← Product Code [LTT](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LTT) · K250036

# MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL) (K250036)

_Beckman Coulter, Inc. · LTT · Aug 15, 2025 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LTT/K250036

## Device Facts

- **Applicant:** Beckman Coulter, Inc.
- **Product Code:** [LTT](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LTT.md)
- **Decision Date:** Aug 15, 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 Positive MIC/Combo, Dried Gram Positive Breakpoint Combo panels. MicroScan Gram Positive panels are designed for use in determining antimicrobial agent susceptibility of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and Listeria monocytogenes.

## Device Story

MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin are dehydrated broth microdilution panels for antimicrobial susceptibility testing (AST). The device uses Mueller Hinton broth supplemented with calcium and magnesium to determine the minimum inhibitory concentration (MIC) of daptomycin (0.06-32 µg/mL) for gram-positive cocci. Inoculation is performed via turbidity or Prompt methods; panels are incubated for 16-20 hours at 35°C. Results are obtained via manual visual inspection or automated reading using MicroScan WalkAway or autoSCAN-4 systems. The device provides MIC values and categorical interpretations (S, SDD, R) to assist clinicians in selecting appropriate antimicrobial therapy. Limitations exist for specific species/method combinations (e.g., E. faecium/Prompt/WalkAway) requiring manual confirmation of results ≥8 µg/mL.

## Clinical Evidence

Performance evaluated using 950 clinical and 121 challenge gram-positive isolates. Study compared MicroScan panels (Prompt and Turbidity inoculation; WalkAway, autoSCAN-4, and manual read) against frozen broth microdilution reference panels. Primary endpoints were Essential Agreement (EA) and Category Agreement (CA). Overall EA and CA were >90% for most groups. Specific limitations were established for E. faecium (Prompt/WalkAway), S. capitis/hominis (Turbidity/autoSCAN-4), and S. simulans/warneri (Prompt) due to unacceptable error rates. Trending analysis identified bias for higher MIC values in specific combinations, addressed via labeling footnotes.

## Technological Characteristics

Miniaturized broth microdilution panel; dehydrated antimicrobial agent (Daptomycin 0.06-32 µg/mL). Incubation: 35°C ± 1°C, aerobic, 16-20 hours. Reading: Visual or automated (WalkAway/autoSCAN-4). Single-use. Inoculation via standardized suspension.

## 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-Positive MIC/Combo Panels with Vancomycin ([K150039](/device/K150039.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

K250036

B Applicant

Beckman Coulter, Inc.

C Proprietary and Established Names

MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 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 daptomycin at concentrations of 0.06-32 µg/mL with the MicroScan Dried Gram-Positive MIC/Combo Panels for susceptibility testing of non-fastidious gram-positive organisms.

### B Measurand:

Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov

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Daptomycin in the dilution range of 0.06-32 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 Positive MIC/Combo, Dried Gram Positive Breakpoint Combo panels. MicroScan Positive panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and Listeria monocytogenes.

### B Indication(s) for Use:

The MicroScan Dried Gram-Positive 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 gram-positive cocci, some fastidious aerobic gram-positive cocci and Listeria monocytogenes. 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 daptomycin at concentrations of 0.06-32 µg/mL to the test panel. Testing is indicated for Enterococcus faecium, Enterococcus spp. other than E. faecium, and Staphylococcus spp., as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC) webpage.

The MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (Dap) (0.06-32 µg/mL) has demonstrated acceptable performance with the following organisms:

**Enterococcus faecium**

Enterococcus spp. other than E. faecium (Enterococcus faecalis, Enterococcus avium, Enterococcus raffinosus, Enterococcus casseliflavus and Enterococcus durans)

Staphylococcus spp. (Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus capitis, Staphylococcus haemolyticus, Staphylococcus lugdunensis, Staphylococcus hominis, Staphylococcus warneri, Staphylococcus simulans, Staphylococcus saprophyticus, Staphylococcus intermedius, and Staphylococcus sciuri)

### C Special Conditions for Use Statement(s):

Rx - For Prescription Use Only

Performance of daptomycin when testing Enterococcus faecium using the Prompt inoculation method and WalkAway read method showed unacceptable adjusted potential major error rates compared to the reference method (6.3%, 4/63). Due to the occurrence of potential major errors

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with *E. faecium* and daptomycin with the WalkAway read with prompt inoculation, MIC results of $\geq 8\ \mu\mathrm{g/mL}$ should be confirmed by manual read prior to reporting.

Performance of daptomycin when testing *Staphylococcus capitis* and *Staphylococcus hominis* using the turbidity inoculation method with autoSCAN-4 read method was outside of essential agreement compared to the reference method. *S. capitis* and *S. hominis* species when using the turbidity inoculation method should only be read with the WalkAway and manual read methods.

Performance of daptomycin when testing *Staphylococcus simulans* and *Staphylococcus warneri* using the Prompt inoculation method with all read methods was outside of essential agreement compared to the reference method. *S. simulans* and *S. warneri* species should only be tested with the turbidity inoculation method.

## 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-Positive MIC/Combo Panel with daptomycin is used to determine the quantitative and/or qualitative antimicrobial agent susceptibility of rapidly growing aerobic and facultative gram-positive cocci colonies grown on solid media. After inoculation, panels are incubated for 16-20 hours at $35^{\circ}\mathrm{C} \pm 1^{\circ}\mathrm{C}$ 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 determined or recognized by FDA. After inoculation and rehydration with a standardized suspension of organism and incubation at $35^{\circ}\mathrm{C}$ 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 Positive MIC/Combo Panels with Vancomycin $(0.25-64\ \mu\mathrm{g/mL})$

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

K150039

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C Comparison with Predicate(s):

|  Device & Predicate Device(s): | Device: K250036 | Predicate: K150039  |
| --- | --- | --- |
|  Device Trade Name | MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (Dap) (0.06-32 μg/mL) | MicroScan Dried Gram-Positive MIC/Combo Panels with Vancomycin (0.25-64 μg/mL)  |
|  General Device Characteristic Similarities  |   |   |
|  Intended Use/Indications For Use | Determination of susceptibility with Gram-positive bacteria | 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 with appropriate categorical interpretation | Same  |
|  General Device Characteristic Differences |  |   |
|  Antimicrobial Agent | Dried Daptomycin 0.06-32 μg/mL | Dried Vancomycin 0.25-64 μg/mL  |
|  Tested species | Enterococcus faecium
Enterococcus spp. other than E. faecium (Enterococcus faecalis, Enterococcus avium, Enterococcus raffinosus, Enterococcus casseliflavus and Enterococcus durans)
Staphylococcus spp. (Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus capitis, Staphylococcus haemolyticus, Staphylococcus lugdunensis, Staphylococcus hominis, Staphylococcus warneri, Staphylococcus simulans, Staphylococcus saprophyticus, | Enterococci (e.g., Enterococcus faecalis)
Staphylococci, including Staphylococcus aureus and Staphylococcus epidermidis (including heterogenous methicillin-resistant strains)  |

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|  Device & Predicate Device(s): | Device: K250036 | Predicate: K150039  |
| --- | --- | --- |
|   | Staphylococcus intermedius, and Staphylococcus sciuri) |   |

# VI Standards/Guidance Documents Referenced:

- CLSI M07,  $11^{\text{th}}$  ed., "Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard" (January 2018)
- CLSI M100,  $35^{\text{th}}$  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 four clinical sites using 12 isolates of gram-positive isolates that were consistent with the device intended use. The range of daptomycin dilutions tested was  $0.06 - 32\mu \mathrm{g / mL}$ . Isolates were tested in triplicate over three days at four clinical sites (36 data points per isolate) for a total of 431 data points (due to one replicate failure). The isolates tested in the reproducibility study included four (4) isolates of Staphylococcus aureus and eight (8) isolates of Enterococcus faecalis.

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  $\pm$  one doubling dilution of the mode/median MIC value. The majority of data points were within  $\pm$  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 Daptomycin 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 | 428/431 (99.3) | 428/431 (99.3) | 430/431 (99.8) | 430/431 (99.8)  |
|  autoSCAN-4 | 422/431 (97.9) | 422/431 (97.9) | 421/431 (97.7) | 421/431 (97.7)  |
|  Manual | 429/431 (99.5) | 429/431 (99.5) | 430/431 (99.8) | 430/431 (99.8)  |

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

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 $0.08 \pm 0.02$ (equivalent to a $0.5\mathrm{McFarland}$ 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 S. aureus ATCC 29213 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 S. aureus ATCC 29213 and E. faecalis ATCC 29212, 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 S. aureus ATCC 29213 and E. faecalis ATCC 29212 were tested with all inoculation and read methods using ten (10) dilutions of daptomycin $(0.06 - 32\mu \mathrm{g / mL})$. The reference panel was inoculated using the turbidity method only. In this submission, the QC ranges for both S. aureus ATCC 29213 and E. faecalis ATCC 29212 reflect the current MIC ranges recommended in the CLSI document M100, Performance Standards for Antimicrobial Susceptibility Testing $35^{\mathrm{th}}$ ed.. The results of QC testing are shown in Table 2. For both QC strains, quality control results were within the acceptable range for all inoculation and read methods for $\geq 95\%$ of tests which is acceptable.

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

|  Organism | Conc. (μg/mL) | Reference^{1} | Prompt Inoculation Method |   |   | Turbidity Inoculation Method  |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   |   |   |  autoSCAN-4 | Manual | WalkAway | autoSCAN-4 | Manual | WalkAway  |
|  S. aureus ATCC 29213
Expected Range 0.12-1 μg/mL | ≤ 0.06 |  |  |  |  |  |  |   |
|   |  0.12 | 14 | 1 | 1 | 1 | 4 | 3 | 4  |
|   |  0.25 | 210 | 70 | 65 | 67 | 217 | 216 | 219  |
|   |  0.5 | 5 | 146 | 150 | 152 | 4 | 6 | 3  |
|   |  1 |  | 9 | 13 | 9 | 4 | 4 | 4  |
|   |  2 |  |  |  |  |  |  |   |
|   |  4 |  | 1 | 1 | 1 |  |  |   |
|   |  8 |  |  |  |  |  |  |   |
|   |  16 |  |  |  |  |  |  |   |
|   |  32 |  |  |  |  |  |  |   |
|   |  > 32 |  |  |  |  |  |  |   |
|  E. faecalis ATCC 29212
Expected Range 1-4 μg/mL | ≤ 0.06 |  |  |  |  | 1 |  |   |
|   |  0.12 |  |  |  |  |  |  |   |
|   |  0.25 |  |  |  |  |  |  |   |
|   |  0.5 |  |  |  |  |  |  |   |
|   |  1 | 46 | 14 | 11 | 1 | 11 | 6 | 1  |
|   |  2 | 181 | 124 | 112 | 107 | 178 | 170 | 177  |
|   |  4 | 1 | 92 | 106 | 121 | 39 | 52 | 50  |
|   |  8 |  |  |  | 1 |  |  | 1  |
|   |  16 |  |  |  |  |  |  |   |
|   |  32 |  |  |  |  |  |  |   |
|   |  > 32 |  |  |  |  |  |  |   |

1 Frozen reference panel inoculated using the turbidity method and interpreted manually.

6. Detection Limit:
Not applicable

7. Assay Cut-Off:
Not applicable

B Comparison Studies:

1. Method Comparison with Predicate Device:

The results obtained with the MicroScan Dried Gram-Positive MIC/Combo Panel with Daptomycin (0.06-32 μg/mL) were compared to results obtained using a frozen broth microdilution reference panel (dilution range 0.06-32 μg/mL). Clinical isolates were evaluated at four testing sites in the U.S.; challenge isolates were evaluated at one internal and one external site.

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

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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 16-20 hours.

## Clinical Study

To determine the performance of MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin, a total of 950 gram-positive clinical isolates were evaluated with the Prompt inoculation method and the Turbidity inoculation method and all read methods at four clinical sites. Isolates included Enterococcus faecium (51 isolates), Enterococcus spp. other than E. faecium [118 isolates including E. avium (3), E. casseliflavus (2), E. durans (2), E. faecalis (92), E. gallinarum (3), E. raffinosus (3), and Enterococcus spp. (13)] , and Staphylococcus spp. [781 isolates including S. aureus (414), S. auricularis (2) S. capitis (13), S. epidermidis (205), S. equorum (1), S. haemolyticus (39), S. hominis (20), S. intermedius (2), S. lugdunensis (28), S. saprophyticus (9), S. sciuri (1), S. simulans (10), S. warneri (14), and Staphylococcus spp. (23)].

Of the 950 clinical isolates with results included in the performance analysis, 690 (72.6%) were recent/contemporary isolates (isolated from clinical specimens and tested within six months of isolation with minimal sub-culturing), and 260 (27.4%) were stock isolates.

## Challenge Study

A total of 121 gram-positive challenge isolates from species with STIC-recognized breakpoints were evaluated at two sites including Enterococcus faecium (36 isolates), Enterococcus faecalis (35 isolates), and Staphylococcus aureus (50 isolates).

Results for essential agreement, category agreement, and categorical errors for E. faecium, Enterococcus spp. other than E. faecium, and Staphylococcus spp. for all inoculation and read methods are shown in Table 3 and Table 4 below. 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., E. faecium, Enterococcus spp. other than E. faecium, and Staphylococcus spp.) in accordance with the appropriate susceptibility test interpretive criteria for each group. Data for all species within a group were analyzed for performance separately and combined in accordance with the STIC-recognized breakpoints for the group then presented combined as shown in Table 3 and Table 4. Footnotes and limitations were applied in labeling as appropriate.

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Table 3. Performance of MicroScan Dried Gram-Postive Panels with Daptomycin, 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  |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Staphylococcus spp., ≤1 (S)  |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Clinical | 781 | 726 | 93.0 | 757 | 702 | 92.7 | 779 | 99.7 | 2 | 779 | 0 | 0 | 1  |
|  Challenge | 50 | 50 | 100 | 50 | 50 | 100 | 48 | 96.0 | 19 | 31 | 0 | 0 | 0  |
|  Combined | 831 | 776 | 93.4 | 807 | 752 | 93.2 | 827 | 99.5 | 21 | 810 | 0 | 0 | 1  |
|  Enterococcus faecium, ≤4 (SDD), ≥8 (R)  |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Clinical | 51 | 47 | 92.2 | 49 | 45 | 91.8 | 46 | 90.2 | 2 | 49 | 0 | 2 | 0  |
|  Challenge | 36 | 36 | 100 | 36 | 36 | 100 | 36 | 100 | 22 | 14 | 0 | 0 | 0  |
|  Combined | 87 | 83 | 95.4 | 85 | 81 | 95.3 | 82 | 94.3 | 24 | 63 | 0 | 2 | 0  |
|  Enterococcus spp. other than E. faecium, ≤2 (S), 4 (I), ≥8 (R)  |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Clinical | 118 | 115 | 97.5 | 117 | 114 | 97.4 | 114 | 96.6 | 0 | 116 | 4 | 0 | 0  |
|  Challenge | 35 | 34 | 97.1 | 34 | 33 | 97.1 | 31 | 88.6 | 8 | 23 | 3 | 0 | 1  |
|  Combined | 153 | 149 | 97.4 | 151 | 147 | 97.4 | 145 | 94.8 | 8 | 139 | 7 | 0 | 1  |
|  Manual Read  |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Staphylococcus spp., ≤1 (S)  |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Clinical | 781 | 725 | 92.8 | 765 | 709 | 92.7 | 780 | 99.9 | 2 | 779 | 0 | 0 | 0  |
|  Challenge | 50 | 49 | 98.0 | 50 | 49 | 98.0 | 48 | 96.0 | 19 | 31 | 0 | 0 | 0  |
|  Combined | 831 | 774 | 93.1 | 815 | 758 | 93.0 | 828 | 99.6 | 21 | 810 | 0 | 0 | 0  |
|  Enterococcus faecium, ≤4 (SDD), ≥8 (R)  |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Clinical | 51 | 48 | 94.1 | 49 | 46 | 93.9 | 47 | 92.2 | 2 | 49 | 0 | 2 | 0  |
|  Challenge | 36 | 36 | 100 | 36 | 36 | 100 | 36 | 100 | 22 | 14 | 0 | 0 | 0  |
|  Combined | 87 | 84 | 96.6 | 85 | 82 | 96.5 | 83 | 95.4 | 24 | 63 | 0 | 2 | 0  |
|  Enterococcus spp. other than E. faecium, ≤2 (S), 4 (I), ≥8 (R)  |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Clinical | 118 | 117 | 99.2 | 117 | 116 | 99.2 | 113 | 95.8 | 0 | 116 | 5 | 0 | 0  |
|  Challenge | 35 | 35 | 100 | 34 | 34 | 100 | 31 | 88.6 | 8 | 23 | 4 | 0 | 0  |
|  Combined | 153 | 152 | 99.4 | 151 | 150 | 99.3 | 144 | 94.1 | 8 | 139 | 9 | 0 | 0  |
|  WalkAway Read  |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Staphylococcus spp., ≤1 (S)  |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Clinical | 781 | 734 | 94.0 | 763 | 716 | 93.8 | 779 | 99.7 | 2 | 779 | 0 | 0 | 0  |
|  Challenge | 50 | 50 | 100 | 50 | 50 | 100 | 48 | 96.0 | 19 | 31 | 0 | 0 | 0  |
|  Combined | 831 | 784 | 94.3 | 813 | 766 | 94.2 | 827 | 99.5 | 21 | 810 | 0 | 0 | 0  |
|  Enterococcus faecium, ≤4 (SDD), ≥8 (R)  |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Clinical | 51 | 43 | 84.3 | 49 | 41 | 83.7 | 44 | 86.3 | 2 | 49 | 0 | 4 | 0  |
|  Challenge | 36 | 36 | 100 | 36 | 36 | 100 | 36 | 100 | 22 | 14 | 0 | 0 | 0  |
|  Combined | 87 | 79 | 90.8 | 85 | 77 | 90.6 | 80 | 92.0 | 24 | 63 | 0 | 4 | 0  |
|  Enterococcus spp. other than E. faecium, ≤2 (S), 4 (I), ≥8 (R)  |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Clinical | 118 | 118 | 100 | 117 | 117 | 100 | 113 | 95.8 | 0 | 116 | 5 | 0 | 0  |
|  Challenge | 35 | 35 | 100 | 34 | 34 | 100 | 31 | 88.6 | 8 | 23 | 4 | 0 | 0  |
|  Combined | 153 | 153 | 100 | 151 | 151 | 100 | 144 | 94.1 | 8 | 139 | 9 | 0 | 0  |

EA - Essential agreement
min - Minor discrepancies
S - Susceptible
CA - Category agreement
maj - Major discrepancies
SDD - Susceptible-dose dependent
EVAL - Evaluable isolates
vmj - Very major discrepancies
R - Resistant

Essential agreement (EA) occurs when the result of the reference method and that of the MicroScan Dried Gram-Positive 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-Positive MIC/Combo Panel.

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Table 4. Performance of MicroScan Dried Gram-Positive Panels with Daptomycin, 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  |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Staphylococcus spp., ≤1 (S)  |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Clinical | 781 | 760 | 97.3 | 734 | 713 | 97.1 | 778 | 99.6 | 2 | 779 | 0 | 1 | 2  |
|  Challenge | 50 | 50 | 100 | 50 | 50 | 100 | 49 | 98.0 | 19 | 31 | 0 | 0 | 0  |
|  Combined | 831 | 810 | 97.5 | 784 | 763 | 97.3 | 827 | 99.5 | 21 | 810 | 0 | 1 | 2  |
|  Enterococcus faecium, ≤4 (SDD), ≥8 (R)  |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Clinical | 51 | 48 | 94.1 | 49 | 46 | 93.9 | 50 | 98.0 | 2 | 49 | 0 | 0 | 0  |
|  Challenge | 36 | 36 | 100 | 36 | 36 | 100 | 35 | 97.2 | 22 | 14 | 0 | 0 | 0  |
|  Combined | 87 | 84 | 96.6 | 85 | 82 | 96.5 | 85 | 97.7 | 24 | 63 | 0 | 0 | 0  |
|  Enterococcus spp. other than E. faecium, ≤2 (S), 4 (I), ≥8 (R)  |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Clinical | 118 | 113 | 95.8 | 117 | 112 | 95.7 | 115 | 97.5 | 0 | 116 | 3 | 0 | 0  |
|  Challenge | 35 | 35 | 100 | 34 | 34 | 100 | 35 | 100 | 8 | 23 | 0 | 0 | 0  |
|  Combined | 153 | 148 | 96.7 | 151 | 146 | 96.7 | 150 | 98.0 | 8 | 139 | 3 | 0 | 0  |
|  Manual Read  |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Staphylococcus spp., ≤1 (S)  |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Clinical | 781 | 775 | 99.2 | 748 | 742 | 99.2 | 780 | 99.9 | 2 | 779 | 0 | 0 | 0  |
|  Challenge | 50 | 50 | 100 | 50 | 50 | 100 | 49 | 98.0 | 19 | 31 | 0 | 0 | 0  |
|  Combined | 831 | 825 | 99.3 | 798 | 792 | 99.3 | 829 | 99.8 | 21 | 810 | 0 | 0 | 0  |
|  Enterococcus faecium, ≤4 (SDD), ≥8 (R)  |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Clinical | 51 | 51 | 100 | 49 | 49 | 100 | 50 | 98.0 | 2 | 49 | 0 | 0 | 0  |
|  Challenge | 36 | 36 | 100 | 36 | 36 | 100 | 35 | 97.2 | 22 | 14 | 0 | 0 | 0  |
|  Combined | 87 | 87 | 100 | 85 | 85 | 100 | 85 | 97.7 | 24 | 63 | 0 | 0 | 0  |
|  Enterococcus spp. other than E. faecium, ≤2 (S), 4 (I), ≥8 (R)  |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Clinical | 118 | 117 | 99.2 | 117 | 116 | 99.2 | 115 | 97.5 | 0 | 116 | 3 | 0 | 0  |
|  Challenge | 35 | 35 | 100 | 34 | 34 | 100 | 33 | 94.3 | 8 | 23 | 2 | 0 | 0  |
|  Combined | 153 | 152 | 99.4 | 151 | 150 | 99.3 | 148 | 96.7 | 8 | 139 | 5 | 0 | 0  |
|  WalkAway Read  |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Staphylococcus spp., ≤1 (S)  |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Clinical | 781 | 772 | 98.9 | 743 | 734 | 98.8 | 779 | 99.7 | 2 | 779 | 0 | 0 | 1  |
|  Challenge | 50 | 50 | 100 | 50 | 50 | 100 | 49 | 98.0 | 19 | 31 | 0 | 0 | 0  |
|  Combined | 831 | 822 | 98.9 | 793 | 784 | 98.9 | 828 | 99.6 | 21 | 810 | 0 | 0 | 1  |
|  Enterococcus faecium, ≤4 (SDD), ≥8 (R)  |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Clinical | 51 | 48 | 94.1 | 49 | 46 | 93.9 | 49 | 96.1 | 2 | 49 | 0 | 1 | 0  |
|  Challenge | 36 | 36 | 100 | 36 | 36 | 100 | 34 | 94.4 | 22 | 14 | 0 | 0 | 0  |
|  Combined | 87 | 84 | 96.6 | 85 | 82 | 96.5 | 83 | 95.4 | 24 | 63 | 0 | 1 | 0  |
|  Enterococcus spp. other than E. faecium, ≤2 (S), 4 (I), ≥8 (R)  |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  Clinical | 118 | 117 | 99.2 | 117 | 116 | 99.2 | 116 | 98.3 | 0 | 116 | 2 | 0 | 0  |
|  Challenge | 35 | 35 | 100 | 34 | 34 | 100 | 32 | 91.4 | 8 | 23 | 3 | 0 | 0  |
|  Combined | 153 | 152 | 99.4 | 151 | 150 | 99.3 | 148 | 96.7 | 8 | 139 | 5 | 0 | 0  |

EA - Essential agreement
min - Minor discrepancies
S - Susceptible
CA - Category agreement
maj - Major discrepancies
SDD - Susceptible-dose dependent
EVAL - Evaluable isolates
vmj - Very major discrepancies
R - Resistant

Essential agreement (EA) occurs when the result of the reference method and that of the MicroScan Dried Gram-Positive 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-Positive MIC/Combo Panel.

K250036 - Page 10 of 15

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# Enterococcus faecium

The overall EA and CA performance for *Enterococcus faecium* for the WalkAway, autoSCAN-4, and manual read methods were acceptable (>90%) for each inoculation method. A range of MAJ rates were observed for the different read methods with the Prompt inoculation method: 4.8% (3/63) to 9.5% (6/63), which is not acceptable. In addition, a range of VMJ rates were observed for the different read and inoculation methods: 4.2% (1/24) to 12.5% (3/24), which is not acceptable. Since there is no defined susceptible interpretive category (S) for daptomycin with *Enterococcus faecium*, the susceptible-dose dependent (SDD) category is treated as an S for performance analysis. Due to the lack of intermediate interpretive criteria, further analysis of the errors was performed and adjustments were made by considering the MIC values of the errors compared to the reference MIC value. All very major errors had an MIC value that was in essential agreement with the reference MIC value. Therefore, the adjusted VMJ rate is 0.0% (0/24), which is acceptable.

Some major errors had an MIC value that was in essential agreement with the reference method. After adjustment, there remained two (2) major errors for the autoSCAN-4 and Manual read methods when using the prompt inoculation method resulting in an adjusted MAJ rate of 3.2% (2/63), which is acceptable. However, four (4) major errors remained with the WalkAWay read method when using the prompt inoculation method, resulting in an adjusted MAJ rate of 6.3% (4/63), which is not acceptable. This is addressed with the following limitation in the device labeling:

Performance of daptomycin when testing *Enterococcus faecium* using the Prompt inoculation method and WalkAway read method showed unacceptable adjusted potential major error rates compared to the reference method (6.3%, 4/63). Due to the occurrence of potential major errors with *E. faecium* and daptomycin with the WalkAway read with Prompt inoculation, MIC results of ≥8 μg/mL should be confirmed by manual read prior to reporting.

The following footnotes were also added to the performance characteristics table:

The overall potential major error rate for daptomycin and *E. faecium* with the autoSCAN-4 and Prompt inoculation was 6.3% (4/63) and 4.8% (3/63) for manual reads with Prompt inoculation. Some potential major errors were one dilution apart from the reference method are within essential agreement. Based on the essential agreement and lack of an intermediate breakpoint for daptomycin, the adjusted potential major error rate for *E. faecium* is 3.2% (2/63) for the autoSCAN-4 and manual reads with Prompt inoculation. The adjusted potential major error rate is considered acceptable for the autoSCAN-4 and manual reads with Prompt inoculation.

The overall potential very major error rate for daptomycin and *E. faecium* with Prompt and turbidity inoculation across all read methods (WalkAway, autoSCAN-4, and manual) ranged from 4.2% (1/24) to 12.5% (3/24). All potential very major errors were one dilution apart from the reference method and are within essential agreement. Based on the essential agreement and the lack of an intermediate breakpoint for daptomycin, the adjusted potential very major error rate for *E. faecium* is 0% (0/24).

K250036 - Page 11 of 15

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# Enterococcus spp. other than E. faecium

The overall EA and CA performance for Enterococcus spp. other than E. faecium for the WalkAway, autoSCAN-4, and manual read methods were acceptable (>90%) for each inoculation method. No major errors were observed. One very major error was observed for an E. faecalis isolate with autoSCAN-4 read method using the Prompt inoculation method, resulting in a VMJ rate of 12.5% (1/8), which is not acceptable. Due to the limited number of resistant isolates tested, the error was considered random. This is addressed with the following footnote to the performance characteristics table in the device labeling:

One very major error (VMJ) was observed with daptomycin when testing Enterococcus faecalis with the Prompt inoculation and autoSCAN-4 read method that resulted in an unacceptable VMJ rate (12.5%, 1/8). This was considered random due to the limited number of resistant E. faecalis isolates tested.

# Staphylococcus spp.

The overall EA and CA performance for Staphylococcus spp. for the WalkAway, autoSCAN-4, and manual read methods were acceptable (>90%) for each inoculation method. A range of potential MAJ rates were observed for the different read and inoculation methods: 0.1% (1/808) to 0.2% (2/808), which is acceptable. One (1) potential very major error was observed for the Prompt and turbidity inoculation methods with all read methods, resulting in a potential VMJ rate of 5% (1/20), which is not acceptable. These are considered potential errors because no interpretive category other than "susceptible only" is defined for Staphylococcus spp. with daptomycin. Due to the lack of an intermediate interpretive criteria, further analysis of the errors is performed and adjustments are made by considering the MIC values where the errors occurred. All potential major errors had an MIC value that was in essential agreement with the reference MIC value, except for one MIC value obtained with the autoScan-4 read method using the turbidity inoculation method. This resulted in an adjusted potential MAJ rate of 0.1% (1/808), which is acceptable. In addition, all potential very major errors had an MIC value that was in essential agreement with the reference MIC value, except for one MIC value obtained with the autoSCAN-4 read method using the Prompt and turbidity inoculation methods. This resulted in an adjusted potential VMJ rate of 5.0% (1/20) which is not acceptable. When evaluating by individual species, the one (1) adjusted potential very major error was due to S. capitis. Due to the limited number of resistant isolates tested with this species (one resistant isolate), the error was considered random. This is addressed in the following footnote to the performance characteristics table in the device labeling:

Two adjusted potential very major errors (VMJ) were observed with daptomycin when testing S. capitis and S. auricularis with the turbidity and Prompt inoculation with the autoSCAN-4 read method that resulted in an unacceptable adjusted potential VMJ rate (100%, 1/1 per species). These were considered random due to the limited number of resistant S. capitis and S. auricularis isolates tested.

Device performance was also evaluated by individual species with STIC-recognized breakpoints within the Staphylococcus spp. reporting group. All species that demonstrated acceptable performance, with acceptable mitigations as described below, were included in the indications for use.

K250036 - Page 12 of 15

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When evaluating performance of S. capitis, the autoSCAN-4 read and turbidity inoculation method demonstrated an EA of 84.6%, which is not acceptable, and a CA of 92.3%. When evaluating performance of S. hominis, the autoSCAN-4 read and Turbidity inoculation method demonstrated an EA rate of 85.0%, which is not acceptable, and a CA of 100%. This is addressed with the following limitation in the device labeling:

Performance of daptomycin when testing Staphylococcus capitis and Staphylococcus hominis using the turbidity inoculation method with autoSCAN-4 read method was outside of essential agreement compared to the reference method. S. capitis and S. hominis species when using the turbidity inoculation method should only be read with the WalkAway and manual read methods.

When evaluating performance of S. simulans, the Prompt inoculation method demonstrated unacceptable EA with all read methods (autoSCAN-4 EA 70%, WalkAway EA 80%, manual EA 80%) with acceptable CA (100% for all read methods). When evaluating performance of S. warneri the Prompt inoculation method demonstrated unacceptable EA with all read methods (autoSCAN-4 EA 78.6%, WalkAway EA 78.6%, manual EA 85.7%) with acceptable CA (100% for all read methods). This is addressed with the following limitation in the device labeling:

Performance of daptomycin when testing Staphylococcus simulans and Staphylococcus warneri using the Prompt inoculation method with all read methods was outside of essential agreement compared to the reference method. S. simulans and S. warneri species should only be tested the turbidity inoculation method.

## 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

A trending analysis was conducted using the combined data (clinical and challenge) obtained with each organism group for each inoculation and read method (Table 5). This trending calculation analyzes device MIC values that are one or more doubling dilutions lower or higher than the reference method MIC values. MIC values that are off-scale for both the reference and device are not considered in the trending analysis. Organism groups or species for which the difference between the percentage of isolates with higher or lower MIC values was ≥30% with a statistically significant confidence interval were considered to have evidence of trending and is addressed in device labeling.

{13}

Table 5. Trending Observed for Daptomycin

|  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 | Staphylococcus spp. | 823 | 102, (12.4) | 364 (44.2) | 357, (43.4) | 31%, (27 to 35) | Yes  |
|   |  Enterococcus faecium | 85 | 9, (10.6) | 48 (56.5) | 28, (32.9) | 22%, (10 to 34) | No  |
|   |  Other Enterococcus spp. | 152 | 18, (11.8) | 88 (57.9) | 46, (30.3) | 18%, (9 to 27) | No  |
|  Prompt/ Manual | Staphylococcus spp. | 827 | 63, (7.6) | 372 (45.0) | 392, (47.4) | 40%, (36 to 44) | Yes  |
|   |  Enterococcus faecium | 85 | 3, (3.5) | 57 (67.1) | 25, (29.4) | 26%, (15 to 37) | No  |
|   |  Other Enterococcus spp. | 153 | 14, (9.2) | 93 (60.7) | 46, (30.1) | 21%, (12 to 29) | No  |
|  Prompt/ WalkAway | Staphylococcus spp. | 823 | 88, (10.7) | 372 (45.2) | 363, (44.1) | 33%, (29 to 37) | Yes  |
|   |  Enterococcus faecium | 85 | 5, (5.9) | 46 (54.1) | 34, (40.0) | 34%, (22 to 45) | Yes  |
|   |  Other Enterococcus spp. | 152 | 25, (16.5) | 105 (69.0) | 22, (14.5) | -2%, (-10 to 6) | No  |
|  Turbidity/ autoSCAN-4 | Staphylococcus spp. | 815 | 280, (34.4) | 498 (61.1) | 37, (4.5) | -29%, (-33 to -26) | No  |
|   |  Enterococcus faecium | 85 | 13, (15.3) | 52 (61.2) | 20, (23.5) | 8%, (-4 to 20) | No  |
|   |  Other Enterococcus spp. | 152 | 25, (16.5) | 105 (69.0) | 22, (14.5) | -2%, (-10 to 6) | No  |
|  Turbidity/ Manual | Staphylococcus spp. | 815 | 234, (28.7) | 534 (65.5) | 47, (5.8) | -23%, (-26 to -19) | No  |
|   |  Enterococcus faecium | 85 | 9, (10.6) | 66 (77.6) | 10, (11.8) | 1%, (-9 to 11) | No  |
|   |  Other Enterococcus spp. | 152 | 19, (12.5) | 111 (73.0) | 22, (14.5) | 2%, (-6 to 10) | No  |
|  Turbidity/ WalkAway | Staphylococcus spp. | 815 | 266, (32.6) | 511 (62.7) | 38, (4.7) | -28%, (-31 to -24) | No  |
|   |  Enterococcus faecium | 85 | 9, (10.6) | 54 (63.5) | 22, (25.9) | 15%, (4 to 27) | No  |
|   |  Other Enterococcus spp. | 152 | 17, (11.2) | 110 (72.3) | 25, (16.5) | 5%, (-3 to 13) | No  |

A bias for higher MIC values was observed for Enterococcus faecium with WalkAway and the Prompt inoculation method, and for Staphylococcus aureus with all read methods and the Prompt inoculation method. These are addressed in the following footnotes to the performance table in the device labeling:

Daptomycin MIC values for Staphylococcus spp. and E. faecium were most frequently in exact agreement with the reference method with prompt inoculation. When not in agreement results tended to be one or more doubling dilution higher for Staphylococcus spp. across all read methods and for E. faecium with the WalkAway.

2. Matrix Comparison:

Not applicable

C Clinical Studies:

1. Clinical Sensitivity:

Not applicable

2. Clinical Specificity:

Not applicable

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

Not applicable

K250036 - Page 14 of 15

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# D Clinical Cut-Off:

Not applicable

# E Expected Values/Reference Range:

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

|  Organisms | Interpretive Criteriaa  |   |   |   |
| --- | --- | --- | --- | --- |
|   |  S | SDD | I | R  |
|  Staphylococcus spp. | ≤1 | - | - | -  |
|  E. faecium | - | ≤4 | - | ≥8  |
|  Enterococcus spp. other than E. faecium | ≤2 | - | 4 | ≥8  |

S = Susceptible; SDD = Susceptible-dose dependent; I = Intermediate; R = Resistant
a FDA-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-Positive MIC/Combo Panels with Daptomycin (DAP)  $(0.6 - 32\mu \mathrm{g / mL})$  device when revised breakpoints for daptomycin 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-Positive MIC/Combo Panels with Daptomycin (DAP)  $(0.6 - 32\mu \mathrm{g / mL})$  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.

K250036 - Page 15 of 15

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LTT/K250036](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LTT/K250036)

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