ETEST FOR GEMIFLOXACIN by AB BIODISK

Etest is a quantitative technique for the determination of antimicrobial susceptibility of both nonfastidious Gram negative and Gram positive aerobic bacteria, such as Enterobacteriaxeae, Pseudomonas, Staphylooocus and Enteroous species and fastidious bacteria, such as anaerobes, Pneumooocus, Streptocous, Gonocous and Haemophilus species. The system comprises a predefined antibiotic gradient that is used to determine the minimum inhibitory concentration (MIC) in µg/ml of individual antibiotics against bacteria as tested on agar media by overnight incubation.

This 510(k) submission is for an additional drug for Etest for MIC determination of Gemifloxacin MIC 0.002 - 32 µg/ml with Enterobacteriaceae, S. pneumoniae and H. influenzae.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification decision letter from the FDA for the Etest® Gemifloxacin 0.002-32 µg/mL. This document is a regulatory approval, and as such, it does not contain the detailed study information required to answer the prompt.

Specifically, the document does not include:

A table of acceptance criteria and reported device performance.
Sample sizes or data provenance for a test set.
Information on experts used to establish ground truth or their qualifications.
Adjudication methods.
Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
Results of a standalone algorithm performance study.
The type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

The letter explicitly states: "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..." This means the device was approved based on its substantial equivalence to a predicate device, not necessarily on a new, comprehensive study detailed within this document. The "Indications for Use" section further clarifies that the submission is "for an additional drug for Etest for MIC determination of Gemifloxacin MIC 0.002 - 32 µg/ml with Enterobacteriaceae, S. pneumoniae and H. influenzae."

To obtain the requested information, one would need to refer to the full 510(k) submission document (K042390) itself, which would contain the study results and details that supported the substantial equivalence claim.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 1 9 2004

Ms. Anne Bolmström President & CEO AB Biodisk Dalvägen 10 S-169 56 Solna Sweden

K042390 Re: Trade/Device Name: Etest® Gemifloxacin 0.002-32 µg/mL Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: JWY Dated: November 10, 2004 Received: November 12, 2004

Dear Ms. Bolmström:

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 such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Salartys

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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Indications for Use

510(k) Number (if known): K042390

Device Name: Etest® Gemifloxacin 0.002-32 µg/mL

Indications For Use:

For in vitro diagnostic use:

This 510(k) submission is for an additional drug for Etest for MIC determination of Gemifloxacin MIC 0.002 - 32 µg/ml with Enterobacteriaceae, S. pneumoniae and H. influenzae.

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)

Ludolfo-Rocle

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K^{04}23^{D} Si

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C:\Documents and Settings\MBB\Desktop\O\VD\Review AST 510K\AB Biodisk[K042390](https://510k.innolitics.com/search/K042390) gemifloxacin\IFU 0410-1.00C

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).