BACTALERT FA

{0}------------------------------------------------ SEP 3 1999 510(k) Summary - The submitter's name, address, telephone number, a contact person, and the date the (a)(1) summary was prepared; Submitter's Name: Organon Teknika Corporation Submitter's Address: 100 Akzo Avenue Durham, North Carolina 27712 Submitter's Telephone: (919) 620-2288 Submitter's Contact: Rebecca A. Rivas Date 510(k) Summary Prepared: - The name of the device, including the trade or proprietary name if applicable, the common (a)(2) or usual name, and the classification name, if known; Trade or Proprietary Name: BacT/ALERT FA Culture Bottle Common or Usual Name: BacT/ALERT FA Culture Bottle Classification Name: Microbial Growth Monitor - An identification of the legally marketed device to which the submitter claims substantial (a)(3) equivalence; Device Equivalent to: BacT/Alert FAN Aerobic Culture Bottle - A description of the device. (a)(4) Device Description: The BacT/ALERT FA Culture Bottle was developed for the same intended use as the current BacT/Alert FAN Aerobic Culture Bottle, to provide suitable nutritional and environmental conditions for organisms commonly encountered in blood infections and normally sterile body fluids. An inoculated bottle is placed into the BacT/ALERT Microbial Detection Instruments where it is incubated and continuously monitored for the presence of microorganisms that will grow in the BacT/ALERT FA Bottle. ## (a)(5) A statement of the intended use of the device. Device Intended Use: The BacT/ALERT FA Culture Bottles are used with the BacT/ALERT Microbial Detection Systems in qualitative procedures for enhanced recovery and detection of aerobic and facultative anaerobic microorganisms ( bacteria and fungi) from blood and other normally sterile body fluids. 1 {1}------------------------------------------------ #### A summary of the technological characteristics of the new device in comparison to those of (a)(6) the predicate device. The BacT/ALERT FA Culture Bottle utilizes the same detection technology as the BacT/ALERT FAN Aerobic Culture Bottle. | FEATURES | BACT/ALERT FA CULTURE BOTTLE | BACT/ALERT FAN<br>AEROBIC CULTURE<br>BOTTLE | |-----------------------------------------|------------------------------------------|---------------------------------------------| | Technology | Reflectance | Reflectance | | Color change based on<br>CO2 production | YES | YES | | Sensor | Emulsion | Disc | | Indicator material | Yes, Same as FAN Aerobic Bottle | Yes | | Growth of<br>microorganisms | Yes, Equivalent to FAN Aerobic<br>Bottle | Yes | | Instrument Used | BacT/ALERT Microbial Detection Systems | BacT/ALERT Microbial<br>Detection Systems | | Sample Source | Blood, Body Fluids | Blood, Body Fluids | | Target Population | Adult | Adult | #### A brief discussion of the nonclinical tests submitted, referenced, or relied on in the (b)1) premarket notification submission for a determination of substantial equivalency. Testing was performed to establish the performance characteristics of the new device including: Seeded studies were performed on 23 organisms diluted in human blood and inoculated into the BacT/ALERT FA bottle and the BacT/Alert FAN bottle. {2}------------------------------------------------ ### (b)3) The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe, as effective, and performed as well or better than the legally marketed device identified in (a)(3). The BacT/ALERT FA culture bottle was substantially equivalent to the BacT/Alert FAN Culture Bottle based on recovery of low levels of the 23 microorganisms included in the study. Detection times in the test bottle were equivalent in both bottles. , {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird in flight, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 SEP --------------------------------------------------------------------------------------------------------------------------------------------------------------------------3 1999 Ms. Rebecca A. Rivas Regulatory Affairs Administrator Organon Teknika Corporation 100 Akzo Avenue Durham, North Carolina 27712 Re: K992400 Trade Name: BacT/ALERT FA Culture Bottle Regulatory Class: I Product Code: MDB Dated: July 16, 1999 Received: July 19, 1999 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 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 **_ of _** | 510(k) Number (If known): | ____________________________________________________________________________________________________________________________________________________ | |---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name: | BacT/ALERT FA Culture Bottle | Indications For Usa: The BacT/ALERT FA Culture Bottles are used with the BacT/ALERT Microbial Detection Systems in qualitative procedures for enhanced recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and fungi) from blood and other normally sterile body fluids. # (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concumence of CDRH, Office of Device Evaluation (ODE) Woody Dubois Division Sign Off) Division of Clinical Laboratory Devices 510(k) Number_K99 2400 Prescription Use (Per 21 CFR 801.109) ਨਵ Over-The-Counter Use (Optional Format 1-2-95)