BACT/ALERT 3D MICROBIAL DETECTION SYSTEM

{0}------------------------------------------------ # JUL 2 4 1998 # 510(k) PREMARKET NOTIFICATION BACT/ALERT 3D SYSTEM EXPANDED INDICATION FOR MYCOBACTERIA K981736 #### 510(K) SUMMARY 16.0 A 510(k) Summary follows for the BacT/Alert 3D with Mycobacteria Indication described in this submission. {1}------------------------------------------------ # 510(k) PREMARKET NOTIFICATION BACT/ALERT 3D SYSTEM EXPANDED INDICATION FOR MYCOBACTERIA ### 510(k) Summary #### The submitter's name, address, telephone number, a contact person, and the date the summary (a)(1) was prepared; Submitter's Name: Organon Teknika Corporation Organon Teknika Corporation Submitter's Address: 100 Akzo Avenue Durham, North Carolina 27712 Submitter's Telephone: (919) 620-2288 Submitter's Contact: Rebecca Rivas Date 510(k) Summary Prepared: May 15, 1998 - The name of the device, including the trade or proprietary name if applicable, the common or (a)(2) usual name, and the classification name, if known; Trade or Proprietary Name: BacT/Alert 3D Common or Usual Name: BacT/Alert 3D Classification Name: Microbial Growth Monitor - (a)(3) An identification of the legally marketed device to which the submitter claims substantial equivalence; Device Equivalent to: MB/BacT Mycobacteria Culture System #### A description of the device. (a)(4) Device Description: BacT/Alert 3D System with expanded Mycobacteria indication is used in the qualitative procedures for growth and detection of Mycobacteria in clinical specimens other than blood. - A statement of the intended use of the device. (a)(5) Device Intended Use: Used in qualitative procedures for growth and detection of Mycobacteria in clinical specimens other than blood. {2}------------------------------------------------ ## 510(k) PREMARKET NOTIFICATION BACT/ALERT 3D SYSTEM EXPANDED INDICATION FOR MYCOBACTERIA | predicate device. | | | |---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | Growth and detection of<br>Mycobacteria in Clinical<br>Specimens other than<br>blood. | Growth and detection of<br>Mycobacteria in Clinical<br>Specimens other than blood. | | Media | MB/BacT Process bottles<br>(K954468),Culture Media<br>with suitable nutritional<br>conditions to recover<br>mycobacterial species.<br>Containing Middlebrook<br>7H9 Broth, Pancreatic<br>Digest of Casein, Bovine<br>Serum Albumin,Catalase,<br>Purified Water. | MB/BacT Process<br>bottles(K954468),Culture<br>Media with suitable<br>nutritional conditions to<br>recover mycobacterial species.<br>Containing Middlebrook 7H9<br>Broth, Pancreatic Digest of<br>Casein, Bovine Serum<br>Albumin,Catalase, Purified<br>Water. | | Bottle Blocks | Sealed for spill control | Sealed for spill control | | Air Circulation | Shuts off when door is open | Shuts off when drawer is open | | Determination<br>for positivity | High enough amount of<br>acceleration of CO2<br>production, High enough<br>amount of long-term<br>growth, and high enough<br>total change (delta) in the<br>growth curve. | High enough amount of<br>acceleration of CO2<br>production, High enough<br>amount of long-term growth,<br>and high enough total change<br>(delta) in the growth curve. | | | MB/BacT Mycobacteria<br>System | BacT/Alert 3D with<br>Mycobacteria Indication | - A summary of the technological characteristics of the new device in comparison to those of the (a)(6) predicate device. {3}------------------------------------------------ # 510(k) PREMARKET NOTIFICATION BACT/ALERT 3D SYSTEM EXPANDED INDICATION FOR MYCOBACTERIA #### A brief discussion of the nonclinical tests submitted, referenced, or relied on in the Premarket (b)1) 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 in-house for 10 organisms at inoculum levels of 106 (high) and 102 (low) CFU/ml. Individual strains of each organism at the low inoculum level were inoculated into six bottles each. Three bottles were loaded into the current MB/BacT system, and three were loaded into the BacT 3D instrument. Individual strains of each organism at the high inoculum level were inoculated into two bottles each. One bottle was loaded into the current MB/BacT system, and one bottle was loaded into the BacT 3D Times to detection (in days) for each bottle were used to perform analysis for substantial instrument. equivalence between the two systems. Analysis of the times to detection showed no significant effect of detection system for either the high or low inoculum level. #### A brief discussion of the clinical tests submitted, referenced, or relied on in the Premarket b)(2) notification submission for a determination of substantial equivalency. A total of 311 isolates were cultured from clinical specimens on both the BacT/Alert 3D and the MB/BacT Mycobacteria Culture System. 22 isolates were positive on both the BacT/Alert 3D and the MB/BacT. An additional 14 isolates were found to be positive on the Bac 7/Alert 3D only. 8 additional isolates were found to be positive on the MB/BacT only. #### (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). Organon Teknika's BacT/Alert 3D System with mycobacteria indication utilizes the same culture media bottles and detection algorithms as the currently marketed predicate device the MB/Bacteria Culture System. Both systems are equivalent in the following respects: - 1. They both have the same intended use: For use in qualitative procedures for growth and detection of mycobacteria in clinical specimens other than blood. - 2. They both utilize the same culture media bottles and detection methodology. - The BacT/Alert 3D vielded test results comparable to that seen with the predicate device the 3. MB/BacT Mycobacteria Culture System. {4}------------------------------------------------ Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle. # The 2 1 1898 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Rebecca Rivas Requlatory Affairs Administrator Organon Teknika Corporation 100 Akzo Avenue Durham, North Carolina 27712 K981736 Re: Trade Name: BacT/Alert 3D with Mycobacteria Indication Requlatory Class: I Product Code: MDB Dated: June 24,1998 Received: June 25, 1998 Dear Ms. Rivas: or regulations. 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 provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls The general controls provisions of provisions of the Act. the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 Requlations, 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 requlation (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 {5}------------------------------------------------ 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 requlation entitled, "Misbranding by reference to premarket notification" Other general information on your (21 CFR 807.97). 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.qov/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 {6}------------------------------------------------ | <br>----- | | | |-----------|--|--| 10(k) Number (If known): Device Name: BACT/ALERT 3D WITH MYCOBACTERIA INDICATION Indications For Use: - THE BACT/ALERT 3D MICROBIAL DETECTION SESTEM WITH EXPRECTION OR MICORACTERIA IN IS USED IN QUALITATIVE PROCEDURES FOR GROWTH AND DETECTION OF MICOBACTERIA IN CLINICAL SPECIMENS OTHER THAN BLOOD. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Woody Dubois (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number K981736 Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use_ (Optional Format 1-2-96)