SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH SPARFLOXACIN

K983310 · Accumed Intl., Inc. · JTT · Dec 17, 1998 · Microbiology

Device Facts

• Record ID: K983310
• Device Name: SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH SPARFLOXACIN
• Applicant: Accumed Intl., Inc.
• Product Code: JTT · Microbiology
• Decision Date: Dec 17, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1640
• Device Class: Class 2

Intended Use

The Sensititre 18 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 Sparfloxacin in the dilution range of 0.002 - 4 ug/ml to the Sensititre 18 - 24 hour MIC panel for testing non-fastidious gram negative isolates. Sparfloxacin indicated for testing in the approved FDA package insert include Enterobacter cloacae and Klebsiella pneumoniae.

Device Story

Sensititre 18-24 Hour Susceptibility Plates are in vitro diagnostic devices used in clinical laboratories to determine the Minimum Inhibitory Concentration (MIC) or breakpoint susceptibility of gram-negative and gram-positive bacteria. This submission adds the antibiotic Sparfloxacin to the existing panel. The system utilizes microdilution technology where bacterial isolates are inoculated into wells containing varying concentrations of the antimicrobial agent. After 18-24 hours of incubation, growth is assessed to determine susceptibility. Results assist clinicians in selecting appropriate antibiotic therapy for patients with bacterial infections. The device is intended for professional use in clinical laboratory settings.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing of the susceptibility test panel performance.

Technological Characteristics

Microdilution susceptibility test panel; utilizes standardized antimicrobial dilution ranges (0.002 - 4 ug/ml for Sparfloxacin). Designed for non-fastidious gram-negative organisms. Operates via standard laboratory incubation protocols (18-24 hours).

Indications for Use

Indicated for in vitro clinical susceptibility testing of non-fastidious gram-negative organisms, specifically Enterobacter cloacae and Klebsiella pneumoniae, using the Sensititre 18-24 hour MIC panel with Sparfloxacin (0.002 - 4 ug/ml).

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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 17 1998

Cindy C. Knapp Director of Lab Services AccuMed International, Inc. 29299 Clemens Road, Suite 1-K Westlake, OH 44145

Re: K983310 Trade Name: Sensititre 18-24 Hour Susceptibility Plates with Sparfloxacin Regulatory Class: II Product Code: JTT, JWY & LTT Dated: September 8, 1998 Received: September 21, 1998

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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number [phone] or at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely vours.

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): K983310

Device Name: Susceptibility Test Panel

Indications For Use:

The Sensititre 18 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 Sparfloxacin in the dilution range of 0.002 - 4 ug/ml to the Sensititre 18 - 24 hour MIC panel for testing non-fastidious gram Organisms indicated for testing in the approved FDA negative isolates. Sparfloxacin package insert include Enterobacter cloacae and Klebsiella pneumoniae.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Woody Dubois

aboratory Devices

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)