CEFOTAXIME

K020859 · Trek Diagnostic Systems, Inc. · JWY · May 15, 2002 · Microbiology

Device Facts

• Record ID: K020859
• Device Name: CEFOTAXIME
• Applicant: Trek Diagnostic Systems, Inc.
• Product Code: JWY · Microbiology
• Decision Date: May 15, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1640
• Device Class: Class 2

Intended Use

The Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility plate is an in vitro diagnostic product for the susceptibility testing of Streptococcus pneumoniae and Haemophilus influenzae. This 510(k) is for the addition of Cefotaxime in the dilution range of 0.016 - 4 µg/ml to the Sensititre Haemophilus/Streptococcus pneumoniae MIC panel for testing Haemophilus influenzae isolates.

Device Story

Sensititre HP MIC Susceptibility Plates are in vitro diagnostic tools used in clinical laboratories to determine antimicrobial susceptibility of S. pneumoniae and H. influenzae. The device consists of microtiter plates containing dehydrated antimicrobial agents (specifically Cefotaxime) at various concentrations. Clinical laboratory technicians inoculate the plates with patient bacterial isolates; the plates are incubated to allow bacterial growth. The device provides a visual or automated reading of bacterial growth inhibition at specific drug concentrations, resulting in an MIC value. This output assists clinicians in selecting appropriate antibiotic therapy for patients with bacterial infections. The system is intended for professional use in clinical settings.

Clinical Evidence

Bench testing only. The submission relies on performance data demonstrating the accuracy and reproducibility of the Sensititre system in determining MIC values for Cefotaxime against Haemophilus influenzae compared to reference methods.

Technological Characteristics

Microtiter plate format containing dehydrated antimicrobial agents. Principle of operation is broth microdilution for MIC determination. Designed for in vitro diagnostic use in clinical laboratories. No specific materials or software algorithms described beyond standard laboratory diagnostic plate construction.

Indications for Use

Indicated for in vitro susceptibility testing of Streptococcus pneumoniae and Haemophilus influenzae isolates to determine the Minimum Inhibitory Concentration (MIC) of antimicrobial agents, specifically Cefotaxime for Haemophilus influenzae.

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.

Predicate Devices

• Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility Plates (K020859)

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains an image of an eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the top of the circle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## MAY 1 5 2002

Ms. Cynthia C. Knapp Director of Lab Services Trek Diagnostic Systems, Inc. 29299 Clemens Road, Suite 1-K Westlake, OH 44145

Re: k020859

Ro2009
Trade/Device Name: Sensititre™ Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility Plates, Cefotaxime for Haemophilus influenzae Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: JWY Dated: March 15, 2002 Received: March 18, 2002

Dear Ms. Knapp:

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 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/cdrh/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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510 (k) Number (If known):

Device Name: Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility Plates.

Indications For Use:

The Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility plate is an in The Sensiture Haemophilus/Success philants of Streptococcus pneumoniae and Haemophilus influenzae.

This 510(k) is for the addition of Cefotaxime in the dilution range of 0.016 - 4 µgml to the I ins STO(K) is for the addition of Select and moniae MIC panel for testing Streptococcus Sellslutte Haemophilus influenzae isolates. The "Indications for Use" and clinical significance of Cefotaxime is for: Haemophilus Influenzae

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | (Division Sign-Off) |
|---------------|-----------------------------------------|
| | Division of Clinical Laboratory Devices |
| 510(k) Number | K020859 |

| Prescription Use (Per 21 CFR 801.109) | <div style="display:inline-block;">✓</div> |
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OR

| Over-The-Counter Use | |
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