ETEST TIGECYCLINE GRAM POSITIVE AND GRAM NEGATIVE AEROBIC BACTERIA, STREPTOCOCCUS SPP. AND ANAEROBIC BACTERIA

K052366 · Ab Biodisk · JWY · Oct 13, 2005 · Microbiology

Device Facts

• Record ID: K052366
• Device Name: ETEST TIGECYCLINE GRAM POSITIVE AND GRAM NEGATIVE AEROBIC BACTERIA, STREPTOCOCCUS SPP. AND ANAEROBIC BACTERIA
• Applicant: Ab Biodisk
• Product Code: JWY · Microbiology
• Decision Date: Oct 13, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1640
• Device Class: Class 2

Intended Use

Tigecycline at 0.016 – 256 µg/mL for in vitro diagnostic use for MIC determination with Gram positive and Gram negative aerobic bacteria, Streptococcus species other than S. pneumoniae, and anaerobic bacteria.

Device Story

Etest® is a quantitative antimicrobial susceptibility testing system. It consists of a predefined antibiotic gradient on a plastic strip. The strip is applied to an inoculated agar plate. During overnight incubation, the antibiotic diffuses into the agar, creating a concentration gradient. The MIC is determined by observing the point where the bacterial growth inhibition ellipse intersects the strip. Used in clinical microbiology laboratories by trained technicians. Results assist clinicians in selecting appropriate antibiotic therapy for patients with bacterial infections.

Clinical Evidence

Bench testing only. The submission demonstrates the performance of the Etest® for Tigecycline by comparing MIC results to established reference methods for the specified bacterial groups.

Technological Characteristics

Quantitative gradient diffusion method. Consists of a plastic strip with a predefined antibiotic concentration gradient. Designed for use on agar media. Manual application and visual reading of MIC values after overnight incubation.

Indications for Use

Indicated for the determination of antimicrobial susceptibility (MIC) of Tigecycline in Gram-positive, S. pneumoniae, and anaerobic bacteria.

Regulatory Classification

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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) of the United States of America. The logo features a stylized eagle with three swooping lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 1 3 2005

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

k052366 Re:

K052300
Trade/Device Name: Etest® Antimicrobial Susceptibility Test – Tigecycline MIC at 0.016-256 Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: JWY Dated: August 24, 2005 Received: August 29, 2005

Dear Ms. Bolmström:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamed the device is substantially equivalent (for the indications ferenced above und have actes negally marketed predicate devices marketed in interstate 10 use stated in the encreativent of the enactment date of the Medical Device Amendments, or to commence provision to May 20, 1978, the excordance with the provisions of the Federal Food, Drug, devices mat have been receasined in quire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r out may, therefore, mainer of the Act include requirements for annual registration, listing of general condors provisions of wactice, 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 your device is elaborized (ove a controls. Existing major regulations affecting your device it may be subject to such additions (CFR), Parts 800 to 895. In addition, FDA can be found in fire announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease of advised that I Drivers and evice complies with other requirements of the Act mall i DA has made a determinations administered by other Federal agencies. You must of any I edital statutes and regainents ancluding, but not limited to: registration and listing (21 Comply with an the Free Feep Parts 801 and 809); and good manufacturing practice CI It I art 807), labeling 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Sale, a 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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## Indications for Use

510(k) Number: K052366

Device Name: Etest® Antimicrobial Susceptibility Test – Tigecycline MIC at 0.016-256 ug/mL.

Indications For Use: This submission is for the addition of Tigeycline to the Etest® Indications For Use. This Submission is for the addition with Gram positive and product range for MIC delemination across of For 200 pg.m. In S. pneumoniae and anaerobic bacteria.

Etest® is a quantitative technique for the determination of antimicrobial susceptibility of Efest® is a quantitative technique for the acterials aerobic bacteria such as both non-fastidious Gran negative and Olain poccus and Entercococus species and
Enterobacteriaceae, Pseudomonas, Staphylococcus and Entercococus species and Enterobacteriatede, I Scadomondo, S. J. gonorrhoeae, S. pneumoniae, fastidious bacteria, such as anaerooss, The system comprises a predefined antibiotic Streptococcus, Haemophilus Species: The Uyeton Institution (MIC) in
gradient which is used to determine the Minimum Instagramiams on tested on agar gradient which is used to determine the Miniman microorganisms as tested on agar using overnight incubation.

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)

Salazar
**Division Sign-Off**

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) Kos 2366

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