CEFDINIR, 5 UG, SENSI-DISC

{0}------------------------------------------------ JUN - 9 1998 K981517 Date April 27, 1998 ## SUMMARY OF SAFETY AND EFFECTIVENESS ### SUBMITTED BY: Virginia C. Weinknecht Regulatory Affairs Specialist Becton Dickinson Microbiology Systems 7 Loveton Circle Sparks, MD 21152-0999 NAME OF DEVICE: | Trade Name: | Cefdinir, 5 µg, Sensi-Discs<br>Catalog Numbers 4331713 and 4331714 | |--------------------------|----------------------------------------------------------------------| | Common Name/Description: | Antimicrobial Susceptibility Test Discs | | Classification Name: | Antimicrobial Susceptibility Test Discs | | PREDICATE DEVICE: | Other BBL® Sensi-Discs® such as<br>Ciprofloxacin, 5 mcg, Sensi-Disc® | DEVICE DESCRIPTION: ## INTENDED USE: Antimicrobial Susceptibility Test Discs are used for semi-quantitative in vitro susceptibility testing by standardized agar diffusion test procedures. Cefdinir Sensi-Discs® are intended for use in determining the susceptibility to Cefdinir of a wide range of bacteria, as described under Indications For Use below. Zone sizes used for interpretation of tests, including control organism limits, were determined by the antimicrobic manufacturer, Parke-Davis, a Division of Warner-Lambert Co., and received FDA approval under NDA Nos. 50-739 and 50-749. #### INDICATIONS FOR USE: Use of BBL® Cefdinir Sensi-Discs® for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to Cefdinir. Cefdinir has been shown to be active against most {1}------------------------------------------------ strains of microorganisms listed below, as described in the Parke-Davis package insert for this antimicrobic. ## Active In Vitro and In Clinical Infections Against: Aerobic Gram-Positive Microorganisms Staphylococcus aureus (including ß-lactamase producing strains, but excluding methicillin-resistant staphylococci) Streptococcus pneumoniae (penicillin-susceptible strains only) Streptococcus pvogenes #### Aerobic Gram-Neqative Microorganisms Haemophilus influenzae (including ß-lactamase producing strains) Haemophilus parainfluenzae (including ß-lactamase producing strains) Moraxella catarrhalis (including ß-lactamase producing strains) ## Active In Vitro Only Against: Aerobic Gram-Positive Microorganisms Staphylococcus epidermidis (methicillin-susceptible strains only) Streptococcus agalactiae Viridans group streptococci Aerobic Gram Negative Microorganisms Citrobacter diversus Escherichia coli Klebsiella pneumoniae Proteus mirabilis #### PRODUCT DESCRIPTION: Cefdinir Susceptibility Test Discs are prepared by impregnating high quality paper with accurately determined amounts of Cefdinir supplied by the manufacturer. Parke-Davis. Each Cefdinir disc is clearly marked on both sides with the agent and content. Cefdinir discs are furnished in cartridges of 50 discs each. Cefdinir cartridges are packed as either a single cartridge in a single box, or in a package containing ten cartridges. Agar diffusion methods employing dried filter paper discs impregnated with specific concentrations of antimicrobial agents were developed in the 1940's. In order to eliminate or minimize variability in the testing, Bauer et al developed a standardized procedure in which Mueller Hinton Agar was selected as the test medium. Various regulatory agencies and standards-writing organizations subsequently published standardized reference procedures based on the Bauer-Kirby method. Among the earliest and most widely accepted of these standardized B-2 {2}------------------------------------------------ procedures were those published by the U.S. Food and Drug Administration (FDA) and the World Health Organization (WHO). The procedure was adopted as a consensus standard by the National Committee for Clinical Laboratory Standards (NCCLS) and is periodically updated. The latest NCCLS documents are M2-A6 (1/97) and M100-S8 (1/98). Discs containing a wide variety of antimicrobial agents are applied to the surface of Mueller Hinton Agar plates [or Haemophilus Test Medium Agar for Haemophilus influenzae or Mueller Hinton Agar with 5% Sheep Blood for Streptococcus pneumoniae] inoculated with pure cultures of clinical isolates. Following incubation, the plates are examined and the zones of inhibition surrounding the discs are measured and compared with established zone size ranges for individual antimicrobial agents in order to determine the agent(s) most suitable for use in antimicrobial therapy. The determination as to whether the organism in question is susceptible (S), intermediate (I), or resistant (R) to an antimicrobial agent is made by comparing zone sizes to those found in the respective organism tables of National Committee for Clinical Laboratory Standards (NCCLS) Document M2-A6 ("Performance Standards for Antimicrobial Disk Susceptibility Tests - Sixth Edition, Approved Standard", 1/97) and of NCCLS Document M100-S8 ("Performance Standards for Antimicrobial Susceptibility Testing", Eighth Informational Supplement, 1/98). #### PERFORMANCE DATA: See attached Parke-Davis product insert section on Susceptibility Tests - Diffusion Techniques for Omnicef® capsules and Omnicef® for Oral Suspension. {3}------------------------------------------------ Image /page/3/Picture/2 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" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. # JUN - 9 1998 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Virginia C. Weinknecht Regulatory Affairs Specialist Becton Dickinson Microbiology Systems 7 Loveton Circle Sparks, Maryland 21152-0999 K981517 Re: Trade Name: Cefdinir, 5ug, Sensi-Disc Regulatory Class: II Product Code: JTN Dated: April 27, 1998 Received: April 28, 1998 Dear Ms. Weinknecht: 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. {4}------------------------------------------------ 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 (770)488-7655. 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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or at (301) 443-6597 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 {5}------------------------------------------------ Page 1 of 1 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: Cefdinir, 5 ug, Sensi-Disc® #### Indications For Use: Use of BBL Cefdinir Sensi-Discs® for in vitro agar diffusion susceptibility testing is indicated when there is a need to determine the susceptibility of bacteria to Cefdinir. Cefdinir has been shown to be active In Vitro against most strains of microorganisms listed below, as described in the Parke-Davis package insert for this antimicrobic. #### Active In Vitro Against: #### Aerobic Gram-Positive Microorganisms Staphylococus aureus (including B-lactamase producing stains, but excluding methicillinresistant staphylococci) Staphylococcus epidermidis (methicillin-susceptible strains only) ### Aerobic Gram-Negative Microorganisms Haemophilus influenzae (including (3-lactamase producing strains) Haemophilus parainfluenzae (including ß-lactamase producing strains) Moraxella catarrhalis (including ß-lactamase producing stains) Escherichia coli Kiebsiella pneumoniae Proteus mirabilis (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | Concurrence of CDRH, Office of Device Evaluation (ODE) | | |--------------------------------------------------------|---------------| | (Division Sign-Off) | Woodly Dubois | | Division of Clinical Laboratory Devices | | | 510(k) Number | K981517 | Prescription Use Per 21 CFR 801.109 OR Over-The-Counter Use _ Optional Format 1-2-96