SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH GREPAFLOXACIN

K983306 · Accumed Intl., Inc. · LTT · Dec 18, 1998 · Microbiology

Device Facts

• Record ID: K983306
• Device Name: SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH GREPAFLOXACIN
• Applicant: Accumed Intl., Inc.
• Product Code: LTT · Microbiology
• Decision Date: Dec 18, 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 Grepafloxacin in the difution range of 0.002 - 4 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 Grepafloxacin is unknown when evaluating Enterobacteriaceae, Pseudomonas, or any other non-fastidious gram negative rods.

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 Grepafloxacin to existing panels. The system utilizes micro-dilution plates containing specific concentrations of antimicrobial agents. Clinical laboratory technicians inoculate the plates with patient-derived bacterial isolates; plates are incubated for 18-24 hours. Growth or inhibition is observed to determine susceptibility. Results assist clinicians in selecting appropriate antibiotic therapy for patients with bacterial infections. The device is intended for prescription use only.

Clinical Evidence

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

Technological Characteristics

Micro-dilution susceptibility test panel; contains dehydrated antimicrobial agents (Grepafloxacin) in specific concentration ranges (0.002 - 4 ug/ml). Designed for use with non-fastidious gram-negative and gram-positive organisms. Standardized for 18-24 hour incubation periods.

Indications for Use

Indicated for in vitro clinical susceptibility testing of non-fastidious gram-negative and gram-positive organisms using Grepafloxacin (0.002 - 4 ug/ml). Clinical significance of Grepafloxacin for Enterobacteriaceae, Pseudomonas, or other non-fastidious gram-negative rods 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)

{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 stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 1 8 1998

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

K983306 Re: Trade Name: Sensititre 18-24 Hour Susceptibility Plates Grepafloxacin Regulatory Class: II Product Code: LTT, JTW Dated: September 4, 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 (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.

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

## Page 2

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

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

10(k) Number (if known): K983306

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 Grepafloxacin in the difution range of 0.002 - 4 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 Grepafloxacin is unknown when evaluating Enterobacteriaceae, Pseudomonas, or any other non-fastidious gram negative rods.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Woody Debres

nical Laboratory Devices (983306 510(k) Number

Prescription Use Per 21 CFR 801.109)

OR

Over-The-Counter Use