This submission is for Etest® Moxifloxacin for MIC determinations across 0.002-32 µg/mL with B. fragilis, B. thetaiotaomirron, C. perfringens and Peptostreptoroccus spp.

Etest® is a quantitative technique for determination of antimicrobial susceptibility of both non-fastidious Gram negative and Gram positive aerobic bacteria such as Enterobaterianas, Staphylocourus and Entervacus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, Streptowers 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 using overnight incubation.

Device Description

Not Found

AI/ML Overview

This is an FDA 510(k) clearance letter for a medical device (Etest® Moxifloxacin for Antimicrobial Susceptibility Testing, K093604), not a study report. Therefore, the provided text does not contain the acceptance criteria or study details that typically accompany a device performance study.

Here's why and what information is missing:

Acceptance Criteria and Reported Device Performance: This document states the device is "substantially equivalent" to predicate devices, but it does not specify any quantitative performance metrics or acceptance criteria that were used to establish this equivalence. It's a regulatory clearance, not a scientific publication of a study's results.
Sample Size, Data Provenance, Ground Truth, Adjudication, MRMC, Standalone Performance, Training Set details: These are all aspects of a detailed study design and results. The 510(k) letter only confirms the device's clearance for marketing.

To get the information requested, one would typically need to consult a separate document, often referred to in the 510(k) summary as a "clinical study report" or "performance data." This letter itself does not provide those details.

Summary

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Image /page/0/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the department's logo in the center. The logo is a stylized representation of an eagle or bird with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the perimeter of the circle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

AUG 2 5 2010

BIOMÉRIEUX c/o Asa Karlsson Quality and Regulatory Manager Dalvagen 10 Solna Sweden 169 56

Re: K093604

Trade/Device Name: Etest® Moxifloxacin for Antimicrobial Susceptibility Testing Regulation Number: 21 CFR §866.1640 Regulation Name: Antimicrobial susceptibility test powder. - Regulatory Class: Class II Product Code: JWY Dated: July 16, 2010 Received: July 20, 2010

Dear Ms. Karlsson: '

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 market in interestate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendmonts, or 10 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 misbrandiyneand 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 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm11.5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Luddie McCool, M.S.

for

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

Enclosure

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K093604

Indications For Use

510(k) Number (if known):

Device Name: Etest® Moxifloxacin - Antimicrobial Sysceptibility Test - MIC at 0.002-32 ug/mL.

Indications For Use: This submission is for Etest® Moxifloxacin for MIC determinations across 0.002-32 µg/mL with B. fragilis, B. thetaiotaomirron, C. perfringens and Peptostreptoroccus spp.

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use _ (21 CFR 807 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)

Luddie L. Pool+
Division Sign-Off

sion Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) KU9 3604

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).