SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES

K984489 · Accumed Intl., Inc. · JWY · Feb 16, 1999 · Microbiology

Device Facts

• Record ID: K984489
• Device Name: SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES
• Applicant: Accumed Intl., Inc.
• Product Code: JWY · Microbiology
• Decision Date: Feb 16, 1999
• 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 Cefdinir in the dilution range of 0.06 - 64 ug/ml to the Sensititre 18 - 24 hour MIC panel for testing non-fastidious gram negative isolates. There are no approved primary "Indications for Use" and the clinical significance of Cefdinir is unknown when evaluating Enterobacteriaceae or any other non-fastidious gram negative rods. In vitro data, without clinical correlation is provided for Citrobacter diversus, Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis. Cefdinir is inactive against Pseudomonas and Enterobacter species.

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 bacteria. This submission adds the antibiotic Cefdinir to existing panels. The device utilizes microdilution technology where bacterial isolates are inoculated into wells containing varying concentrations of antimicrobial agents. After 18-24 hours of incubation, growth is assessed to determine susceptibility. Results are interpreted by laboratory professionals to guide antibiotic selection for patients. The device provides standardized, automated, or manual susceptibility testing to assist clinicians in managing bacterial infections.

Clinical Evidence

Bench testing only. In vitro data provided for Citrobacter diversus, Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis. No clinical correlation or clinical outcome data provided for Cefdinir testing in these organisms.

Technological Characteristics

Microdilution susceptibility test panel. Consists of multi-well plates containing dehydrated or frozen antimicrobial agents (Cefdinir). Operates via broth microdilution principle. Designed for use in clinical laboratory settings. Standardized for 18-24 hour incubation periods.

Indications for Use

Indicated for in vitro susceptibility testing of gram-negative and gram-positive organisms using the Sensititre 18-24 hour MIC panel. Specifically includes testing of non-fastidious gram-negative isolates (Citrobacter diversus, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis) with Cefdinir. Contraindicated/inactive against Pseudomonas and Enterobacter species. Clinical significance of Cefdinir for these organisms is unknown.

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

FEB 1 6 1999

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

Re: K984489 Trade Name: Sensititre 18-24 Hour Susceptibility Plates Regulatory Class: II Product Code: JWY Dated: December 15, 1998 Received: December 17, 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 (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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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 yours,

Steven Sutman

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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10(k) Number (if known): K984489

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 Cefdinir in the dilution range of 0.06 - 64 ug/ml to the Sensititre 18 - 24 hour MIC panel for testing non-fastidious gram negative isolates. There are no approved primary "Indications for Use" and the clinical significance of Cefdinir is unknown when evaluating Enterobacteriaceae or any other non-fastidious gram negative rods. In vitro data, without clinical correlation is provided for Citrobacter diversus, Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis. Cefdinir is inactive against Pseudomonas and Enterobacter species.

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Concurrence of CDRH. Office of Device Evaluation (ODE)

Woody Dubose

Division of Clinical Laboratory Devices 510(k) Number_K 98 44 89

Prescription Use Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96) .