ETEST CEFDITOREN FOR S. PNEUMONIAE AND H. INFLUENZAE

K021445 · Ab Biodisk · JWY · Jun 6, 2002 · Microbiology

Device Facts

• Record ID: K021445
• Device Name: ETEST CEFDITOREN FOR S. PNEUMONIAE AND H. INFLUENZAE
• Applicant: Ab Biodisk
• Product Code: JWY · Microbiology
• Decision Date: Jun 6, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1640
• Device Class: Class 2

Intended Use

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, Streptococcus, Gonococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the minimum inhibitory concentration (MIC) in ug/ml of individual antibiotics against bacteria as tested on agar media by overnight incubation. This Etest 510(k) application is for MIC determination of Cefditoren in the range of 0.002 - 32 µg/ml with S. pneumoniae (penicillin susceptible strains only) and H. influenzae.

Device Story

Etest is a quantitative antimicrobial susceptibility testing system. It consists of a predefined antibiotic gradient on a carrier strip. The strip is applied to inoculated agar media; incubated overnight. 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 laboratories by trained personnel. Results assist clinicians in selecting appropriate antibiotic therapy for patients with bacterial infections.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing performance characteristics for MIC determination of Cefditoren against specified bacterial strains.

Technological Characteristics

Quantitative antimicrobial susceptibility test; predefined antibiotic gradient strip; agar diffusion method; MIC range 0.002 - 32 µg/ml; manual interpretation of growth inhibition ellipse.

Indications for Use

Indicated for in vitro diagnostic determination of antimicrobial susceptibility (MIC) of S. pneumoniae (penicillin susceptible strains) and H. influenzae to Cefditoren.

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

## 6 2002 JUN

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

Re: k021445 Trade/Device Name: Etest® Cefditoren Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Regulatory Class: Class II Product Code: JWY Dated: April 29, 2002 Received: May 6, 2002

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 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); 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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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 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 Part 801 and v 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrb/dsma/dsmamain.html".

Sincerely yours.

Steven Butman

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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## KO21445 510(k) Number (if known):

Device Name: Etest® Cefditoren Indications For Use:

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, Streptococcus, Gonococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the minimum inhibitory concentration (MIC) in ug/ml of individual antibiotics against bacteria as tested on agar media by overnight incubation.

This Etest 510(k) application is for MIC determination of Cefditoren in the range of 0.002 - 32 µg/ml with S. pneumoniae (penicillin susceptible strains only) and H. influenzae.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The Counter Use _

(Optional Format 1-2-96)

Freddie M. Poole

sion Sign-Off) Division of Clinical 510(k) Number