← Product Code [MDB](/submissions/MI/subpart-c%E2%80%94microbiology-devices/MDB) · K021123 # BACT/ALERT SN CULTURE BOTTLE (K021123) _bioMerieux, Inc. · MDB · Apr 26, 2002 · Microbiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/MDB/K021123 ## Device Facts - **Applicant:** bioMerieux, Inc. - **Product Code:** [MDB](/submissions/MI/subpart-c%E2%80%94microbiology-devices/MDB.md) - **Decision Date:** Apr 26, 2002 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 866.2560 - **Device Class:** Class 1 - **Review Panel:** Microbiology ## Indications for Use BacT/ALERT® SN Culture Bottles are used with the BacT/ALERT Microbial Detection System in qualitative procedures for the recovery and detection of anaerobic and facultative anaerobic microorganisms (bacteria) from blood and other normally sterile body fluids. ## Device Story BacT/ALERT SN Plastic Culture Bottle provides nutritional/environmental conditions for microbial growth. Inoculated bottles are placed into BacT/ALERT Microbial Detection Instruments for incubation and continuous monitoring. Device uses reflectance technology to detect CO2 production via a silicone emulsion sensor containing Xylenol Blue. Instrument monitors growth; alerts clinician to presence of microorganisms. Used in clinical laboratory settings by trained personnel. Output facilitates identification of blood/body fluid infections; enables timely clinical intervention. ## Clinical Evidence Bench testing only. Seeded studies performed using 9 microorganisms diluted in human blood. Compared recovery and detection times between plastic and glass bottles. Results showed equivalent performance in recovery and detection times for all tested organisms. ## Technological Characteristics Plastic culture bottle; utilizes reflectance technology; sensor consists of Xylenol Blue in silicone emulsion; detects CO2 production; compatible with BacT/ALERT Microbial Detection Systems. ## 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 SN Glass Culture Bottle ([K993421](/device/K993421.md)) ## 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}------------------------------------------------ APR 2 6 2002 K021123 510(k) Premarket Notification bioMérieux, Inc. BacT/ALERT SN (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: Submitter's Telephone: Submitter's Contact: 100 Rodolphe Street, Durham, North Carolina 27712 (919) 620-2373 Ron Sanyal Ron April 4, 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 SN Culture Bottle Common or Usual Name: BacT/ALERT SN 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 SN Glass Culture Bottle - A description of the device. (a)(4) Device Description: The BacT/ALERT SN Plastic Culture Bottle was developed for the same intended use as the current BacT/ALERT SN 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 SN Bottle. #### A statement of the intended use of the device. (a)(5) Device Intended Use: BacT/ALERT® SN Culture Bottles are used with the BacT/ALERT Microbial Detection System in qualitative procedures for the recovery and detection of anaerobic and facultative anaerobic microorganisms (bacteria) from blood and other normally sterile body fluids. {1}------------------------------------------------ ## 510(k) Premarket Notification bioMérieux, Inc. BacT/ALERT SN (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 SN Plastic Culture Bottle utilizes the same detection technology as the BacT/ALERT SN Glass Culture Bottle. The similarities and/or differences with marketed device are listed in Table (a) (6) 1. | FEATURES | BACT/ALERT SN PLASTIC
CULTURE BOTTLE | BACT/ALERT SN GLASS
CULTURE BOTTLE
(K993421) | |-----------------------------------------|-------------------------------------------|----------------------------------------------------| | 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 SN (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 9 organisms diluted in human blood and inoculated into the BacT/ALERT SN Plastic Culture bottle and the BacT/ALERT SN Glass Culture bottle. #### The conclusions drawn from the nonclinical and clinical tests that demonstrate that the (b)3) device is safe, as effective, and performed as well or better than the legally marketed device identified in (a)(3). The BacT/ALERT SN Plastic Culture Bottle was substantially equivalent to the BacT/ALERT SN The Dactive Bottle based on recovery of low levels of the 9 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 logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized design featuring a symbol that resembles an abstract caduceus or a stylized representation of human figures. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Ron Sanyal, M. Pharm., CQE, RAC Acting Head of Regulatory Affairs Biomerieux, Inc. 100 Rodolphe Street Durham, NC 27712 Re: k021123 Trade/Device Name: BacT/ALERT® SN Culture Bottle Regulation Number: 21 CFR 866.2560 Regulation Name: Microbial Growth Monitor Regulatory Class: Class I Product Code: MDB Dated: April 4, 2002 Received: April 8, 2002 Dear Mr. Sanyal: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 rate exaction 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 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 that FDA has made 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (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 1 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/odrh/dsma/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 bioMérieux, Inc. BacT/ALERT SN (Plastic) Culture Bottle Page 1 of 1 510(k) Number (if known):__ BacT/ALERT® SN Culture Bottle Device Name:_ Indications For Use: BacT/ALERT® SN Culture Bottles are used with the BacT/ALERT Microbial Detection System in qualitative procedures for the recovery and detection of anaerobic and facultative anaerobic microorganisms (bacteria) 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) Freddie L. Poole (Division Sign-Off) (DMsion Sign-Olir) Division of Clinical Laboratory Devices 12021123 510(k) Number. Prescription Use (Per 21 CFR 801.109) ાર Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (Optional Formal 1-2-96) -018 --- **Source:** [https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/MDB/K021123](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/MDB/K021123) **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. 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