← Product Code [JTN](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/JTN) · K112586

# CEFTAROLINE 30 MICROGRAMS, BBL(TM) SENSI-DISC(TM) (K112586)

_Becton, Dickinson and Company (BD) · JTN · Oct 18, 2011 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/JTN/K112586

## Device Facts

- **Applicant:** Becton, Dickinson and Company (BD)
- **Product Code:** [JTN](/submissions/MI/subpart-b%E2%80%94diagnostic-devices/JTN.md)
- **Decision Date:** Oct 18, 2011
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.1620
- **Device Class:** Class 2
- **Review Panel:** Microbiology

## Intended Use

Antimicrobial Susceptibility Test Disks are used for semi-quantitative in vitro susceptibility testing by standardized agar diffusion test procedures. Ceftaroline 30μg BBL™ Sensi-Disc™ is intended for use in determining the susceptibility to Ceftaroline of a wide range of bacterial pathogens.

## Device Story

Device consists of high-quality paper disks impregnated with 30µg of Ceftaroline. Used in clinical microbiology laboratories for semi-quantitative in vitro susceptibility testing via agar diffusion (Bauer-Kirby method). Disks are placed on inoculated Mueller Hinton Agar (or supplemented media for specific organisms). Following incubation, healthcare providers measure zones of inhibition surrounding disks. Measured diameters are compared against established zone size ranges from FDA-approved drug inserts and CLSI/NCCLS standards (M2, M100) to categorize isolates as susceptible, intermediate, or resistant. Results assist clinicians in selecting appropriate antimicrobial therapy for patients with bacterial infections.

## Clinical Evidence

No clinical diagnostic studies were performed for this device. Performance is supported by clinical outcome studies conducted by the drug manufacturer for Ceftaroline approval, which established the interpretive criteria and quality control ranges used for disk diffusion testing.

## Technological Characteristics

High-quality paper disks impregnated with 30μg Ceftaroline. Principle: Agar diffusion (Bauer-Kirby). Test medium: Mueller Hinton Agar (or supplemented variants). Standardized via CLSI M02-A10 and M100. Manual measurement of inhibition zones.

## Regulatory Identification

An antimicrobial susceptibility test disc is a device that consists of antimicrobic-impregnated paper discs used to measure by a disc-agar diffusion technique or a disc-broth elution technique the in vitro susceptibility of most clinically important bacterial pathogens to antimicrobial agents. In the disc-agar diffusion technique, bacterial susceptibility is ascertained by directly measuring the magnitude of a zone of bacterial inhibition around the disc on an agar surface. The disc-broth elution technique is associated with an automated rapid susceptibility test system and employs a fluid medium in which susceptibility is ascertained by photometrically measuring changes in bacterial growth resulting when antimicrobial material is eluted from the disc into the fluid medium. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.

## Predicate Devices

- Other BBL™ Sensi-Disc™ (e.g., Ciprofloxacin 5 µg, BBL™ Sensi-Disc™)

## 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:
K112586

B. Purpose for Submission:
To obtain a substantial equivalent determination for the Ceftaroline 30μg, BBL Sensi-Disc™ Antimicrobial Susceptibility Test Disks.

C. Measurand:
Ceftaroline 30μg

D. Type of Test:
Semi-quantitative Antimicrobial Susceptibility Test Disc

E. Applicant:
Becton Dickinson and Company

F. Proprietary and Established Names:
Ceftaroline 30μg BBL™ Sensi -Disc™ Antimicrobial Susceptibility Test Disks

G. Regulatory Information:

|  Product Code | Classification | Regulation Section | Panel  |
| --- | --- | --- | --- |
|  JTN | II | 866.1620 | 83 Microbiology  |

H. Intended Use:

1. Intended use(s):
Antimicrobial Susceptibility Test Disks are used for semi-quantitative in vitro susceptibility testing by standardized agar diffusion test procedures. Ceftaroline 30μg BBL™ Sensi-Disc™ is intended for use in determining the susceptibility to Ceftaroline of a wide range of bacterial pathogens.

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2. Indications for use:

Use of Ceftaroline 30μg BBL™ Sensi-Disc™ for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to Ceftaroline. The concentration of 30μg has been shown to be active in vitro against most strains of microorganisms listed below, as described in the FDA approved drug insert for this antimicrobial agent

|  Active In Vitro and in Clinical Infections Against:  |   |
| --- | --- |
|  Gram-positive Microorganisms
Staphylococcus aureus
(including methicillin-susceptible and -resistant isolates)
Streptococcus pyogenes
Streptococcus agalactiae
Streptococcus pneumoniae | Gram-negative Microorganisms
Escherichia coli
Klebsiella pneumoniae
Klebsiella oxytoca
Haemophilus influenzae  |
|  Active In Vitro Against:  |   |
|  Gram-positive Microorganisms
Streptococcus dysgalactiae | Gram-negative Microorganisms
Citrobacter koseri
Citrobacter freundii
Enterobacter cloacae
Enterobacter aerogenes
Moraxella catarrhalis
Morganella morganii
Proteus mirabilis
Haemophilus parainfluenzae  |

3. Special conditions for use statement(s):

For prescription use only.

4. Special instrument requirements:

None

I. Device Description:

Ceftaroline 30μg BBL™ Sensi-Disc™ is prepared by impregnating high quality paper with accurately determined amounts of Ceftaroline supplied by the drug manufacturer. Each Ceftaroline disk is clearly marked on both sides with the agent and drug content. Ceftaroline cartridges each contain 50 impregnated disks that are packed as either a single cartridge in a single box, or in a package containing ten cartridges. Ceftaroline disks are used for semi-quantitative in vitro susceptibility evaluations by the agar diffusion test method.

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Agar diffusion susceptibility methods employing dried filter paper disks impregnated with specific concentrations of antimicrobial agents were developed. Mueller Hinton Agar was selected as the test medium and a standardized procedure was developed.

## J. Substantial Equivalence Information:

1. Predicate device name(s):

Ciprofloxacin 5μg, BBL™ Sensi-Disc™ Antimicrobial Susceptibility Test Disk.

2. Predicate 510(k) number:

K874425

3. Comparison with predicate:

|  Similarities  |   |   |
| --- | --- | --- |
|  Item | Device | Predicate  |
|  Intended Use | An in vitro diagnostic product for clinical susceptibility testing of aerobic gram positive and gram negative bacteria | same  |
|  Inoculum | Prepared from pure isolated colonies using the direct inoculation method or growth method | same  |
|  Inoculation method | Directly equated to a 0.5 McFarland turbidity standard | same  |

Difference

|  Item | Device | Predicate  |
| --- | --- | --- |
|  Antibiotic | Ceftaroline | Ciprofloxacin  |
|  Concentration | 30μg | 5μg  |

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

CLSI M02-A10 January 2009 "Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard. "CLSI M100, "Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard". The Center for Drug Evaluation and Review (CDER) pharmaceutical

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approved package insert, developed during clinical trial studies, was used for Interpretive Criteria and Quality Control (QC) Expected Ranges.

## L. Test Principle:

Disks containing a wide variety of antimicrobial agents are applied to the surface of Mueller Hinton Agar plates [or Haemophilus Test Medium Agar for Haemophilus influenzae or Mueller Hinton Agar with 5% Sheep Blood for Streptococcus species] inoculated with pure cultures of clinical isolates (Bauer-Kirby method). Following incubation, the plates are examined and the zones of inhibition surrounding the disks are measured and compared with established zone size ranges for individual antimicrobial agents in order to determine the agent(s) most suitable for use in antimicrobial therapy. The categorical interpretation [susceptible (S), intermediate (I), or resistant (R)] for the organism being tested with the antimicrobial agent is made by comparing zone diameters to those found in the respective organism tables of FDA drug insert and/or CLSI/NCCLS Document M2 ("Performance Standards for Antimicrobial Disk Susceptibility Tests") and of CLSI/NCCLS Document M100 ("Performance Standards for Antimicrobial Susceptibility Testing").

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

Descriptive characteristics are sufficient for susceptibility test discs, because the drug manufacturer performed several clinical outcome studies enrolling 1300 patients, which were evaluated by FDA Center for Drug Evaluation and Research in order to grant approval of the drug Ceftaroline. These studies generated the Interpretive Criteria and Quality Control Expected Ranges which the antimicrobial susceptibility tests disk manufactures use for interpretation of results also. No additional in vitro diagnostic clinical studies are therefore required.

## 1. Analytical performance:

a. Precision/Reproducibility:

Not applicable

b. Linearity/assay reportable range:

Not applicable

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

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BBL™ Sensi-Disc™ Ceftaroline

|  Zone Diameter Interpretive Chart Quality Control Organisms  |   |   |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  Antimicrobial Agent | Disc Code | Disc Potency | R | I | S | E.coli ATCC™ 25922 | S. aureus ATCC 25923 | P.aeruginosa ATCC 27853  |
|  Ceftaroline | CPT-30 | 30 μg | – | – | ≥ 24 | 26-34 | 26-35 | –  |
|  Staphylococcus aureus
(including methicillin-resistant isolates –
skin isolates only) |  |  | – | – | ≥ 26 |  |  |   |
|  Streptococcus agalactiae
(skin isolates only) |  |  | – | – | ≥ 24 |  |  |   |
|  Streptococcus pyogenes
(skin isolates only) |  |  | – | – | ≥ 27 |  |  |   |
|  Streptococcus pneumoniae
(CABP isolates only) |  |  | – | – | ≥ 33 |  |  |   |
|  Haemophilus influenzae
(CABP isolates only) |  |  | ≤ 19 | 20-22 | ≥ 23 |  |  |   |
|  Enterobacteriaceae
(CABP and skin isolates) |  |  |  |  |  |  |  |   |

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:
Not applicable

b. Matrix comparison:
Not applicable

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3. Clinical studies:

a. Clinical Sensitivity:
Not applicable

b. Clinical specificity:
Not applicable

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

4. Clinical cut-off:
Not applicable

5. Expected values/Reference range:

Staphylococcus aureus ≥ 24mm (S)*
Streptococcus agalactiae ≥ 26mm (S)*
Streptococcus pyogenes ≥ 24mm (S)*
Streptococcus pneumoniae ≥ 27mm (S)*
Haemophilus influenzae ≥ 33mm (S)*
Enterobacteriaceae ≥ 23 mm (S) 20-22 mm (I) ≤ 19 mm (R)

S = susceptible, I = intermediate, R = resistant

* The current absence of resistant isolates precludes defining any results other than "Susceptible". Isolates yielding MIC or disk diffusion results suggestive of "Nonsusceptible" should be subjected to additional testing.

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/JTN/K112586](https://fda.innolitics.com/submissions/MI/subpart-b%E2%80%94diagnostic-devices/JTN/K112586)

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