SENSITITRE 18 - 24 HOURS SUSCEPTIBILITY PLATES

K011803 · Trek Diagnostic Systems, Inc. · JWY · Aug 15, 2001 · Microbiology

Device Facts

• Record ID: K011803
• Device Name: SENSITITRE 18 - 24 HOURS SUSCEPTIBILITY PLATES
• Applicant: Trek Diagnostic Systems, Inc.
• Product Code: JWY · Microbiology
• Decision Date: Aug 15, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1640
• Device Class: Class 2

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 Streptomycin in the concentrations of 1000ug/ml and 2000ug/ml to the Sensititre 18-24 hour MIC panel for use as a Screening Test for High-Level Aminoglycoside Resistance and clinical significance of Streptomycin is for: Enterococcus species.

Device Story

Sensititre 18-24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic device for clinical microbiology laboratories. Device utilizes susceptibility plates containing specific concentrations of antibiotics (Streptomycin 1000 µg/ml and 2000 µg/ml) to determine the minimum inhibitory concentration (MIC) or breakpoint for bacterial isolates. System is used by laboratory technicians to identify high-level aminoglycoside resistance in Enterococcus species. Results assist clinicians in selecting appropriate antibiotic therapy for patients with bacterial infections.

Clinical Evidence

No clinical data provided; device relies on bench testing for performance validation of the susceptibility panel.

Technological Characteristics

In vitro diagnostic susceptibility testing system; utilizes microtiter plates containing dehydrated antibiotic concentrations (Streptomycin 1000 µg/ml and 2000 µg/ml).

Indications for Use

Indicated for clinical susceptibility testing of gram-negative and gram-positive organisms. Specifically used as a screening test for high-level aminoglycoside resistance in Enterococcus species.

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

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## Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 1 5 2001

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

Re: K011803

Trade Name: Sensititre 18 – 24 hours Susceptibility Plates – Streptomycin 1000 µg/ml and 2000 µg/ml

Regulatory Class: II Product Code: JWY Dated: June 11, 2001 Received: June 11, 2001

Dear Ms. Knapp:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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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 1 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): K011803

Device Name: Sensitite 18-24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic Doduct for clinical susceptibility testing of gram negative and gram positive organisms.

Indications For Use:

The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro dispostic The Sellshiffe 18 - 24 mode MIC or Sivan for and gram negative and gram positive organisms.

This 510(k) is for the addition of Streptomycin in the concentrations of 1000ug/ml and This Jroly) is not the Sensititive 18-24 hour MIC panel for use as a Screening Test for High-Lievel 2000pg/th to the Senshifte 18-24 hour MIC panel for use as a solonial and clinical significance of Streptomycin is for: Enterococcus species.

(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 k011803

Prescription Use (Per 21 CFR 801.109

OR

Over-The-Counter Use