SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATE

K031545 · Trek Diagnostic Systems, Inc. · JWY · Jul 16, 2003 · Microbiology

Device Facts

• Record ID: K031545
• Device Name: SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATE
• Applicant: Trek Diagnostic Systems, Inc.
• Product Code: JWY · Microbiology
• Decision Date: Jul 16, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1640
• Device Class: Class 2

Intended Use

The Sensititre ESBL confirmatory test plate is an in vitro diagnostic product for detection of ESBL’s in clinical isolates of Klebsiella pneumoniae, Klebsiella oxytoca and Escherichia coli. Test results can be read either manually or automatically on a Sensititre® ARIS or Autoreader.

Device Story

The ESBL Confirmatory Test Plate is an in vitro diagnostic tool used in clinical laboratories to identify ESBL-producing bacteria. The device utilizes specific antimicrobial concentrations—Ceftazidime and Cefotaxime, both alone and in combination with clavulanic acid—to detect resistance patterns in clinical isolates of K. pneumoniae, K. oxytoca, and E. coli. Testing follows NCCLS M7 reference standards. Results are obtained via manual visual inspection or automated reading using the Sensititre ARIS or Autoreader systems. The output assists clinicians in confirming the presence of ESBLs, which informs antibiotic therapy selection and infection control decisions.

Clinical Evidence

Performance evaluated across three sites using 513 clinical isolates of K. pneumoniae, K. oxytoca, and E. coli compared to NCCLS reference methods. Manual reading showed 97.3% sensitivity and 95.4% specificity. Automated reading showed 98.3% sensitivity and 96.4% specificity. An additional study of 30 molecularly characterized isolates demonstrated 100% agreement for both manual and automated methods.

Technological Characteristics

Microtiter plate format containing dehydrated antimicrobial agents (Ceftazidime, Cefotaxime, and clavulanic acid combinations). Operates via broth microdilution principle. Compatible with Sensititre ARIS or Autoreader for automated optical reading. Complies with NCCLS M7 standards.

Indications for Use

Indicated for the detection of Extended-Spectrum Beta-Lactamases (ESBLs) in clinical isolates of Klebsiella pneumoniae, Klebsiella oxytoca, and Escherichia coli.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter.

JUL 16 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Cynthia C. Knapp Director Lab Services TREK Diagnostic System 982 Keynote Circle, Suite 6 Cleveland, Ohio 44131

k031545 Re:

> Trade/Device Name: ESBL Confirmatory Test Plate Ceftazimdime, Ceftazidime/clavulanic acid, Cefotaxime,

> > Cefotaxime/ clavulanic acid

Regulation Number: 21 CFR 866.1640

Regulation Name: Antimicrobial Susceptibility Test Regulatory Class: Class II Product Code: JWY Dated: May 16, 2003 Received: May 20, 2003

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. Iisting 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 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 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); and good manufacturing practice requirements as set forth 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). 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 Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510 (k) Number (If known):

O31545

Device Name: ESBL Confirmatory Test Plate

Indications For Use:

The Sensititre ESBL confirmatory test plate is an in vitro diagnostic product for detection of ESBL's in clinical isolates of Klebsiella pneumoniae, Klebsiella oxytoca and Escherichia coli. Test results can be read either manually or automatically on a Sensititre® ARIS or Autoreader.

This 510(K) is for ESBL Confirmatory Test Plate for Klebsiella pneumoniae, Klebsiella oxytoca, and Escherichia coli containing the following antimicrobials as per the NCCLS reference standard (M7):

Ceftazimdime: 0.06-128 Ceftazidime/clavulanic acid: 0.06/4-128/4 Cefotaxime: 0.06-64 Cefotaxime/clavulanic acid: 0.06/4-64/4

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | | |
|---------------------------------------------------------------|---------|----------------------|
| Division Sign-Off | 7/10/03 | |
| Office of In Vitro Diagnostic Device<br>Evaluation and Safety | | |
| 510(k) | K031545 | |
| Prescription Use<br>(Per 21 CFR 801.109 | OR | Over-The-Counter Use |