TRIMETHOPRIM/SULPHAMETHOXAZOLE (1/19)

K990685 · Ab Biodisk · JWY · Mar 26, 1999 · Microbiology

Device Facts

• Record ID: K990685
• Device Name: TRIMETHOPRIM/SULPHAMETHOXAZOLE (1/19)
• Applicant: Ab Biodisk
• Product Code: JWY · Microbiology
• Decision Date: Mar 26, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1640
• Device Class: Class 2

Intended Use

Etest is a quantitative technique for the 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, Pneumococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which 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 Etest 510(k) application is for MIC determination of Trimethoprim/Sulphamethoxazole (1/19) in the range of 0.002 - 32 µg/ml with S. pneumoniae. Previously cleared applications for Trimethoprim/Sulphamethoxazole (1/19) are nonfastidious Gram negative and Gram positive aerobic bacteria and H. influenzae.

Device Story

Etest is a quantitative in vitro diagnostic device for determining antimicrobial susceptibility; utilizes a predefined antibiotic gradient on a test strip; applied to agar media inoculated with bacterial samples; incubated overnight; MIC value determined by observing the intersection of the bacterial growth inhibition zone with the strip gradient; used in clinical laboratories by trained personnel; provides MIC values to guide antibiotic therapy selection; benefits patients by enabling targeted antimicrobial treatment.

Clinical Evidence

No clinical data provided; device relies on bench testing for MIC determination performance.

Technological Characteristics

In vitro diagnostic test strip with predefined antibiotic gradient; manual application to agar media; requires overnight incubation; provides quantitative MIC results.

Indications for Use

Indicated for in vitro diagnostic use to determine antimicrobial susceptibility (MIC) of S. pneumoniae to Trimethoprim/Sulphamethoxazole (1/19) in the range of 0.002 - 32 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 2098 Gaither Road Rockville MD 20850

MAR 26 1999

Anne Bolmström President AB BIODISK Dalvägen 10 S-169 56 Solna Sweden

K990685 Re:

Trade Name: Etest® for Trimethoprim/Sulphamethoxazole Regulatory Class: II Product Code: JWY Dated: February 26, 1999 Received: March 3, 1999

Dear Ms. Bolmström:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a Iegally 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 Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number [phone] or at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Autman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: Etest® for Trimethoprim/Sulphamethoxazole

Indications For Use:

球比分

For in vitro diagnostic use:

Etest is a quantitative technique for the 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, Pneumococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which 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 Etest 510(k) application is for MIC determination of Trimethoprim/Sulphamethoxazole (1/19) in the range of 0.002 - 32 µg/ml with S. pneumoniae.

Previously cleared applications for Trimethoprim/Sulphamethoxazole (1/19) are nonfastidious Gram negative and Gram positive aerobic bacteria and H. influenzae.

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

> RH, Office of Device Evaluation (ODE) Concurrence

Woody Dubois

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K990685

Prescription Use X (Per 21 CFR 801.109) OR

Over-The Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)