BACT/ALERT CULTURE BOTTLES

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NOV 17, 1997 ### 510(K) Summary BacT/Alert® Culture Bottles - The submitter's name, address, telephone number, a contact person, and the date (a)(1) the summary was prepared; Submitter's Name: Organon Teknika Corporation Submitter's Address: 100 Akzo Avenue, Durham, North Carolina, 27712 USA Submitter's Telephone: (919) 620-2288 Submitter's Contact:Rebecca Rivas Date 510(k) Summary Prepared: - The name of the device, including the trade or proprietary name if applicable, the (a)(2) common or usual name, and the classification name, if known; Trade or Proprietary Name: BacT/Alert® Culture Bottle Common or Usual Name: Culture Bottles Classification Name: Microbial Growth Monitor #### An identification of the legally marketed device to which the submitter claims (a)(3) substantial equivalence; Device Equivalent to: Traditional Culture Methodology #### A description of the device. (a)(4) Device Description: The BacT/Alert® Culture Bottles contain media and an internal sensor that detects CO2 as an indicator of microbial growth when used in connection with the BacT/Alert® Microbial Detection System. #### A statement of the intended use of the device. (8)(5) BacT/Alert® Culture Bottles are used with BacT/Alert® Device Intended Use: Microbial Detection System in qualitative procedures for enhanced recovery and detection of aerobic and anaerobic microorganisms from blood and other body fluids. - A summary of the technological characteristics of the new device in comparison to (a)(6) those of the predicate device. The BacT/Alert® culture Bottles contain media and an internal sensor that detects CO2 as an indicator of microbial growth when used in connection with the BacT/Alert® Microbial Detection System. {1}------------------------------------------------ #### A brief discussion of the clinical tests submitted, referenced, or relied on in the (b)(2) premarket notification submission for a determination of substantial equivalency. Testing was performed to establish the performance characteristics of the new device including comparison to traditional culture methodology. #### The conclusions drawn from the nonclinical and clinical tests that demonstrate that (b)3) the device is as safe, as effective, and performed as well or better than the legally marketed device identified in (a)(3). Organon Teknika's BacT/Alert® Culture Bottles are used with the BacT/Alert® Microbial Detection System in qualitative procedures for enhanced recovery and detection of aerobic and anaerobic microorganisms from blood and other body fluids. It is substantially equivalent to conventional culture methodologies for detection of microorganisms from blood (K903505) and other body fluids. The assays are equivalent in the following respects: - 1. They have the same intended use: recovery and detection of aerobic and anaerobic microorganisms from body fluids. - 2. They are both in-vitro diagnostic test systems which are based on microbial growth in media. - 3. Organon Teknika's BacT/Alert® Culture Bottles yield test results comparable to that seen with conventional culture methodology. The data contained in this submission shows that BacT/Alert® Culture Bottles perform equivalent to conventional culture methodology and based on this information we hereby submit this premarket notification in accordance with section 510(k). {2}------------------------------------------------ Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads, representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The logo is simple and recognizable, and it is often used on official documents and websites. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 ## NOV 17 1997 Ms. Rebecca A. Rivas Requaltory Affairs Orqanon Teknika Corporation 100 Akzo Avenue Durham, North Carolina 27712 Re : K973305 BacT/Alert Blood Culture Bottles for body fluids Trade Name: III Requlatory Class: Tier: I Product Code: MDB Dated: Auqust 28, 1997 Received: September 3, 1997 Dear Ms. Rivas: 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 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 You provisions of the Federal Food, Druq, and Cosmetic Act (Act). 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 requirement, 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 Reqister. 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. {3}------------------------------------------------ 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 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 {4}------------------------------------------------ 510(k) Premarket Notification Organon Teknika Corporation BacT/Alert® Culture Bottle # 510(k) Number (If known): K973305 Device Name: BacT/Alert Culture Bottles (expanded indications) Indications For Use: BacT/Alert Culture Bottles are used with the BacT/Alert Microbial Detection System in qualitative procedures for recovery and detection of aerobic and anaerobic microorganisms from blood and other body fluids. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Arian Cooper sion Sign-Off Division of Clinical Laboratory Devices K9 510(k) Number Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use (Optional Format 1-2-96)