BACT/ALERT FA CULTURE BOTTLE

{0}------------------------------------------------ # APR 1 7 2002 K020813 #### 510(k) Premarket Notification bioMérieux, Inc. BacT/ALERT FA (Plastic) 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: bioMérieux, Inc. Submitter's Address: 100 Rodolphe Street, Durham, North Carolina 27712 (919) 620-2373 Submitter's Telephone: Submitter's Contact: Ron Sanyal March 8, 2002 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 FA Glass Culture Bottle - A description of the device. (a)(4) Device Description: The BacT/ALERT FA Plastic Culture Bottle was developed for the same intended use as the current BacT/ALERT FA Glass 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 statement of the intended use of the device. (a)(5) Device Intended Use: 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}------------------------------------------------ #### 510(k) Premarket Notification bioMérieux, Inc. BacT/ALERT FA (Plastic) Culture Bottle #### A summary of the technological characteristics of the new device in comparison to those of (a)(6) the predicate device. : The BacT/ALERT FA Plastic Culture Bottle utilizes the same detection technology as the BacT/ALERT FA Glass Culture Bottle. The similarities and/or differences with marketed device are listed in Table (a) (6) 1. | FEATURES | BACT/ALERT FA PLASTIC CULTURE BOTTLE | BACT/ALERT FA GLASS CULTURE BOTTLE (K992400) | |--------------------------------------|----------------------------------------|----------------------------------------------| | Intended Use | Same | Same | | Culture Bottle Material | Plastic | Glass | | Product Code | MDB | MDB | | Technology | Reflectance | Reflectance | | Color change based on CO2 production | YES | YES | | Sensor | Emulsion | Emulsion | | Indicator material | Xylenol Blue in Silicone Emulsion | Xylenol Blue in Silicone Emulsion | | Growth of microorganisms | Same | Same | | Instrument Used | BacT/ALERT Microbial Detection Systems | BacT/ALERT Microbial Detection Systems | | Sample Source | Blood, Body Fluids | Blood, Body Fluids | | Target Population | Adult | Adult | ### TABLE (a) (6) 1. {2}------------------------------------------------ #### 510(k) Premarket Notification bioMérieux, Inc. BacT/ALERT FA (Plastic) Culture Bottle #### 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 Plastic Culture bottle and the BacT/ALERT FA Glass Culture bottle. #### The conclusions drawn from the nonclinical and clinical tests that demonstrate that the (b)3) Inc concreassafe, as effective, and performed as well or better than the legally marketed device identified in (a)(3). The BacT/ALERT FA Plastic Culture Bottle was substantially equivalent to the BacT/ALERT FA Glass Culture Bottle based on recovery of low levels of the 23 microorganisms included in the study. Detection times were equivalent in both bottles. {3}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three human profiles incorporated into its design. The eagle's wings are represented by the profiles, creating a sense of unity and human connection. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Ron Sanyal, M. Pharm., CQE, RAC Manager, Regulatory Affairs Biomerieux, Inc. 100 Rodolphe Street Durham, NC 27712 APR 1 7 2002 Re: k020813 Trade/Device Name: BacT/ALERT® FA Culture Bottle Regulation Number: 21 CFR 866.2560 Regulation Name: Microbial Growth Monitor Regulatory Class: Class I Product Code: MDB Dated: March 8, 2002 Received: March 13, 2002 Dear Mr. Sanyal: We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to conniner of the 10 May 20, 1977, in ecordance with the provisions of the Federal Food, Drug, devices mat nave occh roomstile in quire approval of a premarket approval application (PMA). and Cosmeter For (110) and the device, subject to the general controls provisions of the Act. The I ou may, therefore, maines of the Act include requirements for annual registration, listing of general controls pro resuring practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classined too as controls. Existing major regulations affecting your device can may oe subject to basil adales and Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean I touse of actived a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I vactar banates and securements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It Fat 60775 morems (21 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {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 International and Consumer 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 bioMérieux, Inc. BacT/ALERT FN (Plastic) Culture Bottle Page 1 of 1: | 510(k) Number (If known): | K020813 | |---------------------------|-------------------------------| | | BacT/ALERT® FA Culture Bottle | Device Name: Indications For Use: 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) Concurrence of CDRH, Office of Device Evaluation (ODE) | (Division Sigr | | |----------------------|--------------------------| | Division of C | atory Devices | | 510(k) Number | K020813 | | Prescription Use | ✓ | | (Per 21 CFR 801.109) | OR | | | Over-The-Counter Use | | | (Optional Format 1-2-96) |