← Product Code [MDB](/submissions/MI/subpart-c%E2%80%94microbiology-devices/MDB) · K993421 # BACT/ALERT SN (K993421) _Organon Teknika Corp. · MDB · Dec 14, 1999 · Microbiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/MDB/K993421 ## Device Facts - **Applicant:** Organon Teknika Corp. - **Product Code:** [MDB](/submissions/MI/subpart-c%E2%80%94microbiology-devices/MDB.md) - **Decision Date:** Dec 14, 1999 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 866.2560 - **Device Class:** Class 1 - **Review Panel:** Microbiology ## Indications for Use The BacT/ALERT SN Culture Bottles are used with the BacT/ALERT Microbial Detection Systems in qualitative procedures for recovery and detection of anaerobic microorganisms ( bacteria) from blood and other normally sterile body fluids. ## Device Story BacT/ALERT SN Culture Bottle provides nutritional/environmental conditions for anaerobic microorganism growth. Inoculated bottles are placed in BacT/ALERT Microbial Detection Systems for continuous incubation and monitoring. Device uses reflectance technology to detect CO2 production via an emulsion-based sensor. System monitors for microbial growth; results used by clinicians to identify blood/body fluid infections. Benefits include timely detection of anaerobic pathogens. Used in clinical laboratory settings by trained personnel. ## Clinical Evidence Bench testing only. Seeded studies performed on 11 microorganisms diluted in human blood. Compared recovery and detection times between BacT/ALERT SN bottle and BacT/Alert Standard Anaerobic bottle. Results showed comparable performance in recovery of low levels of microorganisms and detection times. ## Technological Characteristics Reflectance-based microbial growth monitor. Emulsion-based CO2 sensor. Compatible with BacT/ALERT Microbial Detection Systems. Qualitative detection of anaerobic bacteria. ## Regulatory Identification A microbial growth monitor is a device intended for medical purposes that measures the concentration of bacteria suspended in a liquid medium by measuring changes in light scattering properties, optical density, electrical impedance, or by making direct bacterial counts. The device aids in the diagnosis of disease caused by pathogenic microorganisms. ## Predicate Devices - BacT/Alert Standard Anaerobic Culture Bottle ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ K993421 DEC I 4 1999 510(k) Premarket Notification Organon Teknika Corporation BacT/ALERT SN 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: - 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 SN Culture Bottle Common or Usual Name: BacT/ALERT SN Culture Bottle Classification Name: Microbial Growth Monitor - (a)(3) An identification of the legally marketed device to which the submitter claims substantial equivalence; Device Equivalent to: BacT/Alert Standard Anaerobic Culture Bottle - A description of the device. (a)(4) Device Description: The BacT/ALERT SN Culture Bottle was developed for the same intended use as the current BacT/Alert Standard Anaerobic 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 SN Bottle. #### A statement of the intended use of the device. (a)(5) Device Intended Use: The BacT/ALERT SN Culture Bottles are used with the BacT/ALERT Microbial Detection Systems in qualitative procedures for recovery and detection of anaerobic microorganisms ( bacteria) from blood and other normally sterile body fluids. {1}------------------------------------------------ 510(k) Premarket Notification Organon Teknika Corporation BacT/ALERT SN 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 SN Culture Bottle utilizes the same detection technology as the BacT/ALERT Standard Anaerobic Culture Bottle. | FEATURES | BACT/ALERT SN CULTURE BOTTLE | BACT/ALERT STANDARD
ANAEROBIC CULTURE
BOTTLE | |--------------------------------------|----------------------------------------------|----------------------------------------------------| | Technology | Reflectance | Reflectance | | Color change based on CO2 production | Yes | Yes | | Sensor | Emulsion | Disc | | Indicator material | Yes, Same as Standard Anaerobic Bottle | Yes | | Growth of microorganisms | Yes, Equivalent to Standard Anaerobic Bottle | Yes | | Instrument Used | BacT/ALERT Microbial Detection Systems | BacT/ALERT Microbial
Detection Systems | | Sample Source | Blood, Body Fluids | Blood, Body Fluids | | Target Population | Adult | Adult | {2}------------------------------------------------ 510(k) Premarket Notification Organon Teknika Corporation BacT/ALERT SN 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 11 organisms diluted in human blood and inoculated into the BacT/ALERT SN bottle and the BacT/Alert Standard Anaerobic 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 SN culture bottle was substantially equivalent to the BacT/Alert Standard Anaerobic Culture Bottle based on recovery of low levels of the 11 microorganisms included in the study. Detection times were comparable in both bottles. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image is a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an emblem. The emblem is a stylized representation of a human figure, with three lines forming the head and upper body, and a flowing design below, possibly representing water or movement. DEC I 4 1999 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Ms. Rebecca A. Rivas Regulatory Affairs Administrator Organon Teknika Corporation 100 Akzo Avenue Durham, North Carolina 27712 K993421 Re: Trade Name: BacT/ALERT SN Culture Bottle Regulatory Class: I Product Code: MDB Dated: October 11, 1999 Received: October 12, 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}------------------------------------------------ 510(k) Premarket Notification Organon Teknika Corporation BacT/ALERT SN Culture Bottle Page ***_ of _*** ### K993421 510(k) Number (If known): BacT/ALERT SN Culture Bottle Device Name: # Indications For Usa: The BacT/ALERT SN Culture Bottles are used with the BacT/ALERT Microbial Detection Systems in qualitative procedures for recovery and detection of anaerobic microorganisms (bacteria) 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 D e Evaluation (ODE) Woody Dubres Division of Clinical Laboratory Devices K99342 510(k) Number Prescription Use (Per 21 CFR 801.109) ਼ੁਕ Over-The-Counter Use (Optional Format 1-2-96) --- **Source:** [https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/MDB/K993421](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/MDB/K993421) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com