← Product Code [MDB](/submissions/MI/subpart-c%E2%80%94microbiology-devices/MDB) · K992432 # BACT/ALERT FN (K992432) _Organon Teknika Corp. · MDB · Sep 24, 1999 · Microbiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/MDB/K992432 ## Device Facts - **Applicant:** Organon Teknika Corp. - **Product Code:** [MDB](/submissions/MI/subpart-c%E2%80%94microbiology-devices/MDB.md) - **Decision Date:** Sep 24, 1999 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 866.2560 - **Device Class:** Class 1 - **Review Panel:** Microbiology ## Indications for Use The BacT/ALERT FN Culture Bottles are used with the BacT/ALERT Microbial Detection Systems in qualitative procedures for enhanced recovery and detection of anaerobic microorganisms from blood and other normally sterile body fluids. ## Device Story BacT/ALERT FN Culture Bottle provides nutritional/environmental conditions for anaerobic microorganism growth; used with BacT/ALERT Microbial Detection Systems. Inoculated bottles are placed in the instrument for continuous incubation and monitoring. Detection relies on reflectance technology measuring CO2 production via an emulsion-based sensor. Instrument monitors growth; alerts clinician to presence of microorganisms. Facilitates diagnosis of blood infections; enables timely clinical intervention. ## Clinical Evidence Bench testing only. Performance established via seeded studies comparing recovery of eleven anaerobic organisms in human blood between the BacT/ALERT FN Culture Bottle and the predicate BacT/Alert FAN Anaerobic Culture Bottle. Results showed equivalent recovery and times to detection. ## Technological Characteristics Reflectance-based microbial detection; CO2 production monitoring; emulsion-based sensor; compatible with BacT/ALERT Microbial Detection Systems; intended for blood and sterile body fluids. ## 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 FAN 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}------------------------------------------------ SEP 2 4 1999 510(k) Premarket Notification Organon Teknika Corporation BacT/ALERT FN 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: July 19, 1999 - (a)(2) ( The name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known; Trade or Proprietary Name: BacT/ALERT FN Culture Bottle Common or Usual Name: BacT/ALERT FN 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 Anaerobic Culture Bottle #### (a)(4) A description of the device. The BacT/ALERT FN Culture Bottle was developed for the same Device Description: intended use as the current BacT/Alert FAN 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 Instrument where it is incubated and continously monitored for the presence of microorganisms that will grow in the BacT/ALERT FN Culture Bottle. - (a)(5) A statement of the intended use of the device. Device Intended Use: The BacT/ALERT FN Culture Bottles are used with the BacT/ALERT Microbial Detection Systems in qualitative procedures for enhanced recovery and detection of anaerobic microorganisms from blood and other normally sterile body fluids. {1}------------------------------------------------ ## (a)(6) A summary of the technological characteristics of the new device in comparison to those of the predicate device. The BacT/ALERT FN Culture Bottle utilizes the same detection technology as the BacT/ALERT FAN Anaerobic Culture Bottle. | FEATURES | BACT/ALERT FN CULTURE BOTTLE | BACT/ALERT FAN
ANAEROBIC CULTURE
BOTTLE | |-----------------------------------------|--------------------------------------------|-----------------------------------------------| | Technology | Reflectance | Reflectance | | Color change based on
CO₂ production | YES | YES | | Sensor | Emulsion | Disc | | Indicator material | Yes, Same as FAN Anaerobic
Bottle | Yes | | Growth of
microorganisms | Yes, Equivalent to FAN 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 | 1998 : : . {2}------------------------------------------------ 510(k) Premarket Notification Organon Teknika Corporation BacT/ALERT FN 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 eleven anaerobic organisms diluted in human blood. The inoculums were seeded into the BacT/ALERT FN Culture Bottle and the BacT/Alert FAN Anaerobic Culture Bottle. Recovery of the seeded organisms were compared between the two culture bottles. ### (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 FN Culture Bottle has the same intended use and uses the same detection methodology as the predicate device, the current BacT/Alert FAN Anaerobic Culture Bottle. BacT/ALERT FN Culture Bottle was found to be substantially equivalent to the BacT/Alert FAN Anaerobic Culture Bottle based on recovery of low levels of eleven anaerobic organisms. Times to detection were also equivalent between both the BacT/ALERT FN Culture Bottle and the predicate device, the current BacT/Alert FAN Anaerobic Culture Bottle. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three wavy lines representing its body and wings. The eagle is enclosed in a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle. SEP 2 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 Re: K992432 Trade Name: BacT/ALERT FN Culture Bottle Regulatory Class: I Product Code: MDB Dated: July 20, 1999 Received: July 21, 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 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 vour 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 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 FN Culture Bottle | Page | __________ of __________ | |------|--------------------------| |------|--------------------------| | 510(k) Number (If known): | K992432 | |---------------------------|---------| |---------------------------|---------| BacT/ALERT FN Culture Bottle Device Name: Indications For Usa: The BacT/ALERT FN Culture Bottles are used with the BacT/ALERT Microbial Detection Systems in qualitative procedures for enhanced recovery and detection of anaerobic microorganisms 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) Woody Dubose ical Laboratory Devices Division of C 510(k) Number Prescription Use (Per 21 CFR 801.109) ଠାର Over-The-Counter Use (Optional Format 1-2-98) --- **Source:** [https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/MDB/K992432](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/MDB/K992432) **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