SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES

K092445 · Trek Diagnostic Systems, Ltd. · JWY · Dec 16, 2009 · Microbiology

Device Facts

• Record ID: K092445
• Device Name: SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES
• Applicant: Trek Diagnostic Systems, Ltd.
• Product Code: JWY · Microbiology
• Decision Date: Dec 16, 2009
• 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 positive and gram negative organisms.

Device Story

Sensititre Susceptibility System performs antimicrobial susceptibility testing (AST) via micro-broth dilution. Input: pure culture bacterial isolates suspended in Mueller-Hinton broth (0.5 McFarland turbidity). Process: 50μl inoculum transferred to dried microtitre plates containing antimicrobial agents; incubated 18-24 hours at 34-36°C. Detection: bacterial growth monitored via fluorescence (surface enzyme activity) or manual turbidity. Output: Minimum Inhibitory Concentration (MIC) and interpretive criteria (SIR). Used in clinical labs; operated by technicians. Results assist clinicians in selecting appropriate antibiotic therapy for patients with bacterial infections.

Clinical Evidence

No clinical data provided. The submission relies on bench testing to demonstrate the performance of the Sensititre system with the addition of Minocycline for the specified organisms.

Technological Characteristics

Micro-broth dilution in dried microtitre plates. Sensing principle: fluorescence detection of bacterial surface enzyme activity (cleavage of fluorogenic substrate) or manual turbidity. Energy source: electrical (AutoReader/AutoInoculator). Connectivity: standalone or integrated with AutoReader. Sterilization: not specified. Software: automated reading algorithm.

Indications for Use

Indicated for susceptibility testing of aerobic and facultative Gram-negative (E. coli, Klebsiella spp., Enterobacter aerogenes, Acinetobacter spp.) and Gram-positive (Staphylococcus aureus) microorganisms using Minocycline (0.03-32μg/mL). Prescription use only. Not indicated for staphylococcal infection treatment.

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

• Siemens' MicroScan®, Dried Gram-Negative and Gram-Positive MIC/Combo Panels (K010159)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - (USA)" arranged around the perimeter. Inside the circle is a stylized graphic of three wavy lines, resembling a bird in flight or a flowing ribbon. The logo is black and white.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

DEC 1 6 2009

Cynthia Knapp Director Lab Services TREK Diagnostics Systems, Inc., 982 Keynote Circle, Suite 6 Cleveland, OH 44131

Re: K092445

Trade/Device Name: Sensititre 18-24 hour Susceptibility Plates Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Test Powder Regulatory Class: Class II Product Code(s): JWY LRG Dated: July 30, 2009 Received: August 10, 2009

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 class II (Special Controls), 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.

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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); medical device reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 advice for your device on our labeling regulation (21 CFR Parts 801 and 809), 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" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours.

Vais astyn

Sally A. Hojvat, Ph.D. Director, Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

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## Indications for Use

510(k) Number (if known): Koga 445

Device Name: The "Sensititre® 18 - 24 hour MIC or Breakpoint Susceptibility System" with Minocycline (0.03 - 32ug/ml) for Gram Negative and Gram Positive's

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 positive and gram negative organisms.

This 510(k) is for addition of Minocycline in the dilution range of 0.03 - 32μg/ml for testing gram negative and gram positive isolates on the Sensititre® 18 - 24 hour Susceptibility system. The approved primary "Indications for Use" and clinical significance of Minocycline is for:

Aerobic and facultative Gram-negative and Gram-positive microorganisms:

Escherichia coll Klebsiella spp. Enterobacter aerogenes Acinetobacter spp. Staphylococcus aureus*

*Minocycline is not the drug of choice in the treatment of any type of staphylococcal infection.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Freddie M. Poole

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

C10(k) K092445

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