Etest® is a quantitative technique for determination of antimicrobial susceptibility of both nonfastidious Gram negative and Gram positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus, and Enterococcus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC), in ug/mL, of different antimicrobial agents against microorganisms as tested on agar media using overnight incubation.

This submission is for the addition of the antimicrobial ceftaroline at concentrations of 0.002 – 32 µg/mL to the Etest® products. Ceftaroline has been shown to be active in vitro against most strains of the microorganism listed below, as described in the FDA-approved label for this antimicrobial agent.

Active in vitro and in clinical infections

Skin Infections ·

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

Device Description

Etest is a quantitative technique for determination of antimicrobial susceptibility of both non-fastidious Gram negative and Gram positive aerobic bacteria such as Enterobacteriaceae. Pseudomonas, Staphylococcus, and Enterococcus species and fastidious bacteria, such as anaerobes. N. gonorrhoeae, S. pneumoniae, Streptococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC), in ug/mL, of different antimicrobial agents against microorganisms as tested on agar media using overnight incubation.

This submission is for the addition of the antimicrobial ceftaroline at concentrations of 0.002 – 32 ug/mL to the Etest® products.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the Etest® Ceftaroline device, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (from FDA Guidance Document: Antimicrobial Susceptibility Test (AST) Systems)	Reported Device Performance (Etest® Ceftaroline)
Overall Essential Agreement (EA)	99.8%
Overall Category Agreement (CA)	99.8%
Reproducibility	Acceptable results (details in submission)
Quality Control	Acceptable results (details in submission)

2. Sample Sizes Used for the Test Set and Data Provenance:

Sample Size of Test Set: The document states that an "external evaluation was conducted with fresh and stock clinical isolates, as well as a set of challenge strains" for Staphylococcus aureus. However, the exact number of isolates used in this test set is not explicitly provided in the given text. It mentions "most strains of the microorganism listed below," but not a specific count for the evaluation.
Data Provenance: The document implies the data is prospective as it describes an "external evaluation was conducted." The country of origin is not specified, but the submitter (bioMérieux, Inc.) is based in Hazelwood, MO, USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

The document does not provide information on the number of experts used or their qualifications to establish the ground truth for the test set.

4. Adjudication Method for the Test Set:

The document does not describe an adjudication method. The performance is compared directly against the CLSI broth microdilution reference method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not conducted as per the provided information. This device is an automated in vitro diagnostic test, not a system that assists human readers in interpreting images or data.

6. Standalone Performance:

Yes, a standalone performance evaluation was conducted. The Etest® Ceftaroline's performance (99.8% EA and 99.8% CA) was compared directly against the CLSI broth microdilution reference method, indicating its performance as an algorithm-only (device-only) system.

7. Type of Ground Truth Used:

The ground truth used was the CLSI broth microdilution reference method. This is a recognized standard for determining antimicrobial susceptibility.

8. Sample Size for the Training Set:

The document does not explicitly mention a training set or its sample size. This type of device (antimicrobial susceptibility test) typically relies on biochemical principles and established reference methods rather than a machine learning model that requires a discrete training phase. The "external evaluation" serves as a validation or test set against a known standard.

9. How the Ground Truth for the Training Set was Established:

As a training set is not explicitly mentioned or implied for this type of device, the method for establishing its ground truth is not applicable based on the provided text. The device's performance is validated against a pre-established reference method.

Summary

{0}------------------------------------------------

K121002

OCT 1 2 2012

Image /page/0/Picture/2 description: The image shows the logo for bioMerieux. The logo consists of the word "BIOMERIEUX" in a sans-serif font, with a stylized graphic above it. The graphic is a circle that is bisected by a curved line, with one half of the circle filled with vertical lines.

510(k) SUMMARY

Etest® Ceftaroline

A. 510(k) Submission Information:

Submitter's Name:	bioMérieux, Inc.
Address:	595 Anglum RoadHazelwood, MO 63042
Contact Person:	Jennifer Chia-Hsuan LinRegulatory Affairs Specialist
Phone Number:	314-731-8639
Fax Number:	314-731-8689
Date of Preparation:	March 30, 2012
B. Device Name:
Formal/Trade Name:	Etest® Ceftaroline

Classification Name:

21 CFR 866.1640 Antimicrobial Susceptibility Test (AST) Powder Product Code - JWY

Common Name: Antimicrobial susceptibility test

C. Predicate Device:

D. 510(k) Summary:

Etest® Tobramycin (K102668)

This submission is for the addition of the antimicrobial ceftaroline at concentrations of 0.002 – 32 ug/mL to the Etest® products. Ceftaroline has been shown to be active in vitro against most strains of the microorganism listed below, as described in the FDA-approved label for this antimicrobial agent.

Active in vitro and in clinical infections

Skin Infections

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

Etest Ceftaroline demonstrated substantially equivalent performance when compared with the CLSI broth microdilution reference method, as defined in the FDA Class II Special Controls

bioMérieux, Inc. 595 Anglum Road, Hazelwood, Missouri 63042-2320, USA Phone: 314/731-8500 800/638-4835 Fax: 314/731-8700 · http://www.biomerieux-usa.com Page 85 of 134

{1}------------------------------------------------

Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA. Issued August 28, 2009.

The Premarket Notification (510[k]) presents data in support of Etest® Ceftaroline. An external evaluation was conducted with fresh and stock clinical isolates, as well as a set of challenge strains. The external evaluations were designed to confirm the acceptability of Etest® Ceftaroline by comparing its performance with the CLSI broth microdilution reference method incubated at 16 by officialing to performance information performance of 99.8% overall Essential Agreement (EA) and 99.8% overall Category Agreement (CA) with the reference method for Staphylococcus aureus during the trial. Reproducibility and Quality Control demonstrated acceptable results. Details can be found in the submission.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the top half of the circle. In the center of the logo is a stylized image of an eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center -- WO66-G609 Silver Spring, MD 20993-002

bioMérieux, Inc. c/o Jennifer CH Lin Specialist, Regulatory Affairs 595 Anglum Road Hazelwood, MO 63042

T 12 202

Re: K121002

Trade Name: Etest Ceftaroline (0.002 - 32ug/mL) Regulation Number: 21 CFR §866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: JWY Dated: October 4, 2012 Received: October 5. 2012

Dear Lin:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

{3}------------------------------------------------

Page 2 - Jennifer CH Lin

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sally A. Hojvat

Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use

510(k) Number (if known): K121002

Device Name: Etest® Ceftaroline (0.002 - 32 µg/mL)

Indications For Use:

Active in vitro and in clinical infections

Skin Infections ·

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

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Sagalh
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

(x) k12/002

Page 1 of 1

Regulation Number and Section

§ 866.1640 Antimicrobial susceptibility test powder.

(a)
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.(b)
Classification. Class II (performance standards).