SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES

K024357 · Trek Diagnostic Systems, Inc. · LTT · Mar 17, 2003 · Microbiology

Device Facts

• Record ID: K024357
• Device Name: SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES
• Applicant: Trek Diagnostic Systems, Inc.
• Product Code: LTT · Microbiology
• Decision Date: Mar 17, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1640
• Device Class: Class 2

Intended Use

The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of gram negative and gram positive organisms. This 510(k) is for the addition of Gatifloxacin in the dilution range of 0.008 - 16 µg/ml to the Sensititre 18 - 24 hour MIC panel for testing gram negative isolates. The approved primary "Indications for Use" and clinical significance of Gatifloxacin is for: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis. In vitro data, without clinical correlation is provided for: Acinetobacter lwoffi, Citrobacter koseri, Citrobacter freundii, Enterobacter cloacae, Klebsiella oxytoca, Morganella morganii, Proteus vulgaris

Device Story

Sensititre 18-24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic device used in clinical laboratories. It performs antimicrobial susceptibility testing on gram-negative and gram-positive bacterial isolates. This specific submission adds Gatifloxacin (0.008-16 µg/ml) to the existing panel for gram-negative testing. The system determines the Minimum Inhibitory Concentration (MIC) of the antibiotic against the bacterial isolate. Results are used by clinicians to guide antibiotic therapy selection for patients with bacterial infections. The device provides standardized, automated or manual susceptibility results, assisting in the management of infectious diseases.

Clinical Evidence

No clinical data provided. Performance is supported by in vitro susceptibility testing data comparing the Sensititre system to reference methods for Gatifloxacin against specified gram-negative organisms.

Technological Characteristics

In vitro diagnostic susceptibility test panel. Utilizes broth microdilution methodology to determine MIC. Designed for use with gram-negative and gram-positive organisms. Connectivity and software details not specified.

Indications for Use

Indicated for clinical susceptibility testing of gram-negative and gram-positive organisms using the Sensititre 18-24 hour MIC or Breakpoint Susceptibility System. Specifically for Gatifloxacin testing (0.008-16 µg/ml) against gram-negative isolates including E. coli, K. pneumoniae, and P. mirabilis. In vitro data provided for additional gram-negative species (A. lwoffi, Citrobacter spp., E. cloacae, K. oxytoca, M. morganii, P. vulgaris).

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)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized symbol that resembles three human profiles facing to the right, with flowing lines beneath them.

MAR 1 7 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Cynthia C. Knapp Director of Lab Services Trek Diagnostic Systems, Inc. 982 Keynote Circle. Suite 6 Cleveland, OH 44131

k024357 Re:

> Trade/Device Name: Susceptibility Test Panel Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Regulatory Class: Class II Product Code: LTT Dated: December 27, 2002 Received: December 30, 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 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).

{1}------------------------------------------------

Page 2 -

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

{2}------------------------------------------------

510 (k) Number (If known): ___________________________________________________________________________________________________________________________________________________

Device Name: Susceptibility Test Panel

Indications For Use:

The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of gram negative and gram positive organisms.

This 510(k) is for the addition of Gatifloxacin in the dilution range of 0.008 - 16 µg/ml to the Sensititre 18 - 24 hour MIC panel for testing gram negative isolates. The approved primary "Indications for Use" and clinical significance of Gatifloxacin is for: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis. In vitro data, without clinical correlation is provided for: Acinetobacter lwoffi, Citrobacter koseri, Citrobacter freundii, Enterobacter cloacae, Klebsiella oxytoca, Morganella morganii, Proteus vulgaris

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|---------|
| | |
| <img alt="Signature" src="signature.png"/> | |
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K024357 |
| Prescription Use<br>(Per 21 CFR 801.109 | |

OR
Over-The-Counter Use