← Product Code [LON](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON) · K140468

# BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAROLINE (0.625-4 UG/ML) (K140468)

_Becton, Dickinson and Company · LON · Jun 2, 2014 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON/K140468

## Device Facts

- **Applicant:** Becton, Dickinson and Company
- **Product Code:** [LON](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON.md)
- **Decision Date:** Jun 2, 2014
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.1645
- **Device Class:** Class 2
- **Review Panel:** Microbiology

## Indications for Use

The BD Phoenix™ Automated Microbiology System is intended for in vitro quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC) of most Gram-negative aerobic and facultative anaerobic bacteria isolates from pure culture for Enterobacteriaceae and Non-Enterobacteriaceae and most Gram-positive bacteria isolates from pure culture belonging to the genera Staphylococcus, Enterococcus and Streptococcus.

## Device Story

System performs automated antimicrobial susceptibility testing (AST) on bacterial isolates. Input: pure culture bacterial colonies suspended in broth (standardized to 0.5 McFarland via nephelometer). Process: broth microdilution in molded polystyrene trays containing dried reagents and redox indicator; incubation at 35°C; continuous monitoring of indicator color change (blue to pink to colorless) and turbidity via instrument sensors. Output: MIC values and interpretive categories (S, I, R). Used in clinical microbiology labs; operated by laboratory technicians. Software-driven 'EXPERT' system applies CLSI/FDA-derived rules to interpret growth data. Results assist clinicians in selecting appropriate antibiotic therapy for bacterial infections.

## Clinical Evidence

Performance evaluated using clinical and challenge isolates across multiple U.S. sites. Comparison against CLSI reference broth microdilution method. For Ceftaroline (0.0625-4 µg/mL) with Gram-positive organisms (n=866), Essential Agreement was 94.7% and Category Agreement was 98.2%. Reproducibility study showed >95% agreement (+/- 1 dilution) across three sites.

## Technological Characteristics

Broth-based microdilution system. Materials: molded polystyrene trays. Sensing: colorimetric oxidation-reduction (redox) indicator and turbidity measurement. Energy: electrical (automated incubation/monitoring). Connectivity: networked instrument. Software: rule-based 'EXPERT' system. Sterilization: not specified. Dimensions: 136 micro-well trays.

## Regulatory Identification

A fully automated short-term incubation cycle antimicrobial susceptibility system is a device that incorporates concentrations of antimicrobial agents into a system for the purpose of determining in vitro susceptibility of bacterial pathogens isolated from clinical specimens. Test results obtained from short-term (less than 16 hours) incubation are used to determine the antimicrobial agent of choice to treat bacterial diseases.

## Special Controls

*Classification.* Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA.”

## Predicate Devices

- Vitek® Antimicrobial Susceptibility Test System (N50510)

## 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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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

A. 510(k) Number:
K140468

B. Purpose for Submission:
Addition of Ceftaroline to the BD Phoenix Gram-positive ID/AST and AST only panels.

C. Measurand:
Ceftaroline 0.0625-4 µg/mL

D. Type of Test:
Antimicrobial Susceptibility Test (Quantitative) colorimetric, oxidation-reduction, growth based

E. Applicant:
Becton, Dickinson and Company

F. Proprietary and Established Names:
BD Phoenix™ Automated Microbiology System -Ceftaroline (CPT)- Gram-Positive ID/AST or AST only Phoenix Panels.

G. Regulatory Information:

1. Regulation section:
21 CFR 866.1645 – Fully Automated Short-Term Antimicrobial Susceptibility Test System

2. Classification:
Class II

3. Product code:
LON – System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

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4. Panel:

83 Microbiology

H. Intended Use:

1. Intended use(s):

The BD Phoenix™ Automated Microbiology System is intended for in vitro quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC) of most Gram-negative aerobic and facultative anaerobic bacteria isolates from pure culture for Enterobacteriaceae and Non-Enterobacteriaceae and most Gram-positive bacteria isolates from pure culture belonging to the genera Staphylococcus, Enterococcus and Streptococcus.

2. Indication(s) for use:

The BD Phoenix™ Automated Microbiology System is intended for in vitro quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC) of most Gram-negative aerobic and facultative anaerobic bacteria isolates from pure culture for Enterobacteriaceae and Non-Enterobacteriaceae and most Gram-positive bacteria isolates from pure culture belonging to the genera Staphylococcus, Enterococcus and Streptococcus.

This premarket notification is for the addition of the antimicrobial agent ceftaroline at concentrations of 0.0625-4 µg/mL to Gram-positive ID/AST or AST only Phoenix panels. Ceftaroline has been shown to be active in vitro against most strains of microorganisms listed below, as described in the FDA-approved package inserts for this antimicrobial agent.

Active in Vitro and in Clinical Infections Against:

Staphylococcus aureus (including methicillin-susceptible and -resistant isolates)

3. Special conditions for use statement(s):

For prescription use only

4. Special instrument requirements:

For use with the BD Phoenix™ Automated Microbiology System

I. Device Description:

This submission is for the AST Panel only. The ID system was not reviewed.

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The BD Phoenix™ Automated Microbiology System includes instrumentation and software, sealed and self-inoculating molded polystyrene trays with 136 micro-wells containing dried reagents, and specific inoculum broth formulations for identification (ID) and antimicrobial susceptibility testing (AST). The organism to be tested must be in pure culture and preliminarily identified as Gram-positive or Gram-negative. Colonies are then suspended in the ID broth, and, using one of the recommended BD nephelometer devices, brought to a concentration of 0.5 McFarland. A further dilution is made into the AST broth. Prior to inoculation of the panel, an AST broth indicator is added which changes the AST broth to a blue color. The AST broth is a cation-adjusted formulation of Mueller-Hinton broth containing 0.01% Tween 80, and has a final isolate concentration of approximately 5 x 10⁵ CFU/mL. After inoculation and incubation, the AST broth indicator in the AST broth changes from blue to pink to colorless as organism growth and reduction in the panel well occurs. Inoculated panels are barcode scanned and loaded into the BD Phoenix™ Automated Microbiology System instrument where the panels are incubated at 35°C and continuously measured for changes to the indicator and bacterial turbidity to determine bacterial growth in the presence of an antimicrobial agent. Organisms killed or inhibited by a given antimicrobial do not cause reduction of the indicator and therefore do not produce a color change. Additional interpretation is done using the software driven "EXPERT" System triggered rules derived from the CLSI standards and/or FDA drug labeling.

Readings are taken every 20 minutes and a final AST result is available in 4 to 16 hours. The AST result is determined via automated readings; no manual readings are possible with this system.

## J. Substantial Equivalence Information:

1. Predicate device name(s):

Vitek® Antimicrobial Susceptibility Test System

2. Predicate 510(k) number(s):

N50510

3. Comparison with predicate:

Table 1 Similarities and Differences of the BD Phoenix Ceftaroline and the Predicate

|  Similarities  |   |   |
| --- | --- | --- |
|  Item | Device | Predicate  |
|   | BD Phoenix Automated Microbiology System (Ceftaroline) | VITEK (N50510)  |
|  Intended Use | The BD Phoenix™ Automated Microbiology System is intended for the rapid identification and in vitro antimicrobial | The VITEK System is intended for the determination of in vitro susceptibility to antimicrobial agents for rapidly growing, aerobic  |

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|  Similarities  |   |   |
| --- | --- | --- |
|  Item | Device | Predicate  |
|   | BD Phoenix Automated Microbiology System (Ceftaroline) | VITEK (N50510)  |
|   | susceptibility testing of isolates from pure culture of most aerobic and facultative anaerobic Gram-negative and Gram-positive bacteria of human origin. | and/or facultative anaerobic Gram-negative and Gram-positive bacteria.  |
|  Sample | Bacterial colonies isolated from culture | Same  |
|  Incubation Time | Short-term (<16 hours) | Same  |
|  Test Card | Contains dried antimicrobials and substrates | Same  |
|  Results | MIC and Interpretive Criteria (i.e., Susceptible, Intermediate, and Resistant) | Same  |
|  Technology | Automated | Same  |
|  Differences  |   |   |
| --- | --- | --- |
|  Item | Device | Predicate  |
|  Methodology | MIC determination based on serial two-fold dilution format | MIC determination based on computer assisted extrapolation of doubling dilutions  |
|  Technology | Automated growth based, enhanced by use of a redox indicator (colorimetric oxidation-reduction) to detect organism growth | Automated growth based detection using attenuation of light measured by an optical scanner  |

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

- CLSI M7-A8 "Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically"
- CLSI M100-S22* "Performance Standards for Antimicrobial Susceptibility Testing"
- Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test Systems; Guidance for Industry and FDA

* For Ceftaroline QC parameters

# L. Test Principle:

The BD Phoenix™ Automated Microbiology System is a broth based microdilution method

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that utilizes a redox indicator (colorimetric oxidation-reduction) to enhance detection of organism growth. The MIC is determined by comparing growth in wells containing serial two-fold dilutions of an antibiotic to the growth in "growth control wells" that contain no antimicrobial agent.

## M. Performance Characteristics (if/when applicable):

### 1. Analytical performance:

#### a. Precision/Reproducibility:

Reproducibility testing using inocula prepared manually and using the BD Phoenix™ AP system using the PhoenixSpec nephelometer was conducted at three sites (one internal and two external). Ten isolates with on-scale MIC values as predetermined by reference methods were provided to the testing sites by BD. Isolate identification and expected MIC result was blinded to those conducting the testing. Testing was performed in triplicate on three separate days.

Reproducibility testing using inocula prepared by the Phoenix AP instrument was conducted at two external sites and one internal site. Testing was conducted using 10 isolates with on-scale MIC values. Isolate identification and expected MIC result was blinded to those conducting the testing. Testing was performed in triplicate on three separate days.

Results of the inter-site and intra-site reproducibility studies were acceptable and demonstrated best case and worst case results of greater than 95%. A summary of the reproducibility study performance is illustrated in Table 2 below.

Table 2 Summary of Reproducibility Studies – BD Phoenix Ceftaroline

|  BD Phoenix Instrument Platform | Inoculation Method | Best Case^{a} | Worst Case^{b}  |
| --- | --- | --- | --- |
|  BD Phoenix | AP Instrument | 100% | 100%  |
|   |  Manual | 100% | 100%  |

a Best case calculation for reproducibility assumes off-scale results are within one well of the mode MIC value
b Worst case calculation for reproducibility assumes off-scale results are greater than one well from the mode MIC value

In both manual and automated inoculation methods, all results were on-scale and within one well of the mode. There were a total of 270 (10 strains x 3 sites x 3 replicates x 3 days) MIC results evaluated in the manual and the automated inoculation methods.

#### b. Linearity/assay reportable range:

Not applicable

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

The FDA and CLSI recommended quality control (QC) isolate, S. aureus ATCC 29213 was tested each day of the challenge and clinical study testing with the reference method and with the BD Phoenix System. The inocula were standardized using both the automated (Phoenix AP) and manual (PhoenixSpec) methods. A sufficient number of tests were performed and all quality control results for the BD Phoenix fell within the acceptable ranges demonstrating that the BD Phoenix System can consistently produce quality control results in the recommended range for Ceftaroline.

Quality control testing of the BD Phoenix – Ceftaroline was conducted to demonstrate that acceptable results were achieved &gt;95% of the time by both auto-dilution and manual dilution inoculum preparation methods.

Table 3 Summary of Quality Control Results – BD Phoenix Ceftaroline

|  ORGANISM | Ceftaroline (μg/mL) | Reference | Auto-Dilution (Phoenix™ AP) | Reference | Manual Dilution (Phoenix Spec™)  |
| --- | --- | --- | --- | --- | --- |
|  S. aureus ATCC 29213 0.12-0.5 μg/mL | ≤0.0625 |  |  |  |   |
|   |  0.125 |  |  |  |   |
|   |  0.25 | 76 | 47 | 79 | 32  |
|   |  0.5 | 1 | 36 | 1 | 85  |
|   |  1 |  |  |  |   |
|   |  2 |  |  |  |   |
|   |  4 |  |  |  |   |
|   |  >4 |  |  |  |   |

The quality control (QC) results with S. aureus ATCC 29213 were within the expected range &gt;95% of the time but an upward MIC trend of BD Phoenix was observed compared to the reference method. For the manual dilution (the primary method used in the clinical study) almost 99% of the QC reference MIC results are at 0.25μg/mL, while 72% of the BD Phoenix manual dilution QC results are at 0.5μg/mL. For the auto dilution: 98.7% of the QC reference MIC results are at 0.25μg/mL, while 43.4% of the BD Phoenix auto-dilution QC results are at 0.5μg/mL

Growth Failure Rate: The overall growth rate during the clinical studies was 99.7%; this meets the acceptance criteria of ≤10% non-growth of organisms tested.

Purity Check Plates: Purity check plates were inoculated from the standardized organism suspensions for both the Phoenix and reference methods. Any isolate that showed mixed growth on the purity check plate was considered noncompliant and not included in result analysis.

Inoculum Density Control: The BD PhoenixSpec™ Nephelometer was used to prepare the inocula for testing of the clinical, challenge, reproducibility and QC

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isolates. The same inoculum suspension was used for both the Phoenix System and the reference method testing. The BD Phoenix AP instrument was used to standardize the inocula for challenge, QC, and reproducibility isolates. Validation data for both the PhoenixSpec™ and the Phoenix™ AP instrument was provided and found to be acceptable.

d. Detection limit:

Not applicable

e. Analytical specificity:

Not applicable

f. Assay cut-off:

Not applicable

2. Comparison studies:

a. Method comparison with predicate device:

The accuracy of results obtained with the Phoenix System was determined by comparison to the CLSI-recommended broth dilution method (reference method). Reference panels were prepared according to CLSI M07-A8 guidelines. Sites performed testing on gram-positive isolates using Phoenix and reference panel formats appropriate for gram positive organisms. Antimicrobial agents in the test and reference panels had identical dilution ranges which were appropriate for the interpretive breakpoints of the drug. Testing was performed using at least two different production lots of Phoenix panels, AST broth and AST indicator at each study site. A minimum of three different lots of the Phoenix panel were used across all sites for the entire study. Phoenix and reference panels were inoculated using the same organism suspension.

Growth in the Phoenix panels was determined from data recorded by the instrument. Performance was analyzed using FDA breakpoints for Ceftaroline, and results were compared to results obtained by the broth microdilution reference method based on the guidelines provided in the Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems.

A total of 830 clinical isolates were tested at the three study sites and included both fresh and stock isolates (413 MRSA, 405 MSSA and 12 S. aureus isolates for which methicillin susceptibility or resistance was not characterized). Stock isolates comprised 6.5% of total isolates tested. Clinical isolates tested included representatives of species listed in the FDA approved pharmaceutical drug label. Clinical isolates were tested using inocula prepared using the PhoenixSpec

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nephelometer (manual method).

A challenge set of isolates were supplied to the testing sites by the sponsor. Challenge isolates were obtained from BD's internal collection and from external laboratories. Results obtained for challenge isolates using the Phoenix System were compared to expected MIC results; expected MIC values and categorical interpretations were derived from testing with multiple lots of reference broth dilution panels over a three-month period. The challenge set was divided into subsets and an individual subset was distributed to each of the three study sites. Identification and expected results were masked to the study sites. The inocula for the challenge isolates were prepared using both the PhoenixSpec nephelometer (manual method) and the Phoenix AP (automated method).

The performance evaluation summary of essential and categorical agreement results for clinical, and challenge isolates with inocula prepared using the PhoenixSpec nephelometer (manual method) is shown in the Tables 4 and 5 below.

Table 4 BD Phoenix Ceftaroline (PhoenixSpec Nephelometer - Manual Inoculum Prep)

|   | Tot | EA N | % EA | Total Eval | EA Eval N | %EA Eval | CA N | % CA | #R | min | maj | vmj  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  S.aureus |  |  |  |  |  |  |  |  |  |  |  |   |
|  Clinical | 830 | 786 | 94.7 | 821 | 781 | 95.1 | 815 | 98.2 | 0 | 15 | 0 | 0  |
|  Challenge | 36 | 34 | 94.4 | 36 | 34 | 94.4 | 35 | 97.2 | 0 | 1 | 0 | 0  |
|  Combined | 866 | 820 | 94.7 | 857 | 815 | 95.1 | 850 | 98.2 | 0 | 16 | 0 | 0  |

EA-Essential Agreement

CA-Category Agreement

R-resistant isolates

maj-major discrepancies

vmj-very major discrepancies

min-minor discrepancies

Essential agreement (EA) is when the BD Phoenix™ panels agree with the reference test panel results exactly or within one doubling dilution of the reference method. Category agreement (CA) is when the BD Phoenix™ panel result interpretation agrees exactly with the reference panel result interpretation. Evaluable EA is when the MIC result is on scale for both the BD Phoenix™ and the reference and have on-scale EA.

Table 5 BD Phoenix Ceftaroline Stratified by Group (PhoenixSpec Nephelometer-Manual Inoculum Prep)

|   | EA TOT | EA N | EA % | Eval EA Tot | Eval EA N | Eval EA % | CA N | CA % | #R | min | maj | vmj  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  S. aureus MRSA  |   |   |   |   |   |   |   |   |   |   |   |   |
|  Clinical | 413 | 396 | 95.9 | 413 | 396 | 95.9 | 398 | 96.4 | 0 | 15 | 0 | 0  |
|  Challenge | 23 | 23 | 100 | 23 | 23 | 100 | 22 | 95.7 | 0 | 1 | 0 | 0  |
|  Combined | 436 | 419 | 96.1 | 436 | 419 | 96.1 | 420 | 96.3 | 0 | 16 | 0 | 0  |
|  S. aureus MSSA  |   |   |   |   |   |   |   |   |   |   |   |   |
|  Clinical | 405 | 379 | 93.6 | 399 | 376 | 94.2 | 405 | 100 | 0 | 0 | 0 | 0  |
|  Challenge | 13 | 11 | 84.6 | 13 | 11 | 84.6 | 13 | 100 | 0 | 0 | 0 | 0  |
|  Combined | 418 | 390 | 93.3 | 412 | 387 | 93.9 | 418 | 100 | 0 | 0 | 0 | 0  |
|  S. aureus (MRSA and MSSA combined)  |   |   |   |   |   |   |   |   |   |   |   |   |
|  Clinical | 830* | 786 | 94.7 | 821 | 781 | 95.1 | 815 | 98.2 | 0 | 15 | 0 | 0  |

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|  Challenge | 36 | 34 | 94.4 | 36 | 34 | 94.4 | 35 | 97.2 | 0 | 1 | 0 | 0  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  Combined | 866* | 820 | 94.7 | 857 | 815 | 95.1 | 850 | 98.2 | 0 | 16 | 0 | 0  |

*Data includes 12 isolates of S. aureus for which methicillin susceptibility or resistance was not characterized.

For the clinical and challenge organism testing performed for Ceftaroline using the BD Phoenix, the overall % EA and % CA consistently met the acceptance criteria of greater than or equal to 90%. Overall, there were no major or very major categorical errors and a total of 16 minor errors. There was only one Ceftaroline intermediate isolate (i.e. MRSA) tested in the challenge testing. This is insufficient to evaluate the ability of the Phoenix to detect Ceftaroline non-susceptible Staphylococcus aureus. The following limitation was included in the labeling (Limitations, Section 6.2 Package Insert for Phoenix GP Panels):

"The ability of the Phoenix System to detect nonsusceptibility in the following combination(s) is unknown because a sufficient number of nonsusceptible strains were not encountered at the time of comparative clinical testing: Ceftaroline-Staphylococcus aureus".

Using the data provided by the sponsor in the diagonal table format recommended in the AST Guidance, an analysis was conducted to check for any trending in MIC values. Of the 866 isolates tested, there were 857 on-scale MIC results. The data demonstrated that there was a significant upward trending in the MIC of BD Phoenix compared to the reference method. There were 29.5% (253/857) of the BD Phoenix™-Ceftaroline results equal to the reference method, 65.1% (558/857) of the BD Phoenix™-Ceftaroline were higher by one doubling dilution, and 5% (40/857) were higher by two doubling dilutions; there was only 0.5% (4/857) BD Phoenix™-Ceftaroline results that were one doubling dilution lower than the reference method. The performance data demonstrated an upward trending (69.8%, 598/857) even though within a good EA of 97.2%.

This significant trending and the potential for occurrence of major error(s) for Ceftaroline when testing S. aureus particularly if this occurs with isolates with MIC values around the breakpoint was addressed in labeling. The following footnote was recommended to be included in the Performance Characteristics section of the labeling:

"BD Phoenix MIC values tended to be higher by one dilution compared to reference broth micro-dilution. Staphylococcus aureus with an interpretation of 'resistant' for ceftaroline is uncommon in most institutions or may result from technical errors. Verify ID/AST if this phenotype has not been previously encountered from this patient or institution".

The overall growth rate for all species combined was 99.7%; this meets the acceptance criteria of ≤ 10% non-growth of organisms tested.

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The two methods of inoculations were evaluated in the Reproducibility, QC, and Challenge studies. Suspensions were prepared using both the PhoenixSpec nephelometer (manual method) and the Phoenix AP instrument (automated method). A comparison of the performance of the two standardization methods for the challenge study is illustrated in Table 6 below:

Table 6 Comparison of Challenge Isolate Inoculation Standardization Methods

|   | EA TOT | EA N | EA % | Eval EA Tot | Eval EA N | Eval EA % | CA N | CA % | #R | min | maj | vmj  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  S. aureus MRSA  |   |   |   |   |   |   |   |   |   |   |   |   |
|  Phoenix Spec (Manual) | 23 | 23 | 100 | 23 | 23 | 100 | 22 | 95.7 | 0 | 1 | 0 | 0  |
|  Phoenix AP (Auto) | 23 | 23 | 100 | 23 | 23 | 100 | 21 | 91.3 | 0 | 2 | 0 | 0  |
|  S. aureus MSSA  |   |   |   |   |   |   |   |   |   |   |   |   |
|  Phoenix Spec (Manual) | 13 | 11 | 84.6 | 13 | 11 | 84.6 | 13 | 100 | 0 | 0 | 0 | 0  |
|  Phoenix AP (Auto) | 13 | 12 | 92.3 | 13 | 12 | 92.3 | 13 | 100 | 0 | 0 | 0 | 0  |
|  S. aureus (MRSA and MSSA combined)  |   |   |   |   |   |   |   |   |   |   |   |   |
|  Phoenix Spec (Manual) | 36 | 34 | 94.4 | 36 | 34 | 94.4 | 35 | 97.2 | 0 | 1 | 0 | 0  |
|  Phoenix AP (Auto) | 36 | 35 | 97.2 | 36 | 35 | 97.2 | 34 | 94.4 | 0 | 2 | 0 | 0  |

For the challenge organisms tested using suspensions prepared with either the manual (PhoenixSpec) method or using the Phoenix AP instrument, the overall % EA and % CA consistently met the acceptance criteria of greater than or equal to 90%. There were 2 minor errors with inocula prepared using the Phoenix AP instrument, and 1 minor errors with inocula prepared using the PhoenixSpec. There were no very major errors or major categorical errors with either inoculation method.

b. Matrix comparison:

Not applicable

3. Clinical studies:

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

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4. Clinical cut-off:
Not applicable

5. Expected values/Reference range:

The MIC interpretive criteria are illustrated in Table 7 below.

Table 7 MIC Interpretive Criteria
|  Organism | Ceftaroline - Susceptibility Interpretive Criteria (MIC in μg/mL)  |   |   |
| --- | --- | --- | --- |
|   | S | I | R  |
|  S. aureus | ≤ 1 | 2 | ≥ 4  |

N. Proposed Labeling:

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

O. Conclusion:

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

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON/K140468](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/LON/K140468)

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