ETEST TOBRAMYCIN 0.016-256 UG/ML AND 0.064-1024 UG/ML

K102668 · BIOMERIEUX · JWY · Nov 17, 2010 · Microbiology

Device Facts

• Record ID: K102668
• Device Name: ETEST TOBRAMYCIN 0.016-256 UG/ML AND 0.064-1024 UG/ML
• Applicant: BIOMERIEUX
• Product Code: JWY · Microbiology
• Decision Date: Nov 17, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1640
• Device Class: Class 2

Intended Use

This submission is for Etest® Tobramycin for MIC determinations across 0.016-256 ug/ml. and 0.064-1024 ug/mL vith Staphylowouns aureus, Enterbacteriareae and P. aerweinosa. Etest® is a quantitative technique for determination of antimicrobial susceptibility of both nonfastidious Gram negative and Gram posstive aerobic bacteria such as Enterbacteriateae. Pseudomonas, Staphylococus and Entervocus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptorocus 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 Story

Etest® is a manual, quantitative antimicrobial susceptibility test (AST) system. It consists of a 5mm x 60mm inert, non-porous plastic strip containing a predefined, stable, exponential gradient of dried antibiotic. The strip is applied to an inoculated agar plate; the antibiotic diffuses into the agar, creating a concentration gradient. Following overnight incubation, a symmetrical inhibition ellipse forms around the strip. The clinician reads the MIC value where the ellipse edge intersects the strip. This quantitative result assists healthcare providers in determining appropriate antibiotic therapy for bacterial infections. The device is intended for use in clinical microbiology laboratories by trained personnel.

Clinical Evidence

Performance evaluated using 1,300 isolates (1,075 clinical/stock, 225 challenge) across three sites. Compared to CLSI reference broth microdilution and agar dilution methods. Combined results showed 98.8% Essential Agreement (EA) and 97.5% Category Agreement (CA). No very major or major errors were observed. Reproducibility study at three sites demonstrated 96.0%–98.7% agreement within +/- one doubling dilution.

Technological Characteristics

Quantitative gradient diffusion strip. Predefined antibiotic concentration gradient (0.016-256 ug/mL and 0.064-1024 ug/mL). Manual application to agar plates. Requires overnight incubation. No electronic components or software.

Indications for Use

Indicated for determination of antimicrobial susceptibility of S. aureus, Enterobacteriaceae, and P. aeruginosa to Tobramycin. Used for MIC determination across concentrations of 0.016 - 256 μg/mL and 0.064 - 1024 μg/mL.

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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Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

BIOMÉRIEUX c/o Ms. Asa Karlsson Regulatory Affairs Manager 5, rue des Aqueducs 69290 Craponne, France

NOV 1 7 2010

Re: K102668

Trade/Device Name: Etest Tobramycin for Antimicrobial Susceptibility Test Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test (AST) Powder Regulatory Class: Class II Product Code: JWY Dated: September 17, 2010 Received: September 16, 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 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 class II (Special Controls), 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

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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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 advice for your device on our labeling regulation (21 CFR Parts 801 and 809), 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" (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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jayanand

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

Enclosure

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## Indications For Use

510(k) Number: K102668

Device Name: Etest® Tobramycin - Antimicrobial Susceptibility Test - MIC at 0.016-256 ug/mL and 0.064-1024 ug/mL.

Indications For Use: This submission is for Etest® Tobramycin for MIC determinations across 0.016-256 ug/ml. and 0.064-1024 ug/mL vith Staphylowouns aureus, Enterbacteriareae and P. aerweinosa.

Etest® is a quantitative technique for determination of antimicrobial susceptibility of both nonfastidious Gram negative and Gram posstive aerobic bacteria such as Enterbacteriateae. Pseudomonas, Staphylococus and Entervocus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptorocus 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.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

K102668

NOV 1 7 2010

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

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

Freddie McCoole
Division Sign Off

Vision Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k)