BACT/ALERT SV

{0}------------------------------------------------ K994343 ## FR 1 0 2000 510(k) Premarket Notification Organon Teknika Corporation BacT/ALERT SV Culture Bottle ### 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: December 22, 1999 - 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 SV Culture Bottle Common or Usual Name: BacT/ALERT SV 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 Standard Aerobic Culture Bottle - A description of the device. (a)(4) Device Description: The BacT/ALERT SV Culture Bottle was developed for the same intended use as the current BacT/Alert Standard 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 SV Bottle. #### A statement of the intended use of the device. (a)(5) Device Intended Use: The BacT/ALERT SV Culture Bottles are used with the BacT/ALERT Microbial Detection Systems in qualitative procedures for enhanced recovery and detection of aerobic microorganisms ( bacteria and fungi) from blood and other normally sterile body fluids. {1}------------------------------------------------ 510(k) Premarket Notification Organon Teknika Corporation BacT/ALERT SV Culture Bottle ### (a)(6) A summary of the technological characteristics of the new device in comparison to those of the predicate device. The BacT/ALERT SV Culture Bottle utilizes the same detection technology as the BacT/ALERT Standard Aerobic Culture Bottle. | FEATURES | BACT/ALERT SV CULTURE BOTTLE | BACT/ALERT STANDARD<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 Standard Aerobic<br>Bottle | Yes | | Growth of<br>microorganisms | Yes, Equivalent to Standard<br>Aerobic 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 | {2}------------------------------------------------ 510(k) Premarket Notification Organon Teknika Corporation BacT/ALERT SV Culture Bottle #### (b)1) A brief discussion of the nonclinical tests submitted, referenced, or relied on in the 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 SV bottle and the BacT/Alert Standard Aerobic bottle. ### The conclusions drawn from the nonclinical and clinical tests that demonstrate that the (b)3) device is as safe, as effective, and performed as well or better than the legally marketed device identified in (a)(3). ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ The BacT/ALERT SV culture bottle was substantially equivalent to the BacT/Alert Standard Culture Bottle based on recovery of low levels of the 23 microorganisms included in the study. Detection times 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 caduceus, which is a symbol often associated with healthcare. The caduceus is composed of three curved lines that resemble a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 # FEB 1 0 2000 Ms. Rebecca A. Rivas Regulatory Affairs Administrator Organon Teknika Coporation 100 Akzo Avenue Durham, North Carolina 27712 Re: K994343 Trade Name: BacT/ALERT SV Culture Bottle Regulatory Class: I Product Code: MDB Dated: December 22, 1999 Received: December 23, 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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 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" (21CFR 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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/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 {5}------------------------------------------------ 510(k) Premarket Notification Organon Teknika Corporation BacT/ALERT SV Culture Bottle > Page ਰੀ 510(k) Number (If known): BacT/ALERT SV Culture Bottle Device Name: Indications For Use: The BacT/ALERT SV Culture Bottles are used with the BacT/ALERT Microbial Detection Systems in qualitative procedures for enhanced recovery and detection of Detobic 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 PAI NEEDED) | Concurrence of CDRH, Office of Device Evaluation (ODE) | |--------------------------------------------------------| |--------------------------------------------------------| | | Wordy Dubow | |-----------------------------------------|---------------------| | | (Division Sign-Off) | | Division of Clinical Laboratory Devices | | | 510(k) Number | K994343 | | Prescription Use | Y | OR | Over-The-Counter Use | |----------------------|---|----|----------------------| | (Per 21 CFR 801.109) | | | (Optional Format 1 |