributes:** PCCP

## Intended Use

For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.

## Device Story

MicroScan Dried Gram-Negative MIC/Combo Panels are single-use, miniaturized broth dilution susceptibility tests. Panels contain dehydrated antimicrobial agents (Aztreonam 0.5-64 µg/mL) in broth. Laboratory professionals inoculate panels with standardized suspensions of isolated colonies from solid media. Panels are rehydrated with water and incubated for 16-20 hours at 35°C ± 1°C in a non-CO2 incubator. The minimum inhibitory concentration (MIC) is determined by identifying the lowest antimicrobial concentration inhibiting growth, either visually or via MicroScan instrumentation (WalkAway or autoSCAN-4). Results assist clinicians in selecting appropriate antimicrobial therapy for gram-negative bacterial infections.

## Clinical Evidence

Performance evaluated using 622 clinical and 148 challenge isolates. After excluding non-indicated species, 540 clinical and 108 challenge isolates were analyzed. Overall essential agreement (EA) and category agreement (CA) were generally >90%. Specific limitations were established for organism/method combinations showing unacceptable major or very major error rates (e.g., Citrobacter koseri, Proteus mirabilis, E. coli). No clinical data; performance based on bench-top comparative testing against reference broth microdilution.

## Technological Characteristics

Miniaturized broth microdilution panel; dehydrated antimicrobial agent (Aztreonam). Incubation: 35°C ± 1°C, aerobic, 16-20 hours. Reading: Visual or automated (WalkAway/autoSCAN-4). Single-use. Complies with Class II Special Controls Guidance for AST Systems.

## 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.

## Predicate Devices

- MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL) ([K202343](/device/K202343.md))

## 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.
>
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FDA U.S. FOOD & DRUG ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

ASSAY ONLY

## I Background Information:

A 510(k) Number

K250084

B Applicant

Beckman Coulter, Inc.

C Proprietary and Established Names

MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL)

D Regulatory Information

|  Product Code(s) | Classification | Regulation Section | Panel  |
| --- | --- | --- | --- |
|  LTT | Class II | 21 CFR 866.1640 - Antimicrobial Susceptibility Test Powder | MI - Microbiology  |
|  JWY | Class II | 21 CFR 866.1640 - Antimicrobial susceptibility test powder | MI - Microbiology  |
|  LRG | Class II | 21 CFR 866.1640 - Antimicrobial susceptibility test powder | MI - Microbiology  |
|  LTW | Class II | 21 CFR 866.1640 - Antimicrobial susceptibility test powder | MI - Microbiology  |

## II Submission/Device Overview:

### A Purpose for Submission:

To obtain a substantial equivalence determination for aztreonam at concentrations of 0.5-64 µg/mL with the MicroScan Dried Gram-Negative MIC/Combo Panels for susceptibility testing of non-fastidious Gram-negative organisms.

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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B Measurand:

Aztreonam in the dilution range of 0.5-64 µg/mL

C Type of Test:

Quantitative antimicrobial susceptibility test (AST)

III Intended Use/Indications for Use:

A Intended Use(s):

For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.

B Indication(s) for Use:

The MicroScan Dried Gram-Negative MIC/Combo Panel is used to determine quantitative and qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-negative bacilli. After inoculation, panels are incubated for 16-20 hours at 35°C ± 1°C in a non-CO2 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert.

This particular submission is for the addition of the antimicrobial aztreonam at concentrations of 0.5-64 µg/mL to the test panel. Testing is indicated for Enterobacterales and Pseudomonas aeruginosa, as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC) webpage.

The MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL) has demonstrated acceptable performance with the following organisms:

Enterobacterales (Citrobacter freundii complex, Citrobacter koseri, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Morganella morganii, Yersinia enterocolitica)

Pseudomonas aeruginosa

C Special Conditions for Use Statement(s):

Rx - For Prescription Use Only

Results obtained with the organism/antimicrobial agent combinations listed below have shown discrepant MIC's when compared with an overnight reference method. Test results for these organisms will not be reported, and an alternate method for testing should be used.

Aztreonam: Enterobacter cloacae complex, Serratia marcescens, Serratia liquefaciens complex, Proteus vulgaris, Providencia stuartii, and Providencia rettgeri.

Performance of aztreonam when testing Citrobacter koseri have shown discrepant MICs (unacceptable essential agreement and an elevated very major error rate) when compared with the reference method across all read methods with the Prompt inoculation system. An alternate testing method (e.g., autoSCAN-4/WalkAway/manual reads with turbidity inoculation) should be used for aztreonam with Citrobacter koseri.

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Performance of aztreonam when testing M. morganii and P. mirabilis using the Prompt inoculation method with all read methods was outside of essential agreement with unacceptable major error rates compared to the reference method. M. morganii and P. mirabilis should only be tested with the turbidity inoculation method.

Due to the occurrence of major errors with aztreonam, P. mirabilis isolates with an MIC ≥ 16 µg/mL run on the WalkAway/Turbidity method should be read manually prior to reporting.

Due to the occurrence of a very major error involving a single E. coli isolate tested with aztreonam, isolates with an MIC ≤ 4 µg/mL run on the autoSCAN-4/Turbidity method should be read manually prior to reporting.

Performance of aztreonam when testing Yersinia enterocolitica using the Prompt inoculation method with the WalkAway read method were within categorical agreement, but outside of essential agreement due to a single isolate when compared to the reference method. Yersinia enterocolitica results with the Prompt/WalkAway should be read manually prior to reporting.

The ability of the MicroScan Dried Gram Negative Panels to detect resistance to aztreonam is unknown with Y. enterocolitica because an insufficient number of resistant strains were available at the time of comparative testing. Isolates yielding MIC results suggestive of a resistant interpretive category should be submitted to a reference laboratory.

## D Special Instrument Requirements:

MicroScan panels can be read either manually or automatically on the WalkAway or autoScan-4 instrument systems.

## IV Device/System Characteristics:

### A Device Description:

The MicroScan Dried Gram-Negative MIC/Combo panel with aztreonam is used to determine the quantitative and/or qualitative antimicrobial agent susceptibility of aerobic and facultatively anaerobic Gram-negative bacilli colonies grown on solid media. After inoculation, panels are incubated for 16-20 hours at 35°C ± 1° in a non-CO2 incubator and read either visually or with MicroScan instrumentation according to the package insert.

Inoculation methods: Turbidity or Prompt Inoculation System

Read methods: Manual, MicroScan WalkAway System and MicroScan autoSCAN-4

### B Principle of Operation:

The antimicrobial susceptibility tests are dehydrated miniaturizations of the broth dilution susceptibility test. Various antimicrobial agents are diluted in Mueller Hinton broth supplemented with calcium and magnesium to concentrations spanning the range of clinical interest. Breakpoint Combo panels use concentrations equivalent to the categorical breakpoints

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determined or recognized by FDA. After inoculation and rehydration with a standardized suspension of organism and incubation at 35°C for a minimum of 16 hours, the minimum inhibitory concentration (MIC) for the test organism is determined by observing the lowest antimicrobial concentration showing inhibition of growth.

V Substantial Equivalence Information:

A Predicate Device Name(s):
MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL)

B Predicate 510(k) Number(s):
K202343

C Comparison with Predicate(s):

|  Device & Predicate Device(s): | Device: K250084 | Predicate: K202343  |
| --- | --- | --- |
|  Device Trade Name | MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (Azt) (0.5-64 µg/mL) | MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL)  |
|  General Device Characteristic Similarities  |   |   |
|  Intended Use/Indications For Use | Determination of susceptibility with Gram-negative bacilli | Same  |
|  Technology | Overnight microdilution MIC susceptibility test | Same  |
|  Specimen | Isolated colonies from culture | Same  |
|  Incubation Temperature | 35 °C ± 1°C | Same  |
|  Incubation Atmosphere | Aerobic | Same  |
|  Incubation Time | 16-20 hours | Same  |
|  Reading Method | Automated (WalkAway or autoSCAN-4) or Manual | Same  |
|  Result Reported | Report results as minimum inhibitory concentration (MIC) and categorical interpretation (SIR) | Same  |
|  General Device Characteristic Differences  |   |   |
|  Antimicrobial Agent | Dried Aztreonam 0.5-64 µg/mL | Dried Ceftazidime 0.5-64 µg/mL  |

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VI Standards/Guidance Documents Referenced:

CLSI M07, 11th ed., "Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard" (January 2018)

CLSI M100, 35th ed., "Performance Standards for Antimicrobial Susceptibility Testing" (January 2025)

Guidance for Industry and FDA - Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems, August 28, 2009

VII Performance Characteristics (if/when applicable):

A Analytical Performance:

1. Precision/Reproducibility:

A reproducibility study was conducted at three clinical sites using 10 isolates of Gram-negative organisms that were consistent with the device intended use. The range of aztreonam dilutions tested was 0.5-64 µg/mL. Isolates were tested in triplicate over three days at three clinical sites (27 data points per isolate). The isolates tested in the reproducibility study included 4 isolates of Pseudomonas aeruginosa, 3 isolates of Klebsiella aerogenes, 2 isolates of Klebsiella oxytoca, and 1 isolate of Enterobacter cloacae complex.

Inocula were prepared using both the turbidity and Prompt methods and results were read manually (visually) and with the WalkAway and autoSCAN-4 instrument systems. The mode (or median for results without a mode) of MIC values was determined for each isolate and the reproducibility was calculated based on the number of MIC values that fell within ± one doubling dilution of the mode/median MIC value. The majority of data points were within ± one doubling dilution of the mode/median MIC value. The data was analyzed as described in the Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems. For those read/inoculation combinations that included off-scale results, reproducibility was assessed as best-case and worst-case scenarios (Table 1).

Table 1. Reproducibility of Aztreonam with All Inoculation and Read Methods

|  Read Method | Reproducibility
No. within ± one dilution of the mode/median MIC value (%)  |   |   |   |
| --- | --- | --- | --- | --- |
|   |  Prompt Inoculation |   | Turbidity Inoculation  |   |
|   |  Best | Worst | Best | Worst  |
|  WalkAway | 266/270 (98.5) | 259/270 (95.5) | 270/270 (100) | 264/270 (97.8)  |
|  autoSCAN-4 | 265/270 (98.1) | 258/270 (95.6) | 266/270 (98.5) | 256/270 (95.0)  |
|  Manual | 267/270 (98.9) | 262/270 (97.0) | 266/270 (98.5) | 261/270 (96.7)  |

Reproducibility performance was considered acceptable for all inoculation and read methods.

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2. Linearity:

Not applicable.

3. Analytical Specificity/Interference:

Not applicable.

4. Assay Reportable Range:

Not applicable.

5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):

Inoculum Density Check. A spectrophotometric device, the MicroScan Turbidity Meter, was used to ensure the accuracy of the turbidity inoculation method. A zero check of the turbidity meter was performed daily. The inocula prepared using the turbidity method were standardized using a reading of 0.08 ± 0.02 (equivalent to a 0.5 McFarland barium sulfate turbidity standard). The digital reading was recorded for each isolate and was considered acceptable based on recommendations in the Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems. Inoculum density colony counts were evaluated from suspensions of the QC strain E. coli ATCC 25922 and were found to be within the acceptable concentration range as recommended in the CLSI document M07, Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically.

Inoculum density data was collected for the Prompt inoculum preparation of all reproducibility isolates and weekly testing of QC strains E. coli ATCC 25922 and P. aeruginosa ATCC 27853, as well as monthly QC testing with the turbidity inoculation method. The overall average colony count was within the acceptable range for all isolates.

Purity Check. Purity checks were performed on all isolates for each inoculum preparation; only results from pure cultures were included.

Growth Failure Rate. During the clinical study, no isolates failed to grow on the dried test panels and frozen reference panel which is acceptable (<10% growth failure).

Quality Control Testing. The CLSI-recommended QC organisms E. coli ATCC 25922 and P. aeruginosa ATCC 27853 were tested with all inoculation and read methods using eight dilutions of aztreonam (0.5 – 64 µg/mL). The reference panel was inoculated using the turbidity method only. In this submission, the QC ranges for P. aeruginosa ATCC 27853 reflect the current MIC ranges recommended in the CLSI document M100, Performance Standards for Antimicrobial Susceptibility Testing 35th ed. The results of QC testing are shown in Table 2. For P. aeruginosa ATCC 27853, quality control results were within the acceptable range for all inoculation and read methods for ≥95% of tests which is acceptable. The device does not include the full CLSI/FDA-recommended dilution range for E. coli ATCC25922. Results ≤ the lowest dilution on the panel (i.e., ≤0.5 µg/mL) were considered an acceptable result and ≥95% of tests were in that range for all inoculation and read methods.

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Table 2. Quality Control Results for all Inoculation and Read Methods for Aztreonam

|  Organism | Conc. (μg/mL) ^{1} | Reference ^{2} | Prompt Inoculation Method |   |   | Turbidity Inoculation Method  |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   |   |   |  autoSCAN-4 | Manual | WalkAway | autoSCAN-4 | Manual | WalkAway  |
|  E. coli ATCC 25922
Expected Range 0.06-0.5 μg/mL | ≤ 0.5 | 186 | 179 | 180 | 180 | 183 | 184 | 185  |
|   |  1 | 1 | 5 | 3 | 4 | 1 | 2 | 1  |
|   |  2 |  | 2 | 3 | 2 | 1 |  | 1  |
|   |  4 |  | 1 |  |  |  |  |   |
|   |  8 |  |  | 1 |  | 1 | 1 | 1  |
|   |  16 |  |  |  |  |  |  |   |
|   |  32 |  |  |  | 1 | 2 | 2 | 2  |
|   |  64 | 2 |  |  |  |  |  |   |
|   |  > 64 |  |  |  |  |  |  |   |
|  P. aeruginosa ATCC 27853
Expected Range 2-8 μg/mL | ≤ 0.5 |  |  |  |  |  |  |   |
|   |  1 |  |  |  |  |  |  |   |
|   |  2 | 2 | 117 | 113 | 89 | 123 | 114 | 87  |
|   |  4 | 162 | 60 | 67 | 75 | 48 | 59 | 80  |
|   |  8 | 24 | 11 | 8 | 18 | 11 | 13 | 16  |
|   |  16 |  |  |  | 7 | 2 |  | 2  |
|   |  32 |  |  |  |  | 1 |  | 1  |
|   |  64 | 1 |  |  |  |  |  |   |
|   |  > 64 |  |  |  |  |  |  |   |

1 Does not include the full CLSI/FDA-recommended dilution range for QC testing of E. coli ATCC 25922 with the reference panel or the MicroScan panel. For E. coli ATCC25922, an acceptable result will be ≤ the lowest dilution on the panel (i.e., ≤0.5 μg/mL)<br/>
2 Frozen reference panel inoculated using the turbidity method and interpreted manually.

6. Detection Limit:<br/>
Not applicable/

7. Assay Cut-Off:<br/>
Not applicable.

B Comparison Studies:

1. Method Comparison with Predicate Device:<br/>
The results obtained with the MicroScan Dried Gram-Negative MIC/Combo Panel with Aztreonam (Azt) (0.5-64 μg/mL) were compared to results obtained using a frozen broth microdilution reference panel (dilution range 0.5-64 μg/mL). Clinical isolates were evaluated at three testing sites in the U.S.; challenge isolates were evaluated at one internal and one external clinical site.<br/>
The reference panel was prepared as described in CLSI document M07-A11 except for the use of Pluronic-F (wetting agent) in the inoculum water for the reference panel. A summary of historical data from previously cleared antimicrobial tests was provided in the submission

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which demonstrated that inclusion of the wetting agent did not affect testing. In addition, QC testing conducted during the clinical study was acceptable.

For the reference method and MicroScan panels inoculated using the turbidity method, panels were inoculated using the same standardized suspension further diluted into 25 mL of inoculum water with Pluronic-D (for the MicroScan panels) or Pluronic-F (for the frozen reference panels). MicroScan panels were also inoculated using the Prompt inoculation method with isolates inoculated into the Prompt inoculation bottle. Reference panels were read manually (visually) after 16-20 hours. MicroScan panels inoculated with both inoculation methods were read using the WalkAway and autoSCAN-4 instruments and by manual read after 16-18 hours.

## Clinical Study

To determine the performance of MicroScan Dried Gram-Negative MIC/Combo Panel with Aztreonam, a total of 622 gram-negative clinical isolates were evaluated with the Prompt inoculation method and the Turbidity inoculation method and all read methods at three clinical sites. Isolates included *Pseudomonas aeruginosa* (94 isolates) and Enterobacterales (528 isolates including 3 isolates of *Citrobacter amalonaticus*, 15 isolates of *Citrobacter fruendii*, 3 isolates of *Citrobacter koseri*, 41 isolates of *Enterobacter cloacae*, 1 isolate of *Enterobacter gergoviae*, 214 isolates of *Escherichia coli*, 1 isolate of *Hafnia alvei*, 17 isolates of *Klebsiella aerogenes* (formerly *Enterobacter aerogenes*), 14 isolates of *Klebsiella oxytoca*, 71 isolates of *Klebsiella pneumoniae*, 1 isolate of *Klebsiella spp.*, 16 isolates of *Morganella morganii*, 1 isolate of *pantoea agglomerans*, 89 isolates of *Proteus mirabilis*, 1 isolate of *Proteus penneri*, 2 isolates of *Proteus vulgaris*, 1 isolate of *Providencia rettgeri*, 3 isolates of *Providencia stuartii*, and 34 isolates of *Serratia marcescens*).

Performance when testing *Enterobacter cloacae* complex, *Serratia marcescens*, *Serratia liquefaciens* complex, *Proteus vulgaris*, *Providencia stuartii*, and *Providencia rettgeri* was not acceptable. These species were excluded from the intended use of the MicroScan Dried Gram-Negative MIC/Combo Panel with Aztreonam leaving a total of 540 clinical isolates (446 Enterobacterales and 94 *P. aeruginosa*) in the performance evaluation. This is addressed with the following limitation in the device labeling:

Results obtained with the organism/antimicrobial agent combinations listed below have shown discrepant MIC's when compared with an overnight reference method. Test results for these organisms will not be reported, and an alternate method for testing should be used.

Aztreonam: Enterobacter cloacae complex, Serratia marcescens, Serratia liquefaciens complex, Proteus vulgaris, Providencia stuartii, and Providencia rettgeri

Of the 540 clinical isolates (446 Enterobacterales and 94 *P. aeruginosa*) with results included in the performance analysis, a total of 471 (87.2%) were fresh isolates, and 69 (12.7%) were stock isolates (isolated from clinical specimens and tested beyond six months of isolation).

## Challenge Study

A total of 148 gram-negative challenge isolates were evaluated at two sites including *Pseudomonas aeruginosa* (21 isolates) and Enterobacterales (127 isolates including 6 isolates

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of Citrobacter fruendii, 3 isolates of Citrobacter koseri, 5 isolates of Enterobacter cloacae, 21 isolates of Escherichia coli, 11 isolates of Klebsiella aerogenes (formerly Enterobacter aerogenes), 6 isolates of Klebsiella oxytoca, 11 isolates of Klebsiella pneumoniae, 14 isolates of Morganella morganii, 6 isolates of Proteus mirabilis, 6 isolates of Proteus vulgaris, 8 isolates of Providencia rettgeri, 8 isolates of Providencia stuartii, 4 isolates of Serratia liquefaciens, 9 isolates of Serratia marcescens, and 9 isolates of Yersenia enterocolitica). Results obtained with Enterobacter spp., Serratia spp., Proteus vulgaris, Providencia stuartii, and Providencia rettgeri were removed from the device indications for use and were not included in analysis, leaving a total of 108 challenge isolates (87 Enterobacterales and 21 P. aeruginosa isolates) in the performance evaluation. One isolate of P. aeruginosa was not assessed in the Prompt inoculation method due to colony mucoid morphology leaving only 20 isolates for this evaluation.

Results for essential agreement, category agreement, and categorical errors for Enterobacterales and Pseudomonas aeruginosa for all inoculation and read methods are shown in Table 3 and Table 4. Essential agreement of evaluable results was calculated considering MIC results that were clearly identical to reference method results or clearly one doubling dilution higher or lower than the reference method results. Performance was evaluated separately for each organism group (i.e., Enterobacterales and  $P$  aeruginosa) due to differences in susceptibility test interpretive criteria.

For Y. enterocolitica, no resistant isolates were available for evaluation during clinical or challenge testing. This is addressed with the following limitation in the device labeling:

The ability of the MicroScan Dried Gram Negative Panels to detect resistance to aztreonam is unknown with Y. enterocolitica because an insufficient number of resistant strains were available at the time of comparative testing. Isolates yielding MIC results suggestive of a resistant interpretive category should be submitted to a reference laboratory.

Table 3. Performance of MicroScan Dried Gram-Negative Panels with Aztreonam, Using Prompt Inoculation and all Read Methods

|   | Tot | No. EA | EA % | Eval EA Tot | No. Eval EA | Eval EA % | No. CA | CA % | No. R/NS | No. S/SDD | min | maj | vmj  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  autoSCAN-4 Read  |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Overall Enterobacterales*, ≤4 (S), 8 (I), ≥16 (R)  |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Clinical | 446 | 422 | 94.6 | 57 | 33 | 57.9 | 428 | 96.0 | 46 | 392 | 10 | 8 | 0  |
|  Challenge | 87 | 73 | 83.9 | 50 | 36 | 72 | 74 | 85.1 | 47 | 37 | 9 | 2 | 2  |
|  Combined | 533 | 495 | 92.9 | 107 | 69 | 64.5 | 502 | 94.2 | 93 | 429 | 19 | 10 | 2  |
|  Pseudomonas aeruginosa, ≤8 (S), 16 (I), ≥32 (R)  |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Clinical | 94 | 89 | 94.7 | 83 | 78 | 94.0 | 88 | 93.6 | 14 | 70 | 6 | 0 | 0  |
|  Challenge | 20 | 19 | 95.0 | 20 | 19 | 95 | 12 | 60.0 | 8 | 4 | 8 | 0 | 0  |
|  Combined | 114 | 108 | 94.7 | 103 | 97 | 94.2 | 100 | 87.7 | 22 | 74 | 14 | 0 | 0  |
|  Manual Read  |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Overall Enterobacterales*, ≤4 (S), 8 (I), ≥16 (R)  |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Clinical | 446 | 422 | 94.6 | 57 | 33 | 57.9 | 426 | 95.5 | 46 | 392 | 11 | 9 | 0  |
|  Challenge | 87 | 73 | 83.9 | 51 | 37 | 72.6 | 74 | 85.1 | 47 | 37 | 9 | 2 | 2  |
|  Combined | 533 | 495 | 92.9 | 108 | 70 | 64.8 | 500 | 93.8 | 93 | 429 | 20 | 11 | 2  |
|  Pseudomonas aeruginosa, ≤8 (S), 16 (I), ≥32 (R)  |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Clinical | 94 | 90 | 95.7 | 84 | 80 | 95.2 | 86 | 91.5 | 14 | 70 | 7 | 1 | 0  |

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|   | Tot | No. EA | EA % | Eval EA Tot | No. Eval EA | Eval EA % | No. CA | CA % | No. R/NS | No. S/SDD | min | maj | vmj  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  Challenge | 20 | 19 | 95.0 | 20 | 19 | 95 | 12 | 60.0 | 8 | 4 | 8 | 0 | 0  |
|  Combined | 114 | 109 | 95.6 | 104 | 99 | 95.2 | 98 | 86.0 | 22 | 74 | 15 | 1 | 0  |
|  WalkAway Read  |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Overall Enterobacteriales*, ≤4 (S), 8 (I), ≥16 (R)  |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Clinical | 446 | 416 | 93.3 | 63 | 33 | 52.4 | 424 | 95.1 | 46 | 392 | 10 | 12 | 0  |
|  Challenge | 87 | 69 | 79.3 | 52 | 34 | 65.4 | 72 | 82.8 | 47 | 37 | 9 | 4 | 2  |
|  Combined | 533 | 485 | 91.0 | 115 | 67 | 58.3 | 496 | 93.1 | 93 | 429 | 19 | 16 | 2  |
|  Pseudomonas aeruginosa, ≤8 (S), 16 (I), ≥32 (R)  |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Clinical | 94 | 87 | 92.6 | 83 | 76 | 91.6 | 83 | 88.3 | 14 | 70 | 9 | 2 | 0  |
|  Challenge | 20 | 17 | 85.0 | 20 | 17 | 85 | 15 | 75.0 | 8 | 4 | 5 | 0 | 0  |
|  Combined | 114 | 104 | 91.2 | 103 | 93 | 90.3 | 98 | 86.0 | 22 | 74 | 14 | 2 | 0  |

*Includes 6.4% (34/533) of non-indicated Enterobacteriales

EA - Essential agreement

CA - Category agreement

EVAL - Evaluable isolates

min - minor discrepancies

maj - major discrepancies

vmj - very major discrepancies

S - Susceptible

SDD - Susceptible-Dose Dependent

R - Resistant

Essential agreement (EA) occurs when the result of the reference method and that of the MicroScan Dried Gram-Negative MIC/Combo Panel are within plus or minus one serial two-fold dilution of the antibiotic. Category agreement (CA) occurs when the interpretation of the result of the reference method agrees exactly with the interpretation provided by the MicroScan Dried Gram-Negative MIC/Combo Panel.

Table 4. Performance of MicroScan Dried Gram-Negative Panels with Aztreonam, Using Turbidity Inoculation and all Read Methods

|   | Tot | No. EA | EA % | Eval EA Tot | No. Eval EA | Eval EA % | No. CA | CA % | No. R/NS | No. S/SDD | min | maj | vmj  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  autoSCAN-4 Read  |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Overall Enterobacteriales*, ≤4 (S), 8 (I), ≥16 (R)  |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Clinical | 446 | 436 | 97.8 | 47 | 37 | 78.7 | 432 | 96.9 | 46 | 392 | 9 | 4 | 1  |
|  Challenge | 87 | 80 | 92.0 | 49 | 42 | 85.7 | 77 | 88.5 | 47 | 37 | 9 | 0 | 1  |
|  Combined | 533 | 516 | 96.8 | 96 | 79 | 82.3 | 509 | 95.5 | 93 | 429 | 18 | 4 | 2  |
|  Pseudomonas aeruginosa, ≤8 (S), 16 (I), ≥32 (R)  |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Clinical | 94 | 92 | 97.9 | 83 | 81 | 97.6 | 87 | 92.6 | 14 | 70 | 7 | 0 | 0  |
|  Challenge | 21 | 21 | 100 | 20 | 20 | 100 | 12 | 57.1 | 9 | 4 | 9 | 0 | 0  |
|  Combined | 115 | 113 | 98.3 | 103 | 101 | 98.1 | 99 | 86.1 | 23 | 74 | 16 | 0 | 0  |
|  Manual Read  |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Overall Enterobacteriales*, ≤4 (S), 8 (I), ≥16 (R)  |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Clinical | 446 | 435 | 97.5 | 48 | 37 | 77.1 | 432 | 96.9 | 46 | 392 | 10 | 4 | 0  |
|  Challenge | 87 | 81 | 93.1 | 50 | 44 | 88.0 | 76 | 87.4 | 47 | 37 | 10 | 0 | 1  |
|  Combined | 533 | 516 | 96.8 | 98 | 81 | 82.7 | 508 | 95.3 | 93 | 429 | 20 | 4 | 1  |
|  Pseudomonas aeruginosa, ≤8 (S), 16 (I), ≥32 (R)  |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Clinical | 94 | 91 | 96.8 | 84 | 81 | 96.43 | 86 | 91.5 | 14 | 70 | 7 | 1 | 0  |
|  Challenge | 21 | 21 | 100 | 20 | 20 | 100 | 12 | 57.1 | 9 | 4 | 9 | 0 | 0  |
|  Combined | 115 | 112 | 97.4 | 104 | 101 | 97.12 | 98 | 85.2 | 23 | 74 | 16 | 1 | 0  |
|  WalkAway Read  |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Overall Enterobacteriales*, ≤4 (S), 8 (I), ≥16 (R)  |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Clinical | 446 | 436 | 97.8 | 48 | 38 | 79.2 | 431 | 96.7 | 46 | 392 | 10 | 5 | 0  |
|  Challenge | 87 | 80 | 92.0 | 52 | 45 | 86.5 | 77 | 88.5 | 47 | 37 | 9 | 0 | 1  |
|  Combined | 533 | 516 | 96.8 | 100 | 83 | 83.0 | 508 | 95.3 | 93 | 429 | 19 | 5 | 1  |
|  Pseudomonas aeruginosa, ≤8 (S), 16 (I), ≥32 (R)  |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Clinical | 94 | 90 | 95.7 | 84 | 80 | 95.24 | 86 | 91.5 | 14 | 70 | 6 | 2 | 0  |
|  Challenge | 21 | 21 | 100 | 20 | 20 | 100 | 15 | 71.4 | 9 | 4 | 6 | 0 | 0  |

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|   | Tot | No. EA | EA % | Eval EA Tot | No. Eval EA | Eval EA % | No. CA | CA % | No. R/NS | No. S/SDD | min | maj | vmj  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  Combined | 115 | 111 | 96.5 | 104 | 100 | 96.15 | 101 | 87.8 | 23 | 74 | 12 | 2 | 0  |

*Includes 6.4% (34/533) of non-indicated Enterobacteriales

EA - Essential agreement

CA - Category agreement

EVAL - Evaluable isolates

min - minor discrepancies

maj - major discrepancies

vmj - very major discrepancies

S - Susceptible

SDD - Susceptible-Dose Dependent

R - Resistant

Essential agreement (EA) occurs when the result of the reference method and that of the MicroScan Dried Gram-Negative MIC/Combo Panel are within plus or minus one serial two-fold dilution of the antibiotic. Category agreement (CA) occurs when the interpretation of the result of the reference method agrees exactly with the interpretation provided by the MicroScan Dried Gram-Negative MIC/Combo Panel.

The overall EA and CA performance for Enterobacteriales for the WalkAway, autoSCAN-4, and manual read methods were acceptable ( $&gt;90\%$ ) for each inoculation method. A range of MAJ rates were observed for the different read and inoculation methods:  $0.9\%$  (4/429) to  $3.7\%$  (16/429), which is not acceptable. A range of VMJ rates were observed for the different read and inoculation methods:  $1.1\%$  (1/93) to  $2.1\%$  (2/93), which is acceptable. The unacceptable MAJ error rate observed for Enterobacteriales is addressed by the limitations described below.

When the performance for Enterobacteriales was evaluated individually by species, the following performance issues were observed:

When evaluating performance of  $E$  coli, the overall EA and CA performance for  $E$  coli for the WalkAway, autoSCAN-4, and manual read methods were acceptable with the prompt and turbidity inoculation methods. One very major error was observed, resulting in a VMJ rate of  $3.2\%$  (1/31), which was unacceptable. This is addressed with the following limitation in the device labeling:

Due to the occurrence of a very major error involving a single  $E$  coli isolate tested with aztreonam, isolates with an  $MIC \leq 4 \mu \mathrm{g} / \mathrm{mL}$  run on the autoSCAN-4/Turbidity method should be read manually prior to reporting.

When evaluating performance of  $P.$  mirabilis, the overall EA and CA performance for the manual read method was acceptable for the prompt inoculation method. The overall EA and CA performance for  $P.$  mirabilis for the WalkAway, AutoSCAN-4, and manual read methods were acceptable with the turbidity inoculation method. However, four major errors were observed with the AutoSCAN-4 read method resulting in a MAJ rate of  $4.4\%$  (4/92), six major errors were observed with the manual read method resulting in a MAJ rate of  $6.5\%$  (6/92), and eight major errors were observed with the WalkAway read method resulting in a MAJ rate of  $8.7\%$  (8/92) all using the prompt inoculation method, which was unacceptable. In addition, three major errors were observed with the WalkAway and turbidity inoculation method resulting in a MAJ rate of  $3.3\%$  (3/92), which is not acceptable. This is addressed with the following limitations in the device labeling:

Performance of aztreonam when testing M. morganii and P. mirabilis using the Prompt inoculation method with all read methods was outside of essential agreement with

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unacceptable major error rates compared to the reference method. M. morganii and P. mirabilis should only be tested with the turbidity inoculation method.

Due to the occurrence of major errors with aztreonam, P. mirabilis isolates with an MIC ≥ 16 µg/mL run on the WalkAway/Turbidity method should be read manually prior to reporting.

When evaluating performance of M. morgannii, the overall EA and CA performance for the WalkAway, AutoSCAN-4, and manual read methods were acceptable with the turbidity inoculation method. One major error was observed with the AutoSCAN-4 read method and manual read method resulting in a MAJ rate of 5.9% (1/17), and two major errors were observed with the WalkAway read method all using the prompt inoculation method resulting in a MAJ rate of 11.8% (2/17) which is not acceptable. This is addressed with a limitation in the device labeling (described above) to only test M. morganii with the turbidity inoculation method.

When evaluating performance of Citrobacter koseri, one very major error was observed with all read methods for the prompt inoculation method which resulted in a VMJ rate of 11.1% (1/9), which is not acceptable. This is addressed with the following limitation in the device labeling:

Performance of aztreonam when testing Citrobacter koseri have shown discrepant MICs (unacceptable essential agreement and an elevated very major error rate) when compared with the reference method across all read methods with the Prompt inoculation system. An alternate testing method (e.g. autoSCAN-4/WalkAway/manual reads with turbidity inoculation) should be used for aztreonam with Citrobacter koseri.

When evaluating performance of Citrobacter freundii complex, one very major error was observed with all read and inoculation methods resulting in a VMJ rate of 11.1% (1/9), which is not acceptable. This is addressed with the following footnote to the Performance Characteristics table in the device labeling:

For aztreonam, one resistant strain of Citrobacter freundii complex had a single very major error compared to the reference method across all read methods with turbidity inoculation.

When evaluating performance of Y. enterocolitica, one isolate was outside of essential agreement for the WalkAway read and Prompt inoculation method resulting in a EA rate of 88.9% (8/9), which is not acceptable. This is addressed with the following limitation in the device labeling:

Performance of aztreonam when testing Yersinia enterocolitica using the Prompt inoculation method with the WalkAway read method were within categorical agreement, but outside of essential agreement due to a single isolate when compared to the reference method. Yersinia enterocolitica results with the Prompt/WalkAway should be read manually prior to reporting.

The overall EA for P. aeruginosa for the WalkAway, autoSCAN-4, and manual read methods were acceptable (&gt;90%) for both inoculation methods. In addition, a range of MAJ

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rates was observed with all read methods when using the Prompt inoculation method: 0% (0/74) to 2.7% (2/74), which is acceptable. A range of MAJ rates was observed with all read methods when using the turbidity inoculation method: 0% (0/74) to 2.7% (2/74), which is acceptable. However, the CA was not acceptable across all read and inoculation methods. After further analysis, this was considered acceptable due to the acceptable performance of the evaluable isolates and the majority of the errors being minor. This is addressed with the following footnote to the Performance Characteristics table in the device labeling:

Categorical agreement for P. aeruginosa and aztreonam ranged from 85.2% (98/115) -- 87.8% (101/115) across all read and inoculation methods. Pseudomonas aeruginosa performance is acceptable due to the essential agreement of evaluable isolates ranging from 90.3% (93/103) -- 95.2% (99/104) and the majority of the categorical discrepancies were minor errors.

## Testing/Reporting MIC for Non-indicated Species

For this review, the interpretative criteria are applied to the organisms/organism groups according to the FDA STIC website. As required under 511A(2)(2)(B) of the Federal Food, Drug and Cosmetic Act, the following statement is added to the Warnings and Precautions section of the device labeling:

The safety and efficacy of antimicrobial drugs, for which antimicrobial susceptibility is tested by this AST device, may or may not have been established in adequate and well-controlled clinical trials for treating clinical infections due to microorganisms outside of those found in the indications and usage in the drug label. The clinical significance of susceptibility information in those instances is unknown. The approved labeling for specific antimicrobial drugs provides the uses for which the antimicrobial drug is approved.

## Trending

An analysis of trending was conducted using the combined clinical and challenge data for each organism group (Enterobacterales and P. aeruginosa) and for each inoculation and read method (Table 5). This trending calculation takes into account MIC values that are determined to be one or more doubling dilutions lower or higher compared to the reference method irrespective of whether the device MIC values are on-scale or not. Results that are not clearly at least one dilution lower, at least one dilution higher or in exact agreement with the CLSI reference method are not considered in the trending analysis.

Species for which the difference between the percentage of isolates with higher vs. lower readings was &gt; 30% and for which the confidence interval was determined to be statistically significant were considered to show evidence of trending. Trending that shows higher or lower MIC values compared to the reference is addressed in the labeling.

No trending was observed for Enterobacterales or P. aeruginosa organism groups with all inoculation and read methods. At a species level, a trend toward higher MIC values was observed for P. mirabilis across both inoculation methods and all read methods. A trend toward lower MIC values was observed for K. oxytoca (turbidity inoculation/all read methods and Prompt inoculation/manual read method), M. morganii (turbidity inoculation/all read methods), and Y. enterocolitica (turbidity inoculation/autoSCAN-4 read method and turbidity inoculation/manual read method).

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To address the MIC trending, the sponsor included the following footnote to the Performance Characteristics table in the device labeling:

Aztreonam MIC values for Enterobacterales were most frequently in exact agreement with the reference method. When not in agreement results tended to be one or more doubling dilutions higher for P. mirabilis with all read/all inoculation methods. When not in agreement results tended to be one doubling dilution lower for K. oxytoca and M. morganii with all read methods/turbidity inoculation, Y. enterocolitica with the autoSCAN-4/manual read methods/turbidity inoculation and K. oxytoca with the manual read /Prompt inoculation.

Table 5. Trending Observed for Aztreonam

|  Inoculation/ Read Method | Organism Group | Total Evaluable for Trending | ≥1 Dilution Lower # (%) | Exact # (%) | ≥1 Dilution Higher # (%) | Percent Difference (95% CI) | Trending Noted  |
| --- | --- | --- | --- | --- | --- | --- | --- |
|  Prompt/ autoSCAN-4 | Overall Enterobacterales | 130 | 47, (36.2) | 27 (20.7) | 56, (43.1) | 7%, (-5 to 18) | No  |
|   |  Pseudomonas aeruginosa | 107 | 39, (36.4) | 60 (56.1) | 8, (7.5) | -29%, (-39 to -18) | No  |
|  Prompt/ Manual | Overall Enterobacterales | 126 | 45, (35.7) | 30 (23.8) | 51, (40.5) | 5%, (-7 to 16) | No  |
|   |  Pseudomonas aeruginosa | 106 | 30, (28.3) | 62 (58.7) | 14, (13.2) | -15%, (-26, -4) | No  |
|  Prompt/ WalkAway | Overall Enterobacterales | 135 | 43, (31.9) | 29 (21.4) | 63, (46.7) | 15%, (3 to 26) | No  |
|   |  Pseudomonas aeruginosa | 105 | 19, (18.1) | 65 (x) | 21, (20.0) | 2%, (-9 to 13) | No  |
|  Turbidity/ autoSCAN-4 | Overall Enterobacterales | 112 | 59, (52.7) | 26 (x) | 27, (24.1) | -29%, (-40 to -16) | No  |
|   |  Pseudomonas aeruginosa | 106 | 42, (39.6) | 53 (x) | 11, (10.4) | -29%, (-40 to 18) | No  |
|  Turbidity/ Manual | Overall Enterobacterales | 112 | 55, (49.1) | 28 (x) | 29, (25.9) | -23%, (-35 to -11) | No  |
|   |  Pseudomonas aeruginosa | 107 | 39, (36.5) | 55 (x) | 13, (12.2) | -24%, (-35 to -13) | No  |
|  Turbidity/ WalkAway | Overall Enterobacterales | 115 | 56, (48.7) | 30 (x) | 29, (25.2) | -23%, (-35 to -11) | No  |
|   |  Pseudomonas aeruginosa | 106 | 30, (28.3) | 60 (x) | 16, (15.1) | -13%, (-24 to -2) | No  |

## Resistance Mechanism Characterization

Challenge isolates of Enterobacterales and $P_{\cdot}$ aeruginosa harboring various molecular mechanisms of resistance were tested with aztreonam. Challenge isolates included strains from the CDC and FDA Antibiotic Resistance Isolate Bank for evaluation.

2. Matrix Comparison:

Not applicable

## C Clinical Studies:

1. Clinical Sensitivity:

Not applicable.

2. Clinical Specificity:

Not applicable.

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3. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):

Not applicable.

# D Clinical Cut-Off:

Not applicable.

# E Expected Values/Reference Range:

Table 6: FDA-Identified and Recognized Interpretive Criteria for Aztreonam (μg/mL)

|  Organisms | Interpretive Criteriaa  |   |   |   |
| --- | --- | --- | --- | --- |
|   |  S | SDD | I | R  |
|  Enterobacterales | ≤4 | - | 8 | ≥16  |
|  Pseudomonas aeruginosa | ≤8 | - | 16 | ≥32  |

S = Susceptible; SDD = Susceptible-dose dependent; I = Intermediate; R = Resistant
aFDA-Recognized Antimicrobial Susceptibility Test Interpretive Criteria Website https://www.fda.gov/drugs/development-resources/fda-recognized-antimicrobial-susceptibility-test-interpretive-criteria

# VIII Proposed Labeling:

The labeling supports the finding of substantial equivalence for this device.

# IX Conclusion:

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

To support the implementation of changes to FDA-recognized susceptibility test interpretive criteria (i.e., breakpoints), this submission included a breakpoint change protocol that was reviewed and accepted by FDA. This protocol addresses future revisions to device labeling in response to breakpoint changes that are recognized on the FDA STIC webpage (https://www.fda.gov/drugs/development-resources/fda-recognized-antimicrobial-susceptibility-test-interpretive-criteria). The protocol outlined the specific procedures and acceptance criteria that Beckman Coulter, Inc. intends to use to evaluate the MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT)  $(0.5 - 64\mu \mathrm{g} / \mathrm{mL})$  device when revised breakpoints for aztreonam are published on the FDA STIC webpage. The breakpoint change protocol included with the submission indicated that if specific criteria are met, Beckman Coulter, Inc. will update the MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT)  $(0.5 - 64\mu \mathrm{g} / \mathrm{mL})$  device label to include (1) the new breakpoints, (2) an updated performance section after re-evaluation of data in this premarket notification with the new breakpoints, and (3) any new limitations as determined by their evaluation.

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LTT/K250084](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LTT/K250084)

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