K Number
K992400
Device Name
BACTALERT FA
Date Cleared
1999-09-03

(46 days)

Product Code
Regulation Number
866.2560
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 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.
Device Description
The BacT/ALERT FA Culture Bottle was developed for the same intended use as the current BacT/Alert FAN Aerobic 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.
More Information

BacT/Alert FAN Aerobic Culture Bottle

Not Found

No
The summary describes a culture bottle and a microbial detection system that monitors for growth, but there is no mention of AI or ML in the device description, intended use, or performance studies.

No.
The device is used for detection of microorganisms, which is a diagnostic purpose, not for treating any condition.

Yes
The device is used for the "detection of aerobic and facultative anaerobic microorganisms (bacteria and fungi) from blood and other normally sterile body fluids," which is a diagnostic procedure to identify the presence of pathogens.

No

The device description clearly states it is a "Culture Bottle" and is used with "BacT/ALERT Microbial Detection Instruments," indicating it is a physical component (a bottle) and interacts with hardware (the instruments).

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use explicitly states it's for "qualitative procedures for enhanced recovery and detection of aerobic and facultative anaerobic microorganisms ( bacteria and fungi) from blood and other normally sterile body fluids." This describes a test performed in vitro (outside the body) on a biological sample (blood and body fluids) to provide information about a patient's health status (presence of microorganisms).
  • Device Description: The description further clarifies that the bottle is inoculated with a sample and then placed into a system that monitors for the presence of microorganisms. This is a typical process for an in vitro diagnostic test.
  • Anatomical Site: The samples are taken from "Blood and other normally sterile body fluids," which are biological specimens used for in vitro testing.

The core function of the device is to facilitate the detection of microorganisms in vitro from patient samples, which is the definition of an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

The 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.

Product codes

MDB

Device Description

The BacT/ALERT FA Culture Bottle was developed for the same intended use as the current BacT/Alert FAN Aerobic 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Blood, Body Fluids

Indicated Patient Age Range

Adult

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Seeded studies were performed on 23 organisms diluted in human blood and inoculated into the BacT/ALERT FA bottle and the BacT/Alert FAN bottle.

Summary of Performance Studies

The performance characteristics of the new device were established through testing, including seeded studies. The BacT/ALERT FA culture bottle was found to be substantially equivalent to the BacT/Alert FAN Culture Bottle based on the recovery of low levels of 23 microorganisms. Detection times in both bottles were equivalent.

Key Metrics

Not Found

Predicate Device(s)

BacT/Alert FAN Aerobic Culture Bottle

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 866.2560 Microbial growth monitor.

(a)
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.(b)
Classification. Class I. With the exception of automated blood culturing system devices that are used in testing for bacteria, fungi, and other microorganisms in blood and other normally sterile body fluids, this device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.

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SEP 3 1999

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 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 FAN Aerobic Culture Bottle

  • A description of the device. (a)(4)
    Device Description: The BacT/ALERT FA Culture Bottle was developed for the same intended use as the current BacT/Alert FAN Aerobic 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)(5) A statement of the intended use of the device.

Device Intended Use: The 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.

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1

A summary of the technological characteristics of the new device in comparison to those of (a)(6) the predicate device.

The BacT/ALERT FA Culture Bottle utilizes the same detection technology as the BacT/ALERT FAN Aerobic Culture Bottle.

| FEATURES | BACT/ALERT FA CULTURE BOTTLE | BACT/ALERT FAN
AEROBIC CULTURE
BOTTLE |
|-----------------------------------------|------------------------------------------|---------------------------------------------|
| Technology | Reflectance | Reflectance |
| Color change based on
CO2 production | YES | YES |
| Sensor | Emulsion | Disc |
| Indicator material | Yes, Same as FAN Aerobic Bottle | Yes |
| Growth of
microorganisms | Yes, Equivalent to FAN Aerobic
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 |

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 bottle and the BacT/Alert FAN bottle.

2

(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 FA culture bottle was substantially equivalent to the BacT/Alert FAN Culture Bottle based on recovery of low levels of the 23 microorganisms included in the study. Detection times in the test bottle were equivalent in both bottles.

,

3

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird in flight, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP --------------------------------------------------------------------------------------------------------------------------------------------------------------------------3 1999

Ms. Rebecca A. Rivas Regulatory Affairs Administrator Organon Teknika Corporation 100 Akzo Avenue Durham, North Carolina 27712

Re: K992400 Trade Name: BacT/ALERT FA Culture Bottle Regulatory Class: I Product Code: MDB Dated: July 16, 1999 Received: July 19, 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.

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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

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Page _ of _

510(k) Number (If known):____________________________________________________________________________________________________________________________________________________
Device Name:BacT/ALERT FA Culture Bottle

Indications For Usa:

The 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)

Concumence of CDRH, Office of Device Evaluation (ODE)

Woody Dubois

Division Sign Off) Division of Clinical Laboratory Devices 510(k) Number_K99 2400

Prescription Use (Per 21 CFR 801.109)

ਨਵ

Over-The-Counter Use

(Optional Format 1-2-95)